CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
Crinone vaginal progesterone gel +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01959464
NCT01959464Phase 4Completed
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Sexual Absorption of Vaginal Progesterone

Wake Forest University Health Sciences·interventional·Posted Oct 10, 2013·Updated Apr 22, 2022

In Brief

A Phase 4 clinical trial evaluating Crinone vaginal progesterone gel and Placebo vaginal gel for Infertility and Pregnancy. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfertility, Pregnancy
CountriesUnited States
CollaboratorsCarolinas Medical Center

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 10, 2013
Enrollment StartNov 1, 2008
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 12.7 years ago

Interventions

Crinone vaginal progesterone geldrug

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

Placebo vaginal geldrug

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