Endometrial Transcript Profile with Progesterone After Post-ovulatory Mifepristone

NCT06616077 | Completed Early Phase 1

• 1 other identifier: RU001
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Endometrial gene expression; Progesterone; Mifepristone; RU486; Secretory endometrium

Outcome Measures

Primary Outcomes (1)

• Endometrial Gene Expression Profile

  RNA-seq gene expression in the midluteal phase

  From enrollment to the end of treatments after aproximately 12 weeks

Secondary Outcomes (1)

• Endometrial dating

  From enrollment to the end of treatments after aproximately 8 months

Other Outcomes (2)

• Uterine ultrasonographic features

  From enrrollment to the end of treatments after 12 weeks

• Circulating progesterone levels

  From enrollment to after the treatments after 12 weeks

Study Arms (4)

Mife + PLA

PLACEBO COMPARATOR

Oral mifepristone 200 mg two days after positive LH (LH+2) and vaginal placebo during LH+3 until LH+5

Drug: mifepristone 200 mg; Drug: Placebo Vaginal

Mife + P4

EXPERIMENTAL

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: Micronized Progesterone 600 mg; Drug: mifepristone 200 mg

PLA + P4

ACTIVE COMPARATOR

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; Drug: Oral Placebo Tablet

PLA + PLA

PLACEBO COMPARATOR

An oral placebo pill two days after positive LH (LH+2) and a vaginal placebo during LH+3 until LH+5

Drug: Oral Placebo Tablet; Drug: Placebo Vaginal

Interventions

Micronized Progesterone 600 mg DRUG

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.

Also known as: Progendo

Mife + P4; PLA + P4

mifepristone 200 mg DRUG

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

Also known as: MIFEAPROFA

Mife + P4; Mife + PLA

Oral Placebo Tablet DRUG

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

PLA + P4; PLA + PLA

Placebo Vaginal DRUG

Cocoa butter

Mife + PLA; PLA + PLA

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Reproductive Health Research Insritute, Chile: lead

Study Sites (1)

Hospital San Borja Arriarán

Santiago, Santiago Metropolitan, 8360160, Chile

Location

MeSH Terms

Interventions

Progesterone; Mifepristone

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones; Estrenes; Estranes

Study Officials

• Alejandro A Tapia-Pizarro, Biologist, PhD

  University of Chile

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 27, 2024
• Study Start: June 7, 2022
• Primary Completion: April 27, 2023
• Study Completion: May 8, 2023
• Last Updated: September 27, 2024

Record last verified: 2024-09

Locations

CL (1)