Trial Outcomes & Findings for AMP002 Phase III Contraceptive Study (NCT NCT03243305)
NCT ID: NCT03243305
Last Updated: 2020-09-17
Results Overview
To evaluate the contraceptive efficacy of Amphora over 7-cycle of use
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1384 participants
Primary outcome timeframe
10 months
Results posted on
2020-09-17
Participant Flow
Participant milestones
| Measure |
Interventional
This is a single-arm, open-label, Phase III study of AMPHORA, a non-hormonal contraceptive, at 112 sites in the United States (US) over seven cycles of use in women aged 18 to 35 years who are at risk of pregnancy.
AMPHORA: non-hormonal contraceptive vaginal gel
|
|---|---|
|
Overall Study
STARTED
|
1384
|
|
Overall Study
COMPLETED
|
449
|
|
Overall Study
NOT COMPLETED
|
935
|
Reasons for withdrawal
| Measure |
Interventional
This is a single-arm, open-label, Phase III study of AMPHORA, a non-hormonal contraceptive, at 112 sites in the United States (US) over seven cycles of use in women aged 18 to 35 years who are at risk of pregnancy.
AMPHORA: non-hormonal contraceptive vaginal gel
|
|---|---|
|
Overall Study
Lost to Follow-up
|
250
|
|
Overall Study
Withdrawal by Subject
|
170
|
|
Overall Study
Pregnancy
|
104
|
|
Overall Study
Non-Compliance with Study Drug
|
38
|
|
Overall Study
Adverse Event
|
23
|
|
Overall Study
No sexually active
|
26
|
|
Overall Study
Physician Decision
|
22
|
|
Overall Study
Protocol Violation
|
22
|
|
Overall Study
Study method no longer primary method
|
12
|
|
Overall Study
Study Terminated by Sponsor
|
1
|
|
Overall Study
Early terminations
|
267
|
Baseline Characteristics
AMP002 Phase III Contraceptive Study
Baseline characteristics by cohort
| Measure |
Interventional
n=1384 Participants
This is a single-arm, open-label, Phase III study of AMPHORA, a non-hormonal contraceptive, at 112 sites in the United States (US) over seven cycles of use in women aged 18 to 35 years who are at risk of pregnancy.
AMPHORA: non-hormonal contraceptive vaginal gel
|
|---|---|
|
Age, Continuous
|
27.7 years
STANDARD_DEVIATION 4.49 • n=99 Participants
|
|
Sex: Female, Male
Female
|
1384 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
571 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
805 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
35 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
348 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
955 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
38 Participants
n=99 Participants
|
|
Body Mass Index (BMI) at Screening
|
28.770 kg/m^2
STANDARD_DEVIATION 8.1079 • n=99 Participants
|
PRIMARY outcome
Timeframe: 10 monthsPopulation: MITT population that included only those subjects whose diaries indicated that they used the study drug correctly for every act of intercourse for at least 1 menstrual cycle. Cycles in which the study drug was used incorrectly for 1 or more coital acts were removed, and the remaining cycles were aligned in order to provide contiguous cycles.
To evaluate the contraceptive efficacy of Amphora over 7-cycle of use
Outcome measures
| Measure |
Interventional
n=1182 Participants
This is a single-arm, open-label, Phase III study of AMPHORA, a non-hormonal contraceptive, at 112 sites in the United States (US) over seven cycles of use in women aged 18 to 35 years who are at risk of pregnancy.
AMPHORA: non-hormonal contraceptive vaginal gel
|
|---|---|
|
Number of Subjects With Pregnancy Outcomes to Measure Contraceptive Efficacy
|
100 Participants
|
SECONDARY outcome
Timeframe: 10 monthsPopulation: All subjects enrolled into the study and who administered the study drug at least once.
Incidence of AE to evaluate safety
Outcome measures
| Measure |
Interventional
n=1330 Participants
This is a single-arm, open-label, Phase III study of AMPHORA, a non-hormonal contraceptive, at 112 sites in the United States (US) over seven cycles of use in women aged 18 to 35 years who are at risk of pregnancy.
AMPHORA: non-hormonal contraceptive vaginal gel
|
|---|---|
|
Number of Subjects With Adverse Events (AE)
Subjects with greater than or equal to 1 AE
|
601 Participants
|
|
Number of Subjects With Adverse Events (AE)
Subjects with greater than or equal to 1 SAE
|
17 Participants
|
|
Number of Subjects With Adverse Events (AE)
AE leading to early discontinuation
|
25 Participants
|
|
Number of Subjects With Adverse Events (AE)
Relationship of AEs: unlikely to be Related
|
186 Participants
|
|
Number of Subjects With Adverse Events (AE)
Relationship of AEs: possibly related
|
166 Participants
|
|
Number of Subjects With Adverse Events (AE)
Relationship of AEs: probably related
|
139 Participants
|
|
Number of Subjects With Adverse Events (AE)
Relationship of AEs: definitely related
|
108 Participants
|
|
Number of Subjects With Adverse Events (AE)
Relationship of AEs: not assessable
|
2 Participants
|
|
Number of Subjects With Adverse Events (AE)
Intensity of AEs: mild
|
318 Participants
|
|
Number of Subjects With Adverse Events (AE)
Intensity of AEs: moderate
|
249 Participants
|
|
Number of Subjects With Adverse Events (AE)
Intensity of AEs: severe
|
31 Participants
|
|
Number of Subjects With Adverse Events (AE)
Intensity of AEs: life-threatening
|
3 Participants
|
|
Number of Subjects With Adverse Events (AE)
Death
|
0 Participants
|
Adverse Events
Interventional
Serious events: 17 serious events
Other events: 601 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Interventional
n=1330 participants at risk
This is a single-arm, open-label, Phase III study of AMPHORA, a non-hormonal contraceptive, at 112 sites in the United States (US) over seven cycles of use in women aged 18 to 35 years who are at risk of pregnancy.
AMPHORA: non-hormonal contraceptive vaginal gel
|
|---|---|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.08%
1/1330 • 10 months
An AE was defined as any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not it is considered related.
|
|
Gastrointestinal disorders
Vomiting
|
0.08%
1/1330 • 10 months
An AE was defined as any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not it is considered related.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.08%
1/1330 • 10 months
An AE was defined as any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not it is considered related.
|
|
Infections and infestations
Cystitis
|
0.08%
1/1330 • 10 months
An AE was defined as any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not it is considered related.
|
|
Infections and infestations
Pneumonia
|
0.08%
1/1330 • 10 months
An AE was defined as any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not it is considered related.
|
|
Infections and infestations
Sepsis
|
0.08%
1/1330 • 10 months
An AE was defined as any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not it is considered related.
|
|
Injury, poisoning and procedural complications
Uterine rupture
|
0.15%
2/1330 • 10 months
An AE was defined as any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not it is considered related.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.08%
1/1330 • 10 months
An AE was defined as any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not it is considered related.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.08%
1/1330 • 10 months
An AE was defined as any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not it is considered related.
|
|
Nervous system disorders
Status epilepticus
|
0.08%
1/1330 • 10 months
An AE was defined as any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not it is considered related.
|
|
Pregnancy, puerperium and perinatal conditions
Premature separation of placenta
|
0.08%
1/1330 • 10 months
An AE was defined as any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not it is considered related.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.08%
1/1330 • 10 months
An AE was defined as any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not it is considered related.
|
|
Psychiatric disorders
Bipolar I disorder
|
0.08%
1/1330 • 10 months
An AE was defined as any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not it is considered related.
|
|
Psychiatric disorders
Depression suicidal
|
0.08%
1/1330 • 10 months
An AE was defined as any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not it is considered related.
|
|
Reproductive system and breast disorders
Vaginal disorder
|
0.08%
1/1330 • 10 months
An AE was defined as any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not it is considered related.
|
|
Pregnancy, puerperium and perinatal conditions
Trisomy 21
|
0.08%
1/1330 • 10 months
An AE was defined as any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not it is considered related.
|
|
Pregnancy, puerperium and perinatal conditions
Preeclampsia
|
0.08%
1/1330 • 10 months
An AE was defined as any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not it is considered related.
|
|
Pregnancy, puerperium and perinatal conditions
Premature rupture of membrane
|
0.08%
1/1330 • 10 months
An AE was defined as any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not it is considered related.
|
Other adverse events
| Measure |
Interventional
n=1330 participants at risk
This is a single-arm, open-label, Phase III study of AMPHORA, a non-hormonal contraceptive, at 112 sites in the United States (US) over seven cycles of use in women aged 18 to 35 years who are at risk of pregnancy.
AMPHORA: non-hormonal contraceptive vaginal gel
|
|---|---|
|
Infections and infestations
Bacterial vaginosis
|
2.8%
37/1330 • 10 months
An AE was defined as any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not it is considered related.
|
|
Infections and infestations
Nasopharyngitis
|
2.6%
35/1330 • 10 months
An AE was defined as any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not it is considered related.
|
|
Infections and infestations
Urinary tract infection
|
5.7%
76/1330 • 10 months
An AE was defined as any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not it is considered related.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
2.9%
38/1330 • 10 months
An AE was defined as any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not it is considered related.
|
|
Reproductive system and breast disorders
Vulvovaginal burning sensation
|
20.0%
266/1330 • 10 months
An AE was defined as any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not it is considered related.
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
3.8%
51/1330 • 10 months
An AE was defined as any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not it is considered related.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
11.2%
149/1330 • 10 months
An AE was defined as any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not it is considered related.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60