Endometrial Transcript Profile with Progesterone After Post-ovulatory Mifepristone

September 24, 2024 updated by: Reproductive Health Research Insritute, Chile

Determinaton of Changes in the Endometrial Gene Expression Profile Induced by Exogenous Progesterone After Post-ovulatory Administration of Mifepristone

The goal of this exploratory trial is to determine the endometrial gene expression profile induced by exogenous progesterone after postovulatory administration of mifepristone. It will also learn about the plasticity ofr the endometrial response to progesterone. The main questions it aims to answer are:

Is exogenous progesterone able to modulate the gene expression of endometrial transcripts that have been altered by mifepristone?

Researchers will compare the endometrial gene expression profiles with exogeonous progesterone to a placebo (a look-alike substance that contains no drug) after postovulatory administration of mifepristone.

Participants will:

Do ovulation follow-up tests at home assesing LH in urine Visit the hospital 2 days after a positive LH for mifepristone administration and ultrasonography check of ovaries and uterus.

Starting from the next day, take progesterone or placebo for 3 days. Visit the hospital 2 days after that for ultrasonography check of ovaries and uterus and for an endometrial and blood sample collection.

The endometrial samples will be processed to isolate the RNA and for histological assessment. Gene expression profiles will be determined by RNA-seq.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objective: To determine the effect of progesterone supplementation on the mid-secretory endometrial transcript profile after postovulatory administration of mifepristone.

Design: A randomized, double-blind, placebo-controlled study. Setting: Tertiary academic medical center Subjects: A total of 9 Hispanic women of proven fertility who had been surgically sterilized.

Interventions: Participating women received a single dose of mifepristone 200mg 48 hours after the LH peak (LH+2, LH+0=LH peak). Endometrial samples were obtained on LH+7 after vaginal administration of micronized progesterone (600mg/day) for 3 days (LH+3 to LH+5). Each woman contributed with one cycle treated with placebo and another with progesterone (group A). Additionally, endometrial samples were obtained on LH+7 from subset of 4 women who did not receive mifepristone; with each one contributing with one cycle treated with vaginal progesterone supplementation or placebo as a reference (group B). Endometrial thickness, circulating progesterone levels, and endometrial histology were also documented in all cycles. RNA-seq was used to identify genes whose transcript levels significantly changed by the administration of progesterone versus placebo, with postovulatory administration of mifepristone. The transcript profiles of these genes were further evaluated in the endometrial samples from group B.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Región Metropolitana
      • Santiago, Región Metropolitana, Chile, 8360160
        • Hospital San Borja Arriarán

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • proven fertility
  • regular menstrual cycles
  • surgically sterilized at least one year before participating in the protocol

Exclusion Criteria:

  • chronic medical problems
  • abnormal results of screening blood tests
  • ovarian masses
  • symptomatic endometriosis
  • uterine leiomyomata
  • being under chronic medication or taking hormones or drugs able to modify the metabolism of steroid hormones in the 3 preceding months to study enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Mife + PLA
Oral mifepristone 200 mg two days after positive LH (LH+2) and vaginal placebo during LH+3 until LH+5
Drug: mifepristone 200 mg
Post ovulatory single oral administration (LH+2, LH peak=LH+0)
Other Names:
  • MIFEAPROFA
Drug: Placebo Vaginal
Cocoa butter
Experimental: Mife + P4
Oral mifepristone 200 mg two days after positive LH (LH+2) and vaginal micronized progesterone (600 mg/day) during LH+3 until LH+5
Drug: mifepristone 200 mg
Post ovulatory single oral administration (LH+2, LH peak=LH+0)
Other Names:
  • MIFEAPROFA
Drug: Micronized Progesterone 600 mg
Vaginal supplementary micronized progesterone will be given after postovulatory administration of the progesterone receptor antagonist mifepristone. Administration from LH+3 to LH+5 (LH peak=LH+0); 200 mg 3 times per day.
Other Names:
  • Progendo
Active Comparator: PLA + P4
An oral placebo pill two days after positive LH (LH+2) and vaginal micronized progesterone (600 mg/day) during LH+3 until LH+5
Drug: Micronized Progesterone 600 mg
Vaginal supplementary micronized progesterone will be given after postovulatory administration of the progesterone receptor antagonist mifepristone. Administration from LH+3 to LH+5 (LH peak=LH+0); 200 mg 3 times per day.
Other Names:
  • Progendo
Drug: Oral Placebo Tablet
Oral placebo tablet containing brewer yeast, cellulose, stearic acid, silica, magnesium stearate
Placebo Comparator: PLA + PLA
An oral placebo pill two days after positive LH (LH+2) and a vaginal placebo during LH+3 until LH+5
Drug: Placebo Vaginal
Cocoa butter
Drug: Oral Placebo Tablet
Oral placebo tablet containing brewer yeast, cellulose, stearic acid, silica, magnesium stearate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endometrial Gene Expression Profile
Time Frame: From enrollment to the end of treatments after aproximately 12 weeks
RNA-seq gene expression in the midluteal phase
From enrollment to the end of treatments after aproximately 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endometrial dating
Time Frame: From enrollment to the end of treatments after aproximately 8 months
Estimated cycle day based on endometrial morphology according to the Noyes criteria
From enrollment to the end of treatments after aproximately 8 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uterine ultrasonographic features
Time Frame: From enrrollment to the end of treatments after 12 weeks
Will be evaluated the ultrasonographic features such as hypo- and hyper- echogenecity
From enrrollment to the end of treatments after 12 weeks
Circulating progesterone levels
Time Frame: From enrollment to after the treatments after 12 weeks
Will be evaluated the cirduating levels of progesterone on day LH+7 (LH+0=LH peak) in women that have taken postovulatory mifepristone plus exogenous progesterone or placebo.
From enrollment to after the treatments after 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Reproductive Health Research Insritute, Chile

Investigators

  • Study Director: Alejandro A Tapia-Pizarro, Biologist, PhD, University of Chile

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2022

Primary Completion (Actual)

April 27, 2023

Study Completion (Actual)

May 8, 2023

Study Registration Dates

First Submitted

September 17, 2024

First Submitted That Met QC Criteria

September 24, 2024

First Posted (Actual)

September 27, 2024

Study Record Updates

Last Update Posted (Actual)

September 27, 2024

Last Update Submitted That Met QC Criteria

September 24, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RU001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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