Sexual Absorption of Vaginal Progesterone
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies, Infertility |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 40 |
| Updated: | 10/14/2017 |
| Start Date: | November 2008 |
| End Date: | September 2010 |
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.
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.
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.
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
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