Trial Outcomes & Findings for Sexual Absorption of Vaginal Progesterone (NCT NCT01959464)
NCT ID: NCT01959464
Last Updated: 2022-04-22
Results Overview
The primary outcome variables will be: the change in serum progesterone levels increase after coitus in the female partner using vaginal progesterone gel compared to placebo
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
3 weeks
Results posted on
2022-04-22
Participant Flow
Women were enrolled into the study to receive the intervention; male partners also had blood samples taken
Participant milestones
| Measure |
Placebo Vaginal Gel Then Crinone
The couple will be given a prefilled applicator containing placebo vaginal gel, data collection sheets and laboratory requisitions. On the evening of day 3, the female will insert the applicator into the vagina, administer the gel, and have intercourse within 1 hour of insertion of the cream. Then they will be crossed over to Crinone vaginal gel.
|
Crinone Vaginal Progesterone Gel Then Placebo
Crinone is a bioadhesive vaginal gel containing micronized progesterone in an emulsion system containing a water swellable but insoluble polymer, polycarbophil. Crinone 8% is formulated to provide a long-acting vaginal retention, and is prescribed daily. Each applicator delivers 1.125 grams of Crinone gel containing 90 mg of progesterone. The reported time to maximum progesterone concentration is 6.8 +/- 3.3 hours with use of a single dose of Crinone 8%. Absorption half-life is approximately 25-50 hours and an elimination half-life of 5-20 minutes.
On the evening of day 3, the female will insert the applicator into the vagina, administer the Crinone gel, and have intercourse within 1 hour of insertion of the cream. Then subject will cross over to placebo
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sexual Absorption of Vaginal Progesterone
Baseline characteristics by cohort
| Measure |
Crinone Vaginal Progesterone Gel Then Placebo
n=10 Participants
Crinone is a bioadhesive vaginal gel containing micronized progesterone in an emulsion system containing a water swellable but insoluble polymer, polycarbophil. Crinone 8% is formulated to provide a long-acting vaginal retention, and is prescribed daily. Each applicator delivers 1.125 grams of Crinone gel containing 90 mg of progesterone. The reported time to maximum progesterone concentration is 6.8 +/- 3.3 hours with use of a single dose of Crinone 8%. Absorption half-life is approximately 25-50 hours and an elimination half-life of 5-20 minutes.
On the evening of day 3, the female will insert the applicator into the vagina, administer the Crinone gel, and have intercourse within 1 hour of insertion of the cream. Then she will cross over to placebo.
|
Placebo Vaginal Gel Then Crinone
n=10 Participants
The couple will be given a prefilled applicator containing placebo vaginal gel, data collection sheets and laboratory requisitions. On the evening of day 3, the female will insert the applicator into the vagina, administer the gel, and have intercourse within 1 hour of insertion of the cream. Then she will cross over to Crinone.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
10 participants
n=107 Participants
|
20 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 weeksThe primary outcome variables will be: the change in serum progesterone levels increase after coitus in the female partner using vaginal progesterone gel compared to placebo
Outcome measures
| Measure |
Placebo Vaginal Gel
n=20 Participants
The couple will be given a prefilled applicator containing either Crinone gel (progesterone) or placebo vaginal gel, data collection sheets and laboratory requisitions. On the evening of day 3, the female will insert the applicator into the vagina, administer the gel, and have intercourse within 1 hour of insertion of the cream.
Placebo vaginal gel: Placebo vaginal gel is inserted in the female vagina using the pre-filled applicator.
|
Crinone Vaginal Progesterone Gel
n=20 Participants
Crinone is a bioadhesive vaginal gel containing micronized progesterone in an emulsion system containing a water swellable but insoluble polymer, polycarbophil. Crinone 8% is formulated to provide a long-acting vaginal retention, and is prescribed daily. Each applicator delivers 1.125 grams of Crinone gel containing 90 mg of progesterone. The reported time to maximum progesterone concentration is 6.8 +/- 3.3 hours with use of a single dose of Crinone 8%. Absorption half-life is approximately 25-50 hours and an elimination half-life of 5-20 minutes.
On the evening of day 3, the female will insert the applicator into the vagina, administer the gel, and have intercourse within 1 hour of insertion of the cream.
Crinone vaginal progesterone gel: Crinone vaginal progesterone gel is inserted in the female vaginal using the pre-filled applicator.
|
|---|---|---|
|
Female Change in Progesterone
|
0.8 ng/ml
Interval 0.2 to 2.1
|
7.0 ng/ml
Interval 3.5 to 11.9
|
SECONDARY outcome
Timeframe: 3 weeksThe secondary outcome variable will be the change in serum progesterone levels after coitus in the male partner comparing vaginal progesterone gel and placebo.
Outcome measures
| Measure |
Placebo Vaginal Gel
n=20 Participants
The couple will be given a prefilled applicator containing either Crinone gel (progesterone) or placebo vaginal gel, data collection sheets and laboratory requisitions. On the evening of day 3, the female will insert the applicator into the vagina, administer the gel, and have intercourse within 1 hour of insertion of the cream.
Placebo vaginal gel: Placebo vaginal gel is inserted in the female vagina using the pre-filled applicator.
|
Crinone Vaginal Progesterone Gel
n=20 Participants
Crinone is a bioadhesive vaginal gel containing micronized progesterone in an emulsion system containing a water swellable but insoluble polymer, polycarbophil. Crinone 8% is formulated to provide a long-acting vaginal retention, and is prescribed daily. Each applicator delivers 1.125 grams of Crinone gel containing 90 mg of progesterone. The reported time to maximum progesterone concentration is 6.8 +/- 3.3 hours with use of a single dose of Crinone 8%. Absorption half-life is approximately 25-50 hours and an elimination half-life of 5-20 minutes.
On the evening of day 3, the female will insert the applicator into the vagina, administer the gel, and have intercourse within 1 hour of insertion of the cream.
Crinone vaginal progesterone gel: Crinone vaginal progesterone gel is inserted in the female vaginal using the pre-filled applicator.
|
|---|---|---|
|
Male Change in Progesterone
|
0.54 ng/ml
Interval 0.3 to 1.0
|
0.85 ng/ml
Interval 0.2 to 1.8
|
Adverse Events
Placebo Vaginal Gel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Crinone Vaginal Progesterone Gel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Bradley Hurst, M.D., Director of Assisted Reproduction
Carolinas Healthcare System
Phone: 704-355-3149
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place