Regulation of Cervical Mucus Secretion

What Was Tested

In this phase 4 trial, researchers set out to test Leuprolide.

The purpose of this study is to help them 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.

It had three arms (groups): No Intervention: Spontaneous Cycle (1 month) (no intervention), NET Arm - Norethindrone (4 months) (active comparator) and E2WD Arm - Estradiol (4 months) (active comparator).

The registry classes the interventions as drug.

More on the Plan

This proposed study is to evaluate the temporal changes in human cervical mucus in response to progesterone and progestins as an initial step toward clarifying these relationships.

Their hypothesis is that direct effects of progesterone on the endocervix, independent of estrogen withdrawal, cause contraceptive changes to cervical mucus.

To study this, a randomized, prospective, crossover study will be conducted by examining cervical mucus changes in a small cohort of women in whom investigators will suppress circulating hormonal levels by administering a GnRH antagonist.

Investigators will then artificially replace Estrogen and Progesterone in order to differentiate their effects on clinical and laboratory measurements of mucus quality.

Who Took Part

Enrollment: 5 actual participants took part.

It was open to women only aged from 21 years up to 40 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Normal menstrual cycles of 25-35 days in length for at least previous 3 cycles. 21-40 years of age. BMI \>18, \<30. Serum P4 ≥ 3 ng/ml on single sample collected between days 18-25 of self-reported menstrual cycle. Flexible schedule allowing morning blood draws on less than 48 hour notice.

The full record lists 10 inclusion and 17 exclusion criteria; among the exclusions: oral contraceptive use or other hormone supplement within the preceding 2 months; women with current cervical infection; evidence of abnormal cervical cytology.

How the Study Was Run

The set-up was randomized, crossover and single-blind.

Because people in this Leuprolide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the participants took both Leuprolide and the comparison in turn, acting as their own control.

In this single-blind Leuprolide study one party knew the assignments and the other did not.

Those kept unaware of assignments: investigator.

It started in 2015-03-29 with completion listed for 2017-08-23.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Median Cervical Mucus Score - Baseline (time frame: Baseline). Sperm Penetration Scores (time frame: Approximately one year). Median Cervical Mucus Score - 2 Hour (time frame: 2 hours).

It also tracked 1 secondary outcome, for example Change in PGRMC1 During Menstrual Cycle.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Leuprolide in 5 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Leuprolide compound page, all human trials.