Clinical trial NCT01959464: Sexual Absorption of Vaginal Progesterone
Official title: Sexual Absorption of Vaginal Progesterone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Pregnancy
Keywords: Assisted reproductive technology
Infertility
Progesterone
Vaginal gel
Luteal-phase support
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Carolinas Medical Center
First posted: 2013-10-10
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Initial assignment randomized, then crossed over to the other treatment
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Female Change in Progesterone
timeFrame: 3 weeks
Secondary outcomes:
measure: Male Change in Progesterone
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
Study officials:
affiliation: Carolinas Medical Center
name: Bradley S Hurst, MD
role: PRINCIPAL_INVESTIGATOR
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