Phase 4
Completed N=20
Sexual Absorption of Vaginal Progesterone
Source: ClinicalTrials.gov NCT01959464 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcomePrimary: Female Change in Progesterone — 0.8; 7.0 ng/ml
◆ Published Evidence
Established
40citations · ~4 / year
Sexual absorption of vaginal progesterone: a randomized control trial.
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.
Linked Publications
-
Sexual absorption of vaginal progesterone: a randomized control trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Female Change in Progesterone |
0.8; 7.0 | — |
| SECONDARY Male Change in Progesterone |
0.54; 0.85 | — |
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
Data sourced from ClinicalTrials.gov (NCT01959464) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.