Sexual Absorption of Vaginal Progesterone

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Atrium Health; Carolinas Healthcare System
• Collaborator: Carolinas Medical Center
• Treatments: Progesterone

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