Endometrial Endocrine RegulationEarly Phase 1NCT06616077
Endometrial Transcript Profile with Progesterone After Post-ovulatory Mifepristone
A Early Phase 1 study testing Micronized Progesterone 600 mg and mifepristone 200 mg in people with Endometrial Endocrine Regulation and Progesterone Supplementation in Women After Mifepristone, run by Reproductive Health Research Insritute, Chile at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Endocrine Regulation, Progesterone Supplementation in Women After Mifepristone
- What is being tested?
- Micronized Progesterone 600 mg and mifepristone 200 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteChile
- Study dates
- 7 Jun 2022to 8 May 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- proven fertility
- regular menstrual cycles
- surgically sterilized at least one year before participating in the protocol
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Chile1 site
Hospital San Borja Arriarán
Santiago, Santiago Metropolitan, 8360160
About this study
Official title: 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?
Read more
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.
Read the 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.
- Conditions
- Endometrial Endocrine Regulation, Progesterone Supplementation in Women After Mifepristone
- Being tested
- Micronized Progesterone 600 mg, mifepristone 200 mg, Oral Placebo Tablet, Placebo Vaginal
- Keywords
- Endometrial gene expression, Progesterone, Mifepristone, RU486, Secretory endometrium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micronized Progesterone 600 mgDrug
Also called Progendo
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.
mifepristone 200 mgDrug
Also called MIFEAPROFA
Post ovulatory single oral administration (LH+2, LH peak=LH+0)
Oral Placebo TabletDrug
Oral placebo tablet containing brewer yeast, cellulose, stearic acid, silica, magnesium stearate
Placebo VaginalDrug
Cocoa butter
| Study group | Role | What they receive |
|---|---|---|
| Mife + PLA | Placebo comparator | Oral mifepristone 200 mg two days after positive LH (LH+2) and vaginal placebo during LH+3 until LH+5 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Oral Placebo Tablet; Drug: Placebo Vaginal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrial Gene Expression Profile
RNA-seq gene expression in the midluteal phase
Measured: From enrollment to the end of treatments after aproximately 12 weeks
Secondary outcomes (1)
Endometrial dating
Estimated cycle day based on endometrial morphology according to the Noyes criteria
Measured: From enrollment to the end of treatments after aproximately 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start7 Jun 2022
- Primary completion27 Apr 2023
- Study completion8 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial Endocrine RegulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reproductive Health Research Insritute, Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alejandro A Tapia-Pizarro, Biologist, PhD, Study director, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616077
- Sponsor's protocol ID
- RU001
- Status last verified
- Sep 2024
- First submitted
- 17 Sep 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinaton of Changes in the Endometrial Gene Expression Profile Induced by Exogenous Progesterone After Post-ovulatory Administration of Mifepristone
- ClinicalTrials.gov ID
- NCT06616077
- Acronym / sponsor ID
- RU001
- Conditions
- Endometrial Endocrine Regulation, Progesterone Supplementation in Women After Mifepristone
- Keywords
- Endometrial gene expression, Progesterone, Mifepristone, RU486, Secretory endometrium
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Reproductive Health Research Insritute, ChileUniversity, hospital or other
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 27 Apr 2023 (actual)
- Study completion
- 8 May 2023 (actual)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mife + PLA | Placebo comparator | Drug: mifepristone 200 mg, Drug: Placebo VaginalOral mifepristone 200 mg two days after positive LH (LH+2) and vaginal placebo during LH+3 until LH+5 |
| Mife + P4 | Experimental | Drug: Micronized Progesterone 600 mg, Drug: mifepristone 200 mgOral mifepristone 200 mg two days after positive LH (LH+2) and vaginal micronized progesterone (600 mg/day) during LH+3 until LH+5 |
| PLA + P4 | Active comparator | Drug: Micronized Progesterone 600 mg, Drug: Oral Placebo TabletAn oral placebo pill two days after positive LH (LH+2) and vaginal micronized progesterone (600 mg/day) during LH+3 until LH+5 |
| PLA + PLA | Placebo comparator | Drug: Oral Placebo Tablet, Drug: Placebo VaginalAn oral placebo pill two days after positive LH (LH+2) and a vaginal placebo during LH+3 until LH+5 |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- proven fertility
- regular menstrual cycles
- surgically sterilized at least one year before participating in the protocol
Key exclusion criteria (6 listed)
- chronic medical problems
- abnormal results of screening blood tests
- ovarian masses
- symptomatic endometriosis
- uterine leiomyomata
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micronized Progesterone 600 mgAlso: ProgendoVaginal 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 | Mife + P4, PLA + P4 |
| mifepristone 200 mgAlso: MIFEAPROFAPost ovulatory single oral administration (LH+2, LH peak=LH+0) | Drug | Mife + P4, Mife + PLA |
| Oral Placebo TabletOral placebo tablet containing brewer yeast, cellulose, stearic acid, silica, magnesium stearate | Drug | PLA + P4, PLA + PLA |
| Placebo VaginalCocoa butter | Drug | Mife + PLA, PLA + PLA |
Primary outcome
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
1 secondary outcome
Endometrial dating
Time frame: From enrollment to the end of treatments after aproximately 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandro A Tapia-Pizarro, Biologist, PhD study director
University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Micronized Progesterone 600 mg and mifepristone 200 mg in people with Endometrial Endocrine Regulation and Progesterone Supplementation in Women After Mifepristone, run by Reproductive Health Research Insritute, Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometrial Gene Expression Profile (time frame: From enrollment to the end of treatments after aproximately 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.