Trial Outcomes & Findings for A Study to Evaluate the Pharmacokinetics (PK) of Medroxyprogesterone Acetate Following an Injection of TV-46046 in Healthy Women of Reproductive Age (NCT NCT04682353)
NCT ID: NCT04682353
Last Updated: 2024-02-26
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
Day 0 to Day 365
Results posted on
2024-02-26
Participant Flow
Participant milestones
| Measure |
TV46046 Dose A
Participants received a single subcutaneous (SC) injection of TV-46046 Dose A.
|
TV46046 Dose B
Participants received a single SC injection of TV-46046 Dose B.
|
TV46046 Dose C
Participants received a single SC injection of TV-46046 Dose C.
|
Depo-subQ Provera
Participants received a single SC injection of Depo-subQ Provera.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
14
|
15
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
16
|
15
|
14
|
15
|
|
Overall Study
COMPLETED
|
16
|
13
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
1
|
Reasons for withdrawal
| Measure |
TV46046 Dose A
Participants received a single subcutaneous (SC) injection of TV-46046 Dose A.
|
TV46046 Dose B
Participants received a single SC injection of TV-46046 Dose B.
|
TV46046 Dose C
Participants received a single SC injection of TV-46046 Dose C.
|
Depo-subQ Provera
Participants received a single SC injection of Depo-subQ Provera.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
1
|
|
Overall Study
Personal reasons
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate the Pharmacokinetics (PK) of Medroxyprogesterone Acetate Following an Injection of TV-46046 in Healthy Women of Reproductive Age
Baseline characteristics by cohort
| Measure |
TV46046 Dose A
n=16 Participants
Participants received a single SC injection of TV-46046 Dose A.
|
TV46046 Dose B
n=15 Participants
Participants received a single SC injection of TV-46046 Dose B.
|
TV46046 Dose C
n=14 Participants
Participants received a single SC injection of TV-46046 Dose C.
|
Depo-subQ Provera
n=15 Participants
Participants received a single SC injection of Depo-subQ Provera.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
35.3 years
STANDARD_DEVIATION 6.1 • n=39 Participants
|
33.9 years
STANDARD_DEVIATION 7.2 • n=41 Participants
|
31.2 years
STANDARD_DEVIATION 7.2 • n=35 Participants
|
32.9 years
STANDARD_DEVIATION 6.3 • n=31 Participants
|
33.4 years
STANDARD_DEVIATION 6.7 • n=146 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=39 Participants
|
15 Participants
n=41 Participants
|
14 Participants
n=35 Participants
|
15 Participants
n=31 Participants
|
60 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
5 Participants
n=31 Participants
|
11 Participants
n=146 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
21 Participants
n=146 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
27 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
PRIMARY outcome
Timeframe: Day 0 to Day 365Population: Pharmacokinetic (PK) analysis set included all randomized participants who received an injection of study drug, excluding any participants who had a baseline MPA concentration that exceeded 5% of their individual Cmax, had an important protocol deviation that may affect interpretation of their MPA data, or failed to provide at least 1 evaluable post-treatment MPA specimen.
Outcome measures
| Measure |
TV46046 Dose A
n=16 Participants
Participants received a single SC injection of TV-46046 Dose A.
|
TV46046 Dose B
n=15 Participants
Participants received a single SC injection of TV-46046 Dose B.
|
TV46046 Dose C
n=14 Participants
Participants received a single SC injection of TV-46046 Dose C.
|
Depo-subQ Provera
n=14 Participants
Participants received a single SC injection of Depo-subQ Provera.
|
|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) of Medroxyprogesterone Acetate (MPA)
|
0.940 nanograms (ng)/ milliliter (mL)
Geometric Coefficient of Variation 41.187
|
1.180 nanograms (ng)/ milliliter (mL)
Geometric Coefficient of Variation 39.076
|
1.750 nanograms (ng)/ milliliter (mL)
Geometric Coefficient of Variation 41.407
|
0.963 nanograms (ng)/ milliliter (mL)
Geometric Coefficient of Variation 47.672
|
PRIMARY outcome
Timeframe: Day 0 to Day 365Population: PK analysis set included all randomized participants who received an injection of study drug, excluding any participants who had a baseline MPA concentration that exceeded 5% of their individual Cmax, had an important protocol deviation that may affect interpretation of their MPA data, or failed to provide at least 1 evaluable post-treatment MPA specimen.
Outcome measures
| Measure |
TV46046 Dose A
n=16 Participants
Participants received a single SC injection of TV-46046 Dose A.
|
TV46046 Dose B
n=15 Participants
Participants received a single SC injection of TV-46046 Dose B.
|
TV46046 Dose C
n=14 Participants
Participants received a single SC injection of TV-46046 Dose C.
|
Depo-subQ Provera
n=14 Participants
Participants received a single SC injection of Depo-subQ Provera.
|
|---|---|---|---|---|
|
Time to Reach Cmax (Tmax) of MPA
|
17.0 days
Interval 1.0 to 105.0
|
28.0 days
Interval 1.0 to 71.0
|
6.0 days
Interval 2.0 to 336.0
|
31.5 days
Interval 1.0 to 105.0
|
PRIMARY outcome
Timeframe: Day 91Population: PK analysis set included all randomized participants who received an injection of study drug, excluding any participants who had a baseline MPA concentration that exceeded 5% of their individual Cmax, had an important protocol deviation that may affect interpretation of their MPA data, or failed to provide at least 1 evaluable post-treatment MPA specimen.
Outcome measures
| Measure |
TV46046 Dose A
n=16 Participants
Participants received a single SC injection of TV-46046 Dose A.
|
TV46046 Dose B
n=15 Participants
Participants received a single SC injection of TV-46046 Dose B.
|
TV46046 Dose C
n=14 Participants
Participants received a single SC injection of TV-46046 Dose C.
|
Depo-subQ Provera
n=14 Participants
Participants received a single SC injection of Depo-subQ Provera.
|
|---|---|---|---|---|
|
Serum MPA Concentration at Day 91 (C91)
|
0.570 ng/mL
Geometric Coefficient of Variation 36.802
|
0.660 ng/mL
Geometric Coefficient of Variation 49.360
|
1.090 ng/mL
Geometric Coefficient of Variation 40.151
|
0.474 ng/mL
Geometric Coefficient of Variation 37.765
|
PRIMARY outcome
Timeframe: Day 182Population: PK analysis set included all randomized participants who received an injection of study drug, excluding any participants who had a baseline MPA concentration that exceeded 5% of their individual Cmax, had an important protocol deviation that may affect interpretation of their MPA data, or failed to provide at least 1 evaluable post-treatment MPA specimen. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Outcome measures
| Measure |
TV46046 Dose A
n=16 Participants
Participants received a single SC injection of TV-46046 Dose A.
|
TV46046 Dose B
n=13 Participants
Participants received a single SC injection of TV-46046 Dose B.
|
TV46046 Dose C
n=13 Participants
Participants received a single SC injection of TV-46046 Dose C.
|
Depo-subQ Provera
n=12 Participants
Participants received a single SC injection of Depo-subQ Provera.
|
|---|---|---|---|---|
|
Serum MPA Concentration at Day 182 (C182)
|
0.201 ng/mL
Geometric Coefficient of Variation 69.429
|
0.279 ng/mL
Geometric Coefficient of Variation 65.793
|
0.443 ng/mL
Geometric Coefficient of Variation 60.531
|
0.118 ng/mL
Geometric Coefficient of Variation 150.789
|
PRIMARY outcome
Timeframe: Day 210Population: PK analysis set included all randomized participants who received an injection of study drug, excluding any participants who had a baseline MPA concentration that exceeded 5% of their individual Cmax, had an important protocol deviation that may affect interpretation of their MPA data, or failed to provide at least 1 evaluable post-treatment MPA specimen. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Outcome measures
| Measure |
TV46046 Dose A
n=16 Participants
Participants received a single SC injection of TV-46046 Dose A.
|
TV46046 Dose B
n=15 Participants
Participants received a single SC injection of TV-46046 Dose B.
|
TV46046 Dose C
n=14 Participants
Participants received a single SC injection of TV-46046 Dose C.
|
Depo-subQ Provera
n=13 Participants
Participants received a single SC injection of Depo-subQ Provera.
|
|---|---|---|---|---|
|
Serum MPA Concentration at Day 210 (C210)
|
0.119 ng/mL
Geometric Coefficient of Variation 105.727
|
0.208 ng/mL
Geometric Coefficient of Variation 76.683
|
0.365 ng/mL
Geometric Coefficient of Variation 69.357
|
0.063 ng/mL
Geometric Coefficient of Variation 244.107
|
PRIMARY outcome
Timeframe: Day 0 to Day 182Population: PK analysis set included all randomized participants who received an injection of study drug, excluding any participants who had a baseline MPA concentration that exceeded 5% of their individual Cmax, had an important protocol deviation that may affect interpretation of their MPA data, or failed to provide at least 1 evaluable post-treatment MPA specimen.
Outcome measures
| Measure |
TV46046 Dose A
n=16 Participants
Participants received a single SC injection of TV-46046 Dose A.
|
TV46046 Dose B
n=15 Participants
Participants received a single SC injection of TV-46046 Dose B.
|
TV46046 Dose C
n=14 Participants
Participants received a single SC injection of TV-46046 Dose C.
|
Depo-subQ Provera
n=14 Participants
Participants received a single SC injection of Depo-subQ Provera.
|
|---|---|---|---|---|
|
Area Under the Serum Drug Concentration-Time Curve From Time 0 to Day 182 (AUC0-182) of MPA
|
94.2 days*ng/mL
Geometric Coefficient of Variation 27.0
|
121.8 days*ng/mL
Geometric Coefficient of Variation 38.1
|
173.6 days*ng/mL
Geometric Coefficient of Variation 25.8
|
86.1 days*ng/mL
Geometric Coefficient of Variation 29.6
|
PRIMARY outcome
Timeframe: Day 0 to Day 210Population: PK analysis set included all randomized participants who received an injection of study drug, excluding any participants who had a baseline MPA concentration that exceeded 5% of their individual Cmax, had an important protocol deviation that may affect interpretation of their MPA data, or failed to provide at least 1 evaluable post-treatment MPA specimen.
Outcome measures
| Measure |
TV46046 Dose A
n=16 Participants
Participants received a single SC injection of TV-46046 Dose A.
|
TV46046 Dose B
n=15 Participants
Participants received a single SC injection of TV-46046 Dose B.
|
TV46046 Dose C
n=14 Participants
Participants received a single SC injection of TV-46046 Dose C.
|
Depo-subQ Provera
n=14 Participants
Participants received a single SC injection of Depo-subQ Provera.
|
|---|---|---|---|---|
|
Area Under the Serum Drug Concentration-Time Curve From Time 0 to Day 210 (AUC0-210) of MPA
|
100.2 days*ng/mL
Geometric Coefficient of Variation 23.9
|
129.6 days*ng/mL
Geometric Coefficient of Variation 37.8
|
187.0 days*ng/mL
Geometric Coefficient of Variation 26.0
|
90.1 days*ng/mL
Geometric Coefficient of Variation 27.6
|
PRIMARY outcome
Timeframe: Day 0 to Day 365Population: PK analysis set included all randomized participants who received an injection of study drug, excluding any participants who had a baseline MPA concentration that exceeded 5% of their individual Cmax, had an important protocol deviation that may affect interpretation of their MPA data, or failed to provide at least 1 evaluable post-treatment MPA specimen. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Outcome measures
| Measure |
TV46046 Dose A
n=16 Participants
Participants received a single SC injection of TV-46046 Dose A.
|
TV46046 Dose B
n=15 Participants
Participants received a single SC injection of TV-46046 Dose B.
|
TV46046 Dose C
n=13 Participants
Participants received a single SC injection of TV-46046 Dose C.
|
Depo-subQ Provera
n=14 Participants
Participants received a single SC injection of Depo-subQ Provera.
|
|---|---|---|---|---|
|
Area Under the Serum Drug Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MPA
|
117.2 days*ng/mL
Geometric Coefficient of Variation 17.9
|
160.8 days*ng/mL
Geometric Coefficient of Variation 36.6
|
224.9 days*ng/mL
Geometric Coefficient of Variation 18.9
|
105.1 days*ng/mL
Geometric Coefficient of Variation 19.5
|
PRIMARY outcome
Timeframe: Day 0 to Day 365Population: PK analysis set included all randomized participants who received an injection of study drug, excluding any participants who had a baseline MPA concentration that exceeded 5% of their individual Cmax, had an important protocol deviation that may affect interpretation of their MPA data, or failed to provide at least 1 evaluable post-treatment MPA specimen. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Outcome measures
| Measure |
TV46046 Dose A
n=16 Participants
Participants received a single SC injection of TV-46046 Dose A.
|
TV46046 Dose B
n=15 Participants
Participants received a single SC injection of TV-46046 Dose B.
|
TV46046 Dose C
n=13 Participants
Participants received a single SC injection of TV-46046 Dose C.
|
Depo-subQ Provera
n=14 Participants
Participants received a single SC injection of Depo-subQ Provera.
|
|---|---|---|---|---|
|
Apparent Terminal Half-life (t½) of MPA
|
47.4 days
Interval 18.7 to 114.8
|
85.3 days
Interval 15.7 to 160.2
|
79.8 days
Interval 19.4 to 130.4
|
37.4 days
Interval 8.2 to 224.3
|
SECONDARY outcome
Timeframe: Day 0 up to Week 78Population: Safety analysis set included all randomized participants who received an injection of study drug.
Outcome measures
| Measure |
TV46046 Dose A
n=16 Participants
Participants received a single SC injection of TV-46046 Dose A.
|
TV46046 Dose B
n=15 Participants
Participants received a single SC injection of TV-46046 Dose B.
|
TV46046 Dose C
n=14 Participants
Participants received a single SC injection of TV-46046 Dose C.
|
Depo-subQ Provera
n=15 Participants
Participants received a single SC injection of Depo-subQ Provera.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
11 Participants
|
10 Participants
|
8 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Day 0 up to Week 78Population: Safety analysis set included all randomized participants who received an injection of study drug.
Concomitant medications included acetic acid derivatives and substances, aminoalkyl ethers, anilides, calcium compounds, other viral vaccines, and propionic acid derivatives etc.
Outcome measures
| Measure |
TV46046 Dose A
n=16 Participants
Participants received a single SC injection of TV-46046 Dose A.
|
TV46046 Dose B
n=15 Participants
Participants received a single SC injection of TV-46046 Dose B.
|
TV46046 Dose C
n=14 Participants
Participants received a single SC injection of TV-46046 Dose C.
|
Depo-subQ Provera
n=15 Participants
Participants received a single SC injection of Depo-subQ Provera.
|
|---|---|---|---|---|
|
Number of Participants With at Least 1 Concomitant Medication Use During Treatment
|
11 Participants
|
8 Participants
|
6 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Day 0 to Day 365Population: Safety analysis set included all randomized participants who received an injection of study drug.
Vital signs examination included blood pressure, respiration rate, pulse, and body temperature.
Outcome measures
| Measure |
TV46046 Dose A
n=16 Participants
Participants received a single SC injection of TV-46046 Dose A.
|
TV46046 Dose B
n=15 Participants
Participants received a single SC injection of TV-46046 Dose B.
|
TV46046 Dose C
n=14 Participants
Participants received a single SC injection of TV-46046 Dose C.
|
Depo-subQ Provera
n=15 Participants
Participants received a single SC injection of Depo-subQ Provera.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Signs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 7 and Weeks 13, 26, and 52Population: Safety analysis set included all randomized participants who received an injection of study drug. Here, 'Number analyzed' = participants evaluable at specified timepoint.
Outcome measures
| Measure |
TV46046 Dose A
n=16 Participants
Participants received a single SC injection of TV-46046 Dose A.
|
TV46046 Dose B
n=15 Participants
Participants received a single SC injection of TV-46046 Dose B.
|
TV46046 Dose C
n=14 Participants
Participants received a single SC injection of TV-46046 Dose C.
|
Depo-subQ Provera
n=15 Participants
Participants received a single SC injection of Depo-subQ Provera.
|
|---|---|---|---|---|
|
Change From Baseline in Body Weight at Day 7 and Weeks 13, 26, and 52
Change at Day 7
|
-0.21 kilograms (kg)
Standard Error 0.19
|
-0.27 kilograms (kg)
Standard Error 0.20
|
-0.33 kilograms (kg)
Standard Error 0.17
|
0.05 kilograms (kg)
Standard Error 0.28
|
|
Change From Baseline in Body Weight at Day 7 and Weeks 13, 26, and 52
Change at Week 13
|
-1.10 kilograms (kg)
Standard Error 1.42
|
0.92 kilograms (kg)
Standard Error 0.65
|
0.84 kilograms (kg)
Standard Error 0.35
|
1.40 kilograms (kg)
Standard Error 0.87
|
|
Change From Baseline in Body Weight at Day 7 and Weeks 13, 26, and 52
Change at Week 26
|
1.14 kilograms (kg)
Standard Error 0.58
|
2.91 kilograms (kg)
Standard Error 1.11
|
1.38 kilograms (kg)
Standard Error 0.74
|
2.68 kilograms (kg)
Standard Error 0.89
|
|
Change From Baseline in Body Weight at Day 7 and Weeks 13, 26, and 52
Change at Week 52
|
0.60 kilograms (kg)
Standard Error 0.56
|
1.38 kilograms (kg)
Standard Error 1.00
|
0.79 kilograms (kg)
Standard Error 1.06
|
1.99 kilograms (kg)
Standard Error 0.91
|
SECONDARY outcome
Timeframe: Weeks 13, 26, and 52Population: Safety analysis set included all randomized participants who received an injection of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
Number of participants with overall opinion of vaginal bleeding pattern as acceptable or not acceptable has been reported.
Outcome measures
| Measure |
TV46046 Dose A
n=16 Participants
Participants received a single SC injection of TV-46046 Dose A.
|
TV46046 Dose B
n=14 Participants
Participants received a single SC injection of TV-46046 Dose B.
|
TV46046 Dose C
n=14 Participants
Participants received a single SC injection of TV-46046 Dose C.
|
Depo-subQ Provera
n=15 Participants
Participants received a single SC injection of Depo-subQ Provera.
|
|---|---|---|---|---|
|
Number of Participants With Overall Opinion of Vaginal Bleeding Pattern
Week 52 · Not Acceptable
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Overall Opinion of Vaginal Bleeding Pattern
Week 13 · Acceptable
|
10 Participants
|
9 Participants
|
11 Participants
|
11 Participants
|
|
Number of Participants With Overall Opinion of Vaginal Bleeding Pattern
Week 13 · Not Acceptable
|
6 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Overall Opinion of Vaginal Bleeding Pattern
Week 26 · Acceptable
|
12 Participants
|
13 Participants
|
9 Participants
|
12 Participants
|
|
Number of Participants With Overall Opinion of Vaginal Bleeding Pattern
Week 26 · Not Acceptable
|
4 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Overall Opinion of Vaginal Bleeding Pattern
Week 52 · Acceptable
|
14 Participants
|
12 Participants
|
13 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 13, 26, and 52Population: Safety analysis set included all randomized participants who received an injection of study drug. Here, 'Number analyzed' = participants evaluable at specified timepoint.
The PHQ-9 is a participant-rated depressive symptom severity scale to monitor severity over time for newly diagnosed participants or participants in current treatment for depression. Scoring was based on participants' responses to each of the 9 questions, as follows: 0=not at all; 1=several days; 2=more than half the days; and 3=nearly every day. The PHQ-9 total score was calculated as the sum of the 9 individual item scores. The PHQ-9 total score was categorized as follows: 0 = no depression, 1 to 4=minimal depression, 5 to 9=mild depression, 10 to 14=moderate depression, 15 to 19=moderately severe depression; and 20 to 27=severe depression. Higher scores indicate more severe depression.
Outcome measures
| Measure |
TV46046 Dose A
n=16 Participants
Participants received a single SC injection of TV-46046 Dose A.
|
TV46046 Dose B
n=15 Participants
Participants received a single SC injection of TV-46046 Dose B.
|
TV46046 Dose C
n=14 Participants
Participants received a single SC injection of TV-46046 Dose C.
|
Depo-subQ Provera
n=15 Participants
Participants received a single SC injection of Depo-subQ Provera.
|
|---|---|---|---|---|
|
Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores
Baseline · No Depression
|
12 Participants
|
9 Participants
|
10 Participants
|
9 Participants
|
|
Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores
Baseline · Minimal Depression
|
4 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores
Baseline · Mild Depression
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores
Baseline · Moderate Depression
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores
Baseline · Moderately Severe Depression
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores
Baseline · Severe Depression
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores
Week 4 · No Depression
|
9 Participants
|
10 Participants
|
9 Participants
|
6 Participants
|
|
Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores
Week 4 · Minimal Depression
|
5 Participants
|
4 Participants
|
3 Participants
|
7 Participants
|
|
Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores
Week 4 · Mild Depression
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores
Week 4 · Moderate Depression
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores
Week 4 · Moderately Severe Depression
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores
Week 4 · Severe Depression
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores
Week 13 · No Depression
|
8 Participants
|
6 Participants
|
9 Participants
|
9 Participants
|
|
Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores
Week 13 · Minimal Depression
|
6 Participants
|
7 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores
Week 13 · Mild Depression
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores
Week 13 · Moderate Depression
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores
Week 13 · Moderately Severe Depression
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores
Week 13 · Severe Depression
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores
Week 26 · No Depression
|
10 Participants
|
7 Participants
|
10 Participants
|
10 Participants
|
|
Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores
Week 26 · Minimal Depression
|
4 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores
Week 26 · Mild Depression
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores
Week 26 · Moderate Depression
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores
Week 26 · Moderately Severe Depression
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores
Week 26 · Severe Depression
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores
Week 52 · No Depression
|
11 Participants
|
6 Participants
|
10 Participants
|
12 Participants
|
|
Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores
Week 52 · Minimal Depression
|
4 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores
Week 52 · Mild Depression
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores
Week 52 · Moderate Depression
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores
Week 52 · Moderately Severe Depression
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores
Week 52 · Severe Depression
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 0 to Day 365Population: Safety analysis set included all randomized participants who received an injection of study drug.
Outcome measures
| Measure |
TV46046 Dose A
n=16 Participants
Participants received a single SC injection of TV-46046 Dose A.
|
TV46046 Dose B
n=15 Participants
Participants received a single SC injection of TV-46046 Dose B.
|
TV46046 Dose C
n=14 Participants
Participants received a single SC injection of TV-46046 Dose C.
|
Depo-subQ Provera
n=15 Participants
Participants received a single SC injection of Depo-subQ Provera.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Liver Function Tests
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 13, 26, 30, and 52Population: Safety analysis set included all randomized participants who received an injection of study drug. Here, 'Number analyzed' = participants evaluable at specified timepoint.
Outcome measures
| Measure |
TV46046 Dose A
n=16 Participants
Participants received a single SC injection of TV-46046 Dose A.
|
TV46046 Dose B
n=15 Participants
Participants received a single SC injection of TV-46046 Dose B.
|
TV46046 Dose C
n=14 Participants
Participants received a single SC injection of TV-46046 Dose C.
|
Depo-subQ Provera
n=15 Participants
Participants received a single SC injection of Depo-subQ Provera.
|
|---|---|---|---|---|
|
Estradiol Concentrations
Baseline
|
64.988 picograms (pg)/mL
Standard Deviation 57.169
|
52.825 picograms (pg)/mL
Standard Deviation 22.857
|
63.962 picograms (pg)/mL
Standard Deviation 74.815
|
66.181 picograms (pg)/mL
Standard Deviation 64.843
|
|
Estradiol Concentrations
Week 4
|
72.357 picograms (pg)/mL
Standard Deviation 38.855
|
49.027 picograms (pg)/mL
Standard Deviation 48.373
|
31.149 picograms (pg)/mL
Standard Deviation 13.394
|
55.699 picograms (pg)/mL
Standard Deviation 28.077
|
|
Estradiol Concentrations
Week 13
|
62.389 picograms (pg)/mL
Standard Deviation 56.316
|
45.890 picograms (pg)/mL
Standard Deviation 30.475
|
36.337 picograms (pg)/mL
Standard Deviation 25.065
|
42.071 picograms (pg)/mL
Standard Deviation 30.137
|
|
Estradiol Concentrations
Week 26
|
114.347 picograms (pg)/mL
Standard Deviation 67.997
|
177.369 picograms (pg)/mL
Standard Deviation 197.661
|
52.132 picograms (pg)/mL
Standard Deviation 38.971
|
105.234 picograms (pg)/mL
Standard Deviation 67.421
|
|
Estradiol Concentrations
Week 30
|
133.892 picograms (pg)/mL
Standard Deviation 138.964
|
77.861 picograms (pg)/mL
Standard Deviation 58.685
|
81.301 picograms (pg)/mL
Standard Deviation 58.232
|
142.691 picograms (pg)/mL
Standard Deviation 163.819
|
|
Estradiol Concentrations
Week 52
|
122.994 picograms (pg)/mL
Standard Deviation 108.549
|
171.966 picograms (pg)/mL
Standard Deviation 166.209
|
148.441 picograms (pg)/mL
Standard Deviation 140.495
|
103.951 picograms (pg)/mL
Standard Deviation 63.290
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Safety analysis set included all randomized participants who received an injection of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Ovulation was defined as one or more progesterone measurements ≥ 4.7 ng/mL in Weeks 48, 49, 50, 51 or 52.
Outcome measures
| Measure |
TV46046 Dose A
n=15 Participants
Participants received a single SC injection of TV-46046 Dose A.
|
TV46046 Dose B
n=13 Participants
Participants received a single SC injection of TV-46046 Dose B.
|
TV46046 Dose C
n=13 Participants
Participants received a single SC injection of TV-46046 Dose C.
|
Depo-subQ Provera
n=13 Participants
Participants received a single SC injection of Depo-subQ Provera.
|
|---|---|---|---|---|
|
Number of Participants With No Ovulation in 12 Months
|
4 Participants
|
7 Participants
|
8 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 0 to Day 365Population: Safety analysis set included all randomized participants who received an injection of study drug.
The ISRs included erythema, swelling, pruritus, bleeding, tenderness, bruising, hypopigmentation, atrophy, and injection site pain.
Outcome measures
| Measure |
TV46046 Dose A
n=16 Participants
Participants received a single SC injection of TV-46046 Dose A.
|
TV46046 Dose B
n=15 Participants
Participants received a single SC injection of TV-46046 Dose B.
|
TV46046 Dose C
n=14 Participants
Participants received a single SC injection of TV-46046 Dose C.
|
Depo-subQ Provera
n=15 Participants
Participants received a single SC injection of Depo-subQ Provera.
|
|---|---|---|---|---|
|
Number of Participants With 1 or More Injection Site Reactions (ISRs)
|
7 Participants
|
6 Participants
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Weeks 26 and 52Population: Safety analysis set included all randomized participants who received an injection of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category.
Acceptability questions include likes and dislikes of the method and willingness to use the product in the future.
Outcome measures
| Measure |
TV46046 Dose A
n=16 Participants
Participants received a single SC injection of TV-46046 Dose A.
|
TV46046 Dose B
n=13 Participants
Participants received a single SC injection of TV-46046 Dose B.
|
TV46046 Dose C
n=14 Participants
Participants received a single SC injection of TV-46046 Dose C.
|
Depo-subQ Provera
n=14 Participants
Participants received a single SC injection of Depo-subQ Provera.
|
|---|---|---|---|---|
|
Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)
Week 26: Weight loss
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)
Week 26: Easy to use
|
7 Participants
|
7 Participants
|
7 Participants
|
8 Participants
|
|
Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)
Week 26: Weight gain
|
2 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)
Week 26: Menstrual changes
|
6 Participants
|
5 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)
Week 26: Discreet
|
8 Participants
|
8 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)
Week 26: Provides longer-term protection than other method
|
6 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)
Week 26: Few side effects
|
5 Participants
|
5 Participants
|
6 Participants
|
2 Participants
|
|
Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)
Week 26: Has to be administered by a healthcare provider
|
2 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)
Week 26: Nothing
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)
Week 26: Other
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)
Week 52: Easy to use
|
13 Participants
|
11 Participants
|
10 Participants
|
11 Participants
|
|
Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)
Week 52: Weight gain
|
2 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)
Week 52: Weight loss
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)
Week 52: Menstrual changes
|
5 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)
Week 52: Discreet
|
7 Participants
|
6 Participants
|
6 Participants
|
9 Participants
|
|
Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)
Week 52: Provides longer-term protection than other method
|
7 Participants
|
8 Participants
|
3 Participants
|
10 Participants
|
|
Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)
Week 52: Few side effects
|
10 Participants
|
5 Participants
|
7 Participants
|
6 Participants
|
|
Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)
Week 52: Has to be administered by a healthcare provider
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)
Week 52: Nothing
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)
Week 52: Other
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Weeks 26 and 52Population: Safety analysis set included all randomized participants who received an injection of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category.
Acceptability questions include likes and dislikes of the method and willingness to use the product in the future.
Outcome measures
| Measure |
TV46046 Dose A
n=16 Participants
Participants received a single SC injection of TV-46046 Dose A.
|
TV46046 Dose B
n=13 Participants
Participants received a single SC injection of TV-46046 Dose B.
|
TV46046 Dose C
n=14 Participants
Participants received a single SC injection of TV-46046 Dose C.
|
Depo-subQ Provera
n=14 Participants
Participants received a single SC injection of Depo-subQ Provera.
|
|---|---|---|---|---|
|
Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)
Week 26: Pain at injection
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)
Week 26: Once injected, it cannot be reversed
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)
Week 26: Weight gain
|
1 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
|
Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)
Week 26: Weight loss
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)
Week 26: Nothing
|
5 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)
Week 26: Menstrual changes
|
7 Participants
|
6 Participants
|
8 Participants
|
4 Participants
|
|
Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)
Week 26: Injection site reactions
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)
Week 26: Other side effects
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)
Week 26: Other
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)
Week 52: Pain at injection
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)
Week 52: Once injected, it cannot be reversed
|
4 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)
Week 52: Weight gain
|
1 Participants
|
4 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)
Week 52: Weight loss
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)
Week 52: Nothing
|
5 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)
Week 52: Menstrual changes
|
8 Participants
|
8 Participants
|
6 Participants
|
3 Participants
|
|
Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)
Week 52: Injection site reactions
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)
Week 52: Other side effects
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)
Week 52: Other
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Weeks 26 and 52Population: Safety analysis set included all randomized participants who received an injection of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
Acceptability questions include likes and dislikes of the method and willingness to use the product in the future.
Outcome measures
| Measure |
TV46046 Dose A
n=16 Participants
Participants received a single SC injection of TV-46046 Dose A.
|
TV46046 Dose B
n=12 Participants
Participants received a single SC injection of TV-46046 Dose B.
|
TV46046 Dose C
n=14 Participants
Participants received a single SC injection of TV-46046 Dose C.
|
Depo-subQ Provera
n=14 Participants
Participants received a single SC injection of Depo-subQ Provera.
|
|---|---|---|---|---|
|
Number of Participants With Responses to the Acceptability Question (If You Were at Risk for Pregnancy, Would You Use This Method of Contraception Outside of This Study?)
Week 26 · Yes
|
4 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Responses to the Acceptability Question (If You Were at Risk for Pregnancy, Would You Use This Method of Contraception Outside of This Study?)
Week 26 · No
|
11 Participants
|
10 Participants
|
10 Participants
|
9 Participants
|
|
Number of Participants With Responses to the Acceptability Question (If You Were at Risk for Pregnancy, Would You Use This Method of Contraception Outside of This Study?)
Week 52 · Yes
|
2 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Responses to the Acceptability Question (If You Were at Risk for Pregnancy, Would You Use This Method of Contraception Outside of This Study?)
Week 52 · No
|
14 Participants
|
10 Participants
|
11 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Weeks 26 and 52Population: Safety analysis set included all randomized participants who received an injection of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
Acceptability questions include likes and dislikes of the method and willingness to use the product in the future.
Outcome measures
| Measure |
TV46046 Dose A
n=16 Participants
Participants received a single SC injection of TV-46046 Dose A.
|
TV46046 Dose B
n=13 Participants
Participants received a single SC injection of TV-46046 Dose B.
|
TV46046 Dose C
n=13 Participants
Participants received a single SC injection of TV-46046 Dose C.
|
Depo-subQ Provera
n=14 Participants
Participants received a single SC injection of Depo-subQ Provera.
|
|---|---|---|---|---|
|
Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)
Week 52 · Injection every 1 month
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)
Week 52 · Frequency of reinjections is not important
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)
Week 26 · Injection every 1 month
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)
Week 26 · Injection every 3 months
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)
Week 26 · Injection every 6 months
|
6 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)
Week 26 · Injection every 12 months
|
5 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)
Week 26 · Frequency of reinjections is not important
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)
Week 52 · Injection every 3 months
|
3 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)
Week 52 · Injection every 6 months
|
2 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)
Week 52 · Injection every 12 months
|
10 Participants
|
6 Participants
|
7 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Weeks 48, 49, 50, 51, and 52Population: Safety analysis set included all randomized participants who received an injection of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
Outcome measures
| Measure |
TV46046 Dose A
n=16 Participants
Participants received a single SC injection of TV-46046 Dose A.
|
TV46046 Dose B
n=13 Participants
Participants received a single SC injection of TV-46046 Dose B.
|
TV46046 Dose C
n=14 Participants
Participants received a single SC injection of TV-46046 Dose C.
|
Depo-subQ Provera
n=14 Participants
Participants received a single SC injection of Depo-subQ Provera.
|
|---|---|---|---|---|
|
Progesterone Concentration
Week 48
|
2.103 ng/mL
Standard Deviation 3.993
|
0.945 ng/mL
Standard Deviation 2.422
|
2.255 ng/mL
Standard Deviation 4.395
|
2.682 ng/mL
Standard Deviation 3.900
|
|
Progesterone Concentration
Week 49
|
1.803 ng/mL
Standard Deviation 3.268
|
2.448 ng/mL
Standard Deviation 3.784
|
1.593 ng/mL
Standard Deviation 3.471
|
4.323 ng/mL
Standard Deviation 5.276
|
|
Progesterone Concentration
Week 50
|
4.793 ng/mL
Standard Deviation 6.791
|
5.224 ng/mL
Standard Deviation 7.554
|
1.649 ng/mL
Standard Deviation 3.085
|
3.086 ng/mL
Standard Deviation 5.312
|
|
Progesterone Concentration
Week 51
|
4.280 ng/mL
Standard Deviation 7.133
|
0.795 ng/mL
Standard Deviation 0.928
|
1.214 ng/mL
Standard Deviation 2.737
|
1.669 ng/mL
Standard Deviation 3.390
|
|
Progesterone Concentration
Week 52
|
2.096 ng/mL
Standard Deviation 4.319
|
2.264 ng/mL
Standard Deviation 4.167
|
2.561 ng/mL
Standard Deviation 5.069
|
2.529 ng/mL
Standard Deviation 4.152
|
Adverse Events
TV46046 Dose A
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
TV46046 Dose B
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
TV46046 Dose C
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Depo-subQ Provera
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TV46046 Dose A
n=16 participants at risk
Participants received a single SC injection of TV-46046 Dose A.
|
TV46046 Dose B
n=15 participants at risk
Participants received a single SC injection of TV-46046 Dose B.
|
TV46046 Dose C
n=14 participants at risk
Participants received a single SC injection of TV-46046 Dose C.
|
Depo-subQ Provera
n=15 participants at risk
Participants received a single SC injection of Depo-subQ Provera.
|
|---|---|---|---|---|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/16 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
Other adverse events
| Measure |
TV46046 Dose A
n=16 participants at risk
Participants received a single SC injection of TV-46046 Dose A.
|
TV46046 Dose B
n=15 participants at risk
Participants received a single SC injection of TV-46046 Dose B.
|
TV46046 Dose C
n=14 participants at risk
Participants received a single SC injection of TV-46046 Dose C.
|
Depo-subQ Provera
n=15 participants at risk
Participants received a single SC injection of Depo-subQ Provera.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
6.2%
1/16 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/16 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/16 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/16 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 3 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/16 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
General disorders
Fatigue
|
12.5%
2/16 • Number of events 2 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
13.3%
2/15 • Number of events 2 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
7.1%
1/14 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
General disorders
Injection site erythema
|
6.2%
1/16 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
7.1%
1/14 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
General disorders
Injection site pain
|
12.5%
2/16 • Number of events 2 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
7.1%
1/14 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/16 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/16 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Infections and infestations
Amoebic dysentery
|
6.2%
1/16 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/16 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 2 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/16 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
7.1%
1/14 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Infections and infestations
COVID-19
|
0.00%
0/16 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
7.1%
1/14 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Infections and infestations
Furuncle
|
0.00%
0/16 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
7.1%
1/14 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Infections and infestations
Gastroenteritis
|
6.2%
1/16 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/16 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Infections and infestations
Mastitis
|
0.00%
0/16 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/16 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
13.3%
2/15 • Number of events 2 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/16 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
7.1%
1/14 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Infections and infestations
Tinea infection
|
0.00%
0/16 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/16 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
7.1%
1/14 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/16 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
7.1%
1/14 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
1/16 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Infections and infestations
Viral infection
|
0.00%
0/16 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 2 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/16 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
7.1%
1/14 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/16 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
7.1%
1/14 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/16 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/16 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/16 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/16 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Investigations
Weight increased
|
0.00%
0/16 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/16 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Metabolism and nutrition disorders
Increased appetite
|
12.5%
2/16 • Number of events 2 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/16 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 2 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/16 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
7.1%
1/14 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
1/16 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal deformity
|
0.00%
0/16 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Nervous system disorders
Headache
|
37.5%
6/16 • Number of events 8 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
13.3%
2/15 • Number of events 4 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
7.1%
1/14 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
26.7%
4/15 • Number of events 4 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/16 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.00%
0/16 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/16 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/16 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
7.1%
1/14 • Number of events 2 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Reproductive system and breast disorders
Breast pain
|
12.5%
2/16 • Number of events 3 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
6.2%
1/16 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Reproductive system and breast disorders
Nipple pain
|
6.2%
1/16 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
6.2%
1/16 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Reflux laryngitis
|
0.00%
0/16 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.2%
1/16 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/16 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.00%
0/16 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
6.7%
1/15 • Number of events 1 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/14 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
0.00%
0/15 • Day 0 up to Week 78
Safety analysis set included all randomized participants who received an injection of study drug.
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products, R&D Inc.
Phone: 888-483-8279
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
- Publication restrictions are in place
Restriction type: OTHER