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Endometrial Transcript Profile with Progesterone After Post-ovulatory Mifepristone

NCT06616077 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-09-27

No results posted yet for this study

Summary

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.

Conditions

  • Endometrial Endocrine Regulation
  • Progesterone Supplementation in Women After Mifepristone

Interventions

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.

DRUG

mifepristone 200 mg

Post ovulatory single oral administration (LH+2, LH peak=LH+0)

DRUG

Oral Placebo Tablet

Oral placebo tablet containing brewer yeast, cellulose, stearic acid, silica, magnesium stearate

DRUG

Placebo Vaginal

Cocoa butter

Sponsors & Collaborators

  • Reproductive Health Research Insritute, Chile

    lead OTHER

Principal Investigators

  • Alejandro A Tapia-Pizarro, Biologist, PhD · University of Chile

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2022-06-07
Primary Completion
2023-04-27
Completion
2023-05-08

Countries

  • Chile

Study Locations

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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 NCT06616077 on ClinicalTrials.gov