Trial Outcomes & Findings for Safety and Efficacy of PROMETRIUM® Capsules in Induction of Secretory Conversion (NCT NCT00160199)
NCT ID: NCT00160199
Last Updated: 2010-07-07
Results Overview
Endometrial biopsy results were classified as : Secretory (Complete or partial), Non-secretory, Unable to determine or Unknown after an evaluation of morphologic criteria.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
240 participants
Primary outcome timeframe
End of the study (Days 85)
Results posted on
2010-07-07
Participant Flow
Subjects were recruited in 42 centers in US between November 2004 and February 2009. Before the randomization, subjects were evaluated for eligibility. In total 240 subjects were randomized.
The Baseline characteristics are presented using the Full Analysis Sample (FAS) to be online with the Efficacy analysis results.
Participant milestones
| Measure |
Prometrium 300 mg/Day
|
Prometrium 400 mg/Day
|
|---|---|---|
|
Overall Study
STARTED
|
122
|
118
|
|
Overall Study
COMPLETED
|
98
|
81
|
|
Overall Study
NOT COMPLETED
|
24
|
37
|
Reasons for withdrawal
| Measure |
Prometrium 300 mg/Day
|
Prometrium 400 mg/Day
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
14
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
7
|
7
|
|
Overall Study
Withdrawal by Subject
|
4
|
6
|
|
Overall Study
Administrative
|
0
|
1
|
|
Overall Study
Protocol Violation
|
8
|
8
|
Baseline Characteristics
Safety and Efficacy of PROMETRIUM® Capsules in Induction of Secretory Conversion
Baseline characteristics by cohort
| Measure |
Prometrium 300 mg/Day
n=107 Participants
|
Prometrium 400 mg/Day
n=99 Participants
|
Total
n=206 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
29.2 years
STANDARD_DEVIATION 6.63 • n=99 Participants
|
28.7 years
STANDARD_DEVIATION 6.35 • n=107 Participants
|
29.0 years
STANDARD_DEVIATION 6.49 • n=206 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=99 Participants
|
99 Participants
n=107 Participants
|
206 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
107 participants
n=99 Participants
|
99 participants
n=107 Participants
|
206 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: End of the study (Days 85)Population: The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated.
Endometrial biopsy results were classified as : Secretory (Complete or partial), Non-secretory, Unable to determine or Unknown after an evaluation of morphologic criteria.
Outcome measures
| Measure |
Prometrium 300 mg/Day
n=107 Participants
|
Prometrium 400 mg/Day
n=99 Participants
|
|---|---|---|
|
Secretory Conversion of the Endometrium
Secretory
|
23 participants
|
28 participants
|
|
Secretory Conversion of the Endometrium
Non-Secretory
|
70 participants
|
53 participants
|
|
Secretory Conversion of the Endometrium
Unable to determine
|
7 participants
|
9 participants
|
|
Secretory Conversion of the Endometrium
Unknown
|
4 participants
|
2 participants
|
PRIMARY outcome
Timeframe: After first and second cycle (cycle=28 days)Population: The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated.
This measure is the number of subjects with withdrawal bleeding using Last Observation Carried Forward (LOCF) after first and second cycle.
Outcome measures
| Measure |
Prometrium 300 mg/Day
n=107 Participants
|
Prometrium 400 mg/Day
n=99 Participants
|
|---|---|---|
|
Number of Subjects With Withdrawal Bleeding
|
93 participants
|
90 participants
|
SECONDARY outcome
Timeframe: Duration of withdrawal bleedPopulation: The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated.
The intensity of withdrawal bleeding was classified by: None, Spotting, Light, Moderate, Heavy
Outcome measures
| Measure |
Prometrium 300 mg/Day
n=107 Participants
|
Prometrium 400 mg/Day
n=99 Participants
|
|---|---|---|
|
Maximum Intensity of Withdrawal Bleeding After Any Cycle
Moderate (Modest amount-continuous staining)
|
25 participants
|
40 participants
|
|
Maximum Intensity of Withdrawal Bleeding After Any Cycle
Heavy (Large amount-heavy clots)
|
40 participants
|
33 participants
|
|
Maximum Intensity of Withdrawal Bleeding After Any Cycle
None
|
13 participants
|
8 participants
|
|
Maximum Intensity of Withdrawal Bleeding After Any Cycle
Spotting (Intermittent Staining)
|
10 participants
|
3 participants
|
|
Maximum Intensity of Withdrawal Bleeding After Any Cycle
Light (Slight amount-continuous staining)
|
18 participants
|
14 participants
|
SECONDARY outcome
Timeframe: End of the first cycle of treatment (cycle=28 days)Population: The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated.
The numbers of days the subjects actually bled after the end of the first treatment cycle.
Outcome measures
| Measure |
Prometrium 300 mg/Day
n=107 Participants
|
Prometrium 400 mg/Day
n=99 Participants
|
|---|---|---|
|
The Duration of Withdrawal Bleeding After the First Treatment Cycle
|
4.0 Days
Standard Deviation 2.03
|
3.8 Days
Standard Deviation 1.88
|
SECONDARY outcome
Timeframe: End of the second cycle of treatment (cycle=28 days)Population: The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated.
The numbers of days the subjects actually bled after the end of the second treatment cycle
Outcome measures
| Measure |
Prometrium 300 mg/Day
n=107 Participants
|
Prometrium 400 mg/Day
n=99 Participants
|
|---|---|---|
|
The Duration of Withdrawal Bleeding After Second Treatment Cycle
|
3.5 Days
Standard Deviation 2.15
|
3.8 Days
Standard Deviation 1.62
|
SECONDARY outcome
Timeframe: End of the first cycle of treatment (cycle=28 days)Population: The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated.
The number of days between the first cycle of treatment and the withdrawal bleeding.
Outcome measures
| Measure |
Prometrium 300 mg/Day
n=107 Participants
|
Prometrium 400 mg/Day
n=99 Participants
|
|---|---|---|
|
Time to Withdrawal Bleeding After First Treatment Cycle
|
1.9 Days
Standard Deviation 1.89
|
2.2 Days
Standard Deviation 1.81
|
SECONDARY outcome
Timeframe: End of the second cycle of treatment (cycle=28 days)Population: The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated.
The number of days between the second cycle of treatment and the withdrawal bleeding
Outcome measures
| Measure |
Prometrium 300 mg/Day
n=107 Participants
|
Prometrium 400 mg/Day
n=99 Participants
|
|---|---|---|
|
Time to Withdrawal Bleeding After Second Treatment Cycle
|
1.6 Days
Standard Deviation 1.99
|
2.21 Days
Standard Deviation 1.72
|
Adverse Events
Prometrium 300 mg/Day
Serious events: 2 serious events
Other events: 72 other events
Deaths: 0 deaths
Prometrium 400 mg/Day
Serious events: 1 serious events
Other events: 70 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prometrium 300 mg/Day
n=113 participants at risk
|
Prometrium 400 mg/Day
n=107 participants at risk
|
|---|---|---|
|
Reproductive system and breast disorders
Adnexa uteri mass
|
0.88%
1/113 • The adverse events presented were collected from start of drug treatment to the end of the treatment period.
The safety analysis is presented on the safety sample meaning the number of patients who were randomized and received at least one dose of study medication.
|
0.00%
0/107 • The adverse events presented were collected from start of drug treatment to the end of the treatment period.
The safety analysis is presented on the safety sample meaning the number of patients who were randomized and received at least one dose of study medication.
|
|
Nervous system disorders
Hydrocephalus
|
0.88%
1/113 • The adverse events presented were collected from start of drug treatment to the end of the treatment period.
The safety analysis is presented on the safety sample meaning the number of patients who were randomized and received at least one dose of study medication.
|
0.00%
0/107 • The adverse events presented were collected from start of drug treatment to the end of the treatment period.
The safety analysis is presented on the safety sample meaning the number of patients who were randomized and received at least one dose of study medication.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/113 • The adverse events presented were collected from start of drug treatment to the end of the treatment period.
The safety analysis is presented on the safety sample meaning the number of patients who were randomized and received at least one dose of study medication.
|
0.93%
1/107 • The adverse events presented were collected from start of drug treatment to the end of the treatment period.
The safety analysis is presented on the safety sample meaning the number of patients who were randomized and received at least one dose of study medication.
|
Other adverse events
| Measure |
Prometrium 300 mg/Day
n=113 participants at risk
|
Prometrium 400 mg/Day
n=107 participants at risk
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Acnes
|
7.1%
8/113 • The adverse events presented were collected from start of drug treatment to the end of the treatment period.
The safety analysis is presented on the safety sample meaning the number of patients who were randomized and received at least one dose of study medication.
|
6.5%
7/107 • The adverse events presented were collected from start of drug treatment to the end of the treatment period.
The safety analysis is presented on the safety sample meaning the number of patients who were randomized and received at least one dose of study medication.
|
|
General disorders
Asthenic conditions
|
9.7%
11/113 • The adverse events presented were collected from start of drug treatment to the end of the treatment period.
The safety analysis is presented on the safety sample meaning the number of patients who were randomized and received at least one dose of study medication.
|
6.5%
7/107 • The adverse events presented were collected from start of drug treatment to the end of the treatment period.
The safety analysis is presented on the safety sample meaning the number of patients who were randomized and received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Breast signs and symptoms
|
7.1%
8/113 • The adverse events presented were collected from start of drug treatment to the end of the treatment period.
The safety analysis is presented on the safety sample meaning the number of patients who were randomized and received at least one dose of study medication.
|
4.7%
5/107 • The adverse events presented were collected from start of drug treatment to the end of the treatment period.
The safety analysis is presented on the safety sample meaning the number of patients who were randomized and received at least one dose of study medication.
|
|
Gastrointestinal disorders
Flatulence Bloating and distension
|
5.3%
6/113 • The adverse events presented were collected from start of drug treatment to the end of the treatment period.
The safety analysis is presented on the safety sample meaning the number of patients who were randomized and received at least one dose of study medication.
|
4.7%
5/107 • The adverse events presented were collected from start of drug treatment to the end of the treatment period.
The safety analysis is presented on the safety sample meaning the number of patients who were randomized and received at least one dose of study medication.
|
|
Infections and infestations
Fungal infection NEC
|
8.0%
9/113 • The adverse events presented were collected from start of drug treatment to the end of the treatment period.
The safety analysis is presented on the safety sample meaning the number of patients who were randomized and received at least one dose of study medication.
|
5.6%
6/107 • The adverse events presented were collected from start of drug treatment to the end of the treatment period.
The safety analysis is presented on the safety sample meaning the number of patients who were randomized and received at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastrointestinal and Abdominal Pains (excl oral and throat)
|
8.0%
9/113 • The adverse events presented were collected from start of drug treatment to the end of the treatment period.
The safety analysis is presented on the safety sample meaning the number of patients who were randomized and received at least one dose of study medication.
|
5.6%
6/107 • The adverse events presented were collected from start of drug treatment to the end of the treatment period.
The safety analysis is presented on the safety sample meaning the number of patients who were randomized and received at least one dose of study medication.
|
|
Nervous system disorders
Headaches NEC
|
11.5%
13/113 • The adverse events presented were collected from start of drug treatment to the end of the treatment period.
The safety analysis is presented on the safety sample meaning the number of patients who were randomized and received at least one dose of study medication.
|
8.4%
9/107 • The adverse events presented were collected from start of drug treatment to the end of the treatment period.
The safety analysis is presented on the safety sample meaning the number of patients who were randomized and received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue signs and symptoms NEC
|
5.3%
6/113 • The adverse events presented were collected from start of drug treatment to the end of the treatment period.
The safety analysis is presented on the safety sample meaning the number of patients who were randomized and received at least one dose of study medication.
|
4.7%
5/107 • The adverse events presented were collected from start of drug treatment to the end of the treatment period.
The safety analysis is presented on the safety sample meaning the number of patients who were randomized and received at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea and Vomiting
|
13.3%
15/113 • The adverse events presented were collected from start of drug treatment to the end of the treatment period.
The safety analysis is presented on the safety sample meaning the number of patients who were randomized and received at least one dose of study medication.
|
8.4%
9/107 • The adverse events presented were collected from start of drug treatment to the end of the treatment period.
The safety analysis is presented on the safety sample meaning the number of patients who were randomized and received at least one dose of study medication.
|
|
Nervous system disorders
Neurological signs and symptoms NEC
|
5.3%
6/113 • The adverse events presented were collected from start of drug treatment to the end of the treatment period.
The safety analysis is presented on the safety sample meaning the number of patients who were randomized and received at least one dose of study medication.
|
7.5%
8/107 • The adverse events presented were collected from start of drug treatment to the end of the treatment period.
The safety analysis is presented on the safety sample meaning the number of patients who were randomized and received at least one dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infections
|
11.5%
13/113 • The adverse events presented were collected from start of drug treatment to the end of the treatment period.
The safety analysis is presented on the safety sample meaning the number of patients who were randomized and received at least one dose of study medication.
|
15.0%
16/107 • The adverse events presented were collected from start of drug treatment to the end of the treatment period.
The safety analysis is presented on the safety sample meaning the number of patients who were randomized and received at least one dose of study medication.
|
Additional Information
Sven Voet - Global Communication
Solvay Pharmaceuticals
Phone: +32(0)2 509 69 77
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Independent analysis and/or publication of these data by the investigator or any member of his/her staff are not permitted without prior written consent of Solvay Pharmaceuticals,Inc. Written permission will be contingent on the review by Solvay Pharmaceuticals, Inc. of the statistical analysis and manuscript and providing for non-disclosure of Solvay Pharmaceuticals, Inc. confidential or proprietary information.
- Publication restrictions are in place
Restriction type: OTHER