Sexual Absorption of Vaginal Progesterone

Phase 4CompletedNCT01959464

Wake Forest University Health Sciences20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

TRIPLE

Enrollment

Conditions

Infertility Pregnancy

Interventions

Crinone vaginal progesterone gelDRUG

Crinone vaginal progesterone gel is inserted in the female vaginal using the pre-filled applicator.

Placebo vaginal gelDRUG

Placebo vaginal gel is inserted in the female vagina using the pre-filled applicator.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Carolinas Medical Center

Charlotte, North Carolina, United States

Outcomes

Primary Outcomes

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

Time frame: 3 weeks

Secondary Outcomes

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.

Time frame: 3 weeks

Data from ClinicalTrials.gov

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