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Sexual Absorption of Vaginal Progesterone

NCT01959464 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-04-22

Study results available
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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.

Conditions

Interventions

DRUG

Crinone vaginal progesterone gel

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

DRUG

Placebo vaginal gel

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

Sponsors & Collaborators

  • Carolinas Medical Center

    collaborator OTHER

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Bradley S Hurst, MD · Carolinas Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01959464 on ClinicalTrials.gov