An Early Phase 1 interventional study of Micronized Progesterone 600 mg and mifepristone 200 mg in Endometrial Endocrine Regulation and Progesterone Supplementation in Women After Mifepristone, sponsored by Reproductive Health Research Insritute, Chile. Completed at 1 site in Chile. Open to female participants aged 18 Years to 43 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-27.
Sponsored by Reproductive Health Research Insritute, Chile · Early Phase 1, Interventional, and Basic science
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.
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.
This is the only study on the registry with Reproductive Health Research Insritute, Chile as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
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
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
Post ovulatory single oral administration (LH+2, LH peak=LH+0)
Also known as: MIFEAPROFA
Oral placebo tablet containing brewer yeast, cellulose, stearic acid, silica, magnesium stearate
Cocoa butter
Endometrial Gene Expression Profile
RNA-seq gene expression in the midluteal phase
Time frame: From enrollment to the end of treatments after aproximately 12 weeks
Endometrial dating
Estimated cycle day based on endometrial morphology according to the Noyes criteria
Time frame: From enrollment to the end of treatments after aproximately 8 months
Uterine ultrasonographic features
Will be evaluated the ultrasonographic features such as hypo- and hyper- echogenecity
Time frame: From enrrollment to the end of treatments after 12 weeks
Circulating progesterone levels
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.
Time frame: From enrollment to after the treatments after 12 weeks
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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