CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 5 enrolled
Drug / intervention
Leuprolide acetate +2 moredrug
Likely dose
Leuprolide acetate 11.25mgfrom 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/NCT02969590
NCT02969590Phase 4Completed

Regulation of Cervical Mucus Secretion

Oregon Health and Science University·interventional·Posted Nov 21, 2016·Updated Oct 18, 2019

In Brief

A Phase 4 clinical trial evaluating Leuprolide acetate, Estrogen and Progesterone Replacement, and 1 other intervention for Fertility and Contraception. Completed, enrolled 5 participants across 1 site.

Detailed Summary

The purpose of this study is to help us determine how hormones impact the production of cervical mucus which is a fluid secreted by the opening of the uterus, also called the cervix. During a normal menstrual cycle, cervical mucus changes in response to two hormones that the ovaries make: estrogen and progesterone. Many of the birth control methods women use thicken mucus and make it less likely for sperm to enter the uterus. The goal of this study is to better understand the effects estrogen and progesterone have on the cervical mucus in the body. To do this, the investigators will be using a drug that suppresses natural hormone production for 3 months. Estrogen and progesterone will be artificially replaced to better understand their effects. The investigators will also be studying the effect of a common birth control pill that may work by thickening cervical mucus. Last, the investigators will study some of the cells in the cervix that produce mucus.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 21, 2016
Enrollment StartMar 29, 2015
Primary CompletionAug 23, 2017
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 9.6 years ago

Interventions

Leuprolide acetatedrug

Following this spontaneous cycle, participants received a single intramuscular injection of leuprolide acetate (11.25mg, LupronVR; Abbvie, Chicago, IL), a dose documented to suppress ovarian function for at least 3 months. Ovarian suppression is confirmed with serum E2 less than or equal to 35 pg/ml 21-28 day post-injection.

Estrogen and Progesterone Replacementdrug

Replace hormones exogenously to create an artificial cycle

Progestindrug

Synthetic progestin to assess effects on cervical mucus.