Pretreatment With CPA-EE, Metformin and Myoinositol in PCOS With High AMH

March 30, 2026 updated by: Mst.Sumyara Khatun
Women with PCOS with high AMH randomly allocated into group A & B.Cyproterone acetate plus ethinyl estradiol,metformin & myoinositol in group A and Cyproterone acetate plus ethinyl estradiol & metformin are given in group B.Then letrozole 5 mg day 2 to day 6 is given & ovarian response is seen in day 12 for 3 subsequent 3 months .

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Women with PCOS with high AMH randomly allocated into group A & B.Cyproterone acetate plus ethinyl estradiol once daily ,metformin 500 mg 3 times daily & myoinositol 750 mg 3 times daily for 3 months in group A and Cyproterone acetate plus ethinyl estradiol once daily ,metformin 500 mg 3 times daily are given in group B. .Then letrozole 5 mg day 2 to day 6 is given & ovarian response is seen in day 12 for 3 subsequent 3 months .Ovarian response is seen by day 12 folliculometry -mature follice ,developinf follicle and endometrial thickness and day 21 serum progesterone

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

  • Bangladesh
    • Shahbag
      • Dhaka, Shahbag, Bangladesh, 1000
        • Bangladesh Medical University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • PCOS
  • 18-35 years.
  • Body Mass Index (BMI): 18.5-29.9 kg/m².
  • Infertility.
  • Serum AMH level ≥ 5ng/ml .

Exclusion Criteria:

  • Serum AMH level > 10 ng/ml
  • Endocrine disorder (Hyperprolactinaemia,Uncontrolled hypothyroidism , Diabetes mellitus (DM) type 2,congenital adrenal hyperplasia,cushing syndrome)
  • Any known case of pulmonary,cardiac,hepatic & renal disease
  • Women having metformin or other drug that could influence hormone metabolism at least 3 months before the study
  • Any contraindications to metformin, myoinositol, letrozole & CPA-EE ie. obesity, thromboembolism, breast carcinoma etc & hypersensitivity to these drugs.
  • Women with infertility other than anovulation due to PCOS(bilateral tubal block,uterine factor,endometriosis)
  • Abnormal semen parameter.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental armCyproterone acetate 2 mg plus ethinyl estradiol 35 mcg once daily ,metformin 500 m
Cyproterone acetate 2 mg plus ethinyl estradiol 35 mcg once daily ,metformin 500 mg 3 times daily & Myoinositol 750 mg 3 times daily for 3 months.After 3 months of pretreatment letrozole 5 mg daily for 5 days from day 2 to day 6 of menstrual cycle is given Ovarian response is seen by day 12 folliculometry observing developing follicle ,mature follicle and endometrial thickness and day 21 serum progesterone.
Drug: Cyproterone Acetate, Ethinyl Estradiol Drug Combination
Once daily Cyclically for 3 months
Drug: Metformin 500 mg
Thrice daily for three months
Dietary supplement: Myoinositol 750mg
Thrice daily for three months
Active Comparator: Comparator armCyproterone acetate 2 mg plus ethinyl estradiol 35 mcg once daily ,metformin 500 mg
Cyproterone acetate 2 mg plus ethinyl estradiol 35 mcg once daily ,metformin 500 mg 3 times daily for 3 months.After 3 months of pretreatment letrozole 5 mg daily for 5 days from day 2 to day 6 of menstrual cycle is given Ovarian response is seen by day 12 folliculometry observing developing follicle ,mature follicle and endometrial thickness and day 21 serum progesterone.
Drug: Cyproterone Acetate, Ethinyl Estradiol Drug Combination
Once daily Cyclically for 3 months
Drug: Metformin 500 mg
Thrice daily for three months

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ovarian response by Transvaginal sonography on Day 12-14
Time Frame: 3 months cyclically

Primary outcome variables Ovarian response by Transvaginal sonography on Day 12-14)

Proportion of participants having developing follicles( ≥14 mm) Proportion of participants having mature follicle (18 mm -25 mm) Endometrial thickness (ET)(7 mm or more) Ovulation rate (By mid-luteal serum progesterone 3 ng/ml or more)
3 months cyclically
presence of developing follicle size 14 mm or more ,presence of mature follicle size 14 mm or more and endometrial thickness in day 12 is 7 mm or more folliculometry and day 21 serum progesterone more than 3 ng/mL for 3 months after pretreatment 3 months
Time Frame: presence of developing follicle size 14 mm or more ,presence of mature follicle size 14 mm or more and endometrial thickness in day 12 is 7 mm or more folliculometry and day 21 serum progesterone more than 3 ng/mL for 3 months after pretreatment 3 months
presence of developing follicle size 14 mm or more ,presence of mature follicle size 14 mm or more and endometrial thickness in day 12 is 7 mm or more folliculometry and day 21 serum progesterone more than 3 ng/mL for 3 months after pretreatment 3 months
presence of developing follicle size 14 mm or more ,presence of mature follicle size 14 mm or more and endometrial thickness in day 12 is 7 mm or more folliculometry and day 21 serum progesterone more than 3 ng/mL for 3 months after pretreatment 3 months
Serum progesterone on Day 21
Time Frame: 3 months cyclically
more than 3ng/mL willl be considered as ovulated
3 months cyclically

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pregnancy
Time Frame: 3 months cyclically
Urine pregnancy kit test positive
3 months cyclically

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mst.Sumyara Khatun

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 12, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 12, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 20, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 7, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5159 (Other Identifier: COMITATO ETICO TERRITORIALE LOMBARDIA 3)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on PCOS

Clinical Trials on Cyproterone Acetate, Ethinyl Estradiol Drug Combination

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings