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OpenTrials
Completed

NCT Number: NCT01959464

Sexual Absorption of Vaginal Progesterone

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.

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Key information

Conditions

Infertility Genital Diseases Pregnancy Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Carolinas Medical Center

Charlotte, North Carolina, 28204, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Crinone vaginal progesterone gel

Drug

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

Placebo vaginal gel

Drug

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

Primary outcomes

  1. Female Change in Progesterone

    Time frame: 3 weeks

    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

Secondary outcomes

  1. Male Change in Progesterone

    Time frame: 3 weeks

    The secondary outcome variable will be the change in serum progesterone levels after coitus in the male partner comparing vaginal progesterone gel and placebo.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Carolinas Medical Center

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Oct 10, 2013
Registry last updated
Apr 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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