Sexual Absorption of Vaginal Progesterone

Study Overview
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Brief Summary
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The purpose of this study is to determine if sexual intercourse lowers serum progesterone in women using vaginal progesterone gel (Crinone®), and increases serum progesterone in their male sexual partners. We hypothesize, based on previous estrogen studies done by our group, that intercourse will interfere with absorption of vaginal progesterone.

Detailed Description
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The effects of intercourse on the absorption of vaginal progesterone for the female user and her sexual partner have not been studied. However, a previous study performed by our group found that intercourse lowered the absorption of vaginal estrogen cream in women, and men absorbed a small but statistically significant amount of estradiol during intercourse. Vaginal progesterone gel may be used by women for several clinical indications, and if intercourse alters the absorption and distribution of vaginal progesterone, clinical outcomes may be compromised. If intercourse lowers absorption, the efficacy of the treatment could be reduced. If intercourse enhances absorption, side effects may be increased. Also, if the male sexual partner absorbs vaginal progesterone, undesirable side effects may occur.

Official Title
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Sexual Absorption of Vaginal Progesterone

Conditions
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Infertility, Pregnancy

Intervention / Treatment
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* Drug: Crinone vaginal progesterone gel
* Drug: Placebo vaginal gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sexually active 18-40 year old heterosexual couple Subject willing to take Mircette birth control pills for at least one cycle (one pack) Willing to have intercourse at the defined times (at least weekly within a 3 week interval, and draw blood within 10 hours of intercourse) IRB signed informed consent Exclusion Criteria: Undiagnosed vaginal bleeding Contraindication to oral contraceptives Liver dysfunction or disease Known sensitivity to Crinone Known or suspected malignancy of the breast or genital organs History of or active thrombophlebitis or thromboembolic disorders Use of condoms during intercourse Male erectile or ejaculatory dysfunction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Initial assignment randomized, then crossed over to the other treatment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Crinone vaginal progesterone gel<br>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. | Drug: Crinone vaginal progesterone gel<br>* Crinone vaginal progesterone gel is inserted in the female vaginal using the pre-filled applicator.<br>|
| Placebo Comparator: Placebo vaginal gel<br>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. | Drug: Placebo vaginal gel<br>* Placebo vaginal gel is inserted in the female vagina using the pre-filled applicator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Female Change in Progesterone | 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 | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Male Change in Progesterone | The secondary outcome variable will be the change in serum progesterone levels after coitus in the male partner comparing vaginal progesterone gel and placebo. | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Assisted reproductive technology, Infertility, Progesterone, Vaginal gel, Luteal-phase support