PCOSNCT07513480

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

A study testing Cyproterone Acetate, Ethinyl Estradiol Drug Combination, Metformin 500 mg and Myoinositol 750mg in people with PCOS, run by Mst.Sumyara Khatun at 1 site in Bangladesh.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 18 to 35 years, women only
Conditions the study is for: PCOS
What is being tested?: Cyproterone Acetate, Ethinyl Estradiol Drug Combination, Metformin 500 mg and Myoinositol 750mg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 68 participants
Where: 1 siteBangladesh
Study dates: 12 Aug 2024to 20 Feb 2026
Phase: Interventional
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 35 years
Women only
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site

Bangladesh Medical University
Dhaka, Shahbag, 1000

Other trials in Bangladesh

About this study

Read the 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

Conditions: PCOS
Being tested: Cyproterone Acetate, Ethinyl Estradiol Drug Combination, Metformin 500 mg, Myoinositol 750mg
Keywords: PCOS ovarian response

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cyproterone Acetate, Ethinyl Estradiol Drug CombinationDrug
Once daily Cyclically for 3 months
Metformin 500 mgDrug
Thrice daily for three months
Myoinositol 750mgDietary supplement
Thrice daily for three months

Study groups in NCT07513480
Study group	Role	What they receive
Experimental armCyproterone acetate 2 mg plus ethinyl estradiol 35 mcg once daily ,metformin 500 m	Experimental	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. Receives: Drug: Cyproterone Acetate, Ethinyl Estradiol Drug Combination; Drug: Metformin 500 mg; Dietary Supplement: Myoinositol 750mg
Comparator armCyproterone acetate 2 mg plus ethinyl estradiol 35 mcg once daily ,metformin 500 mg	Active comparator	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. Receives: Drug: Cyproterone Acetate, Ethinyl Estradiol Drug Combination; Drug: Metformin 500 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Ovarian response by Transvaginal sonography on Day 12-14
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)
Measured: 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
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
Measured: 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
more than 3ng/mL willl be considered as ovulated
Measured: 3 months cyclically

Secondary outcomes (1)

Pregnancy
Urine pregnancy kit test positive
Measured: 3 months cyclically

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Aug 202420 Feb 2026

First posted7 Apr 2026
Study start12 Aug 2024
Primary completion12 Nov 2025
Study completion20 Feb 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PCOSStudies 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: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: open label parallel design randomized controlled trial
Masking: None (open label)
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07513480
Sponsor's protocol ID: 5159
Status last verified: Feb 2026
First submitted: 2 Mar 2026
Last updated: 7 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)

All PCOS trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pretreatment With CPA-EE, Metformin and Myoinositol in PCOS With High AMH
ClinicalTrials.gov ID: NCT07513480
Acronym / sponsor ID: 5159
Conditions: PCOS
Keywords: PCOS ovarian response
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Mst.Sumyara KhatunUniversity, hospital or other
Study start: 12 Aug 2024 (actual)
Primary completion: 12 Nov 2025 (actual)
Study completion: 20 Feb 2026 (actual)
First posted: 7 Apr 2026 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: open label parallel design randomized controlled trial

Arm	Type	Receives
Experimental armCyproterone acetate 2 mg plus ethinyl estradiol 35 mcg once daily ,metformin 500 m	Experimental	Drug: Cyproterone Acetate, Ethinyl Estradiol Drug Combination, Drug: Metformin 500 mg, Dietary Supplement: Myoinositol 750mgCyproterone 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.
Comparator armCyproterone acetate 2 mg plus ethinyl estradiol 35 mcg once daily ,metformin 500 mg	Active comparator	Drug: Cyproterone Acetate, Ethinyl Estradiol Drug Combination, Drug: Metformin 500 mgCyproterone 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.

Who may qualify

Ages: 18 to 35 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (7 listed)

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.

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
Cyproterone Acetate, Ethinyl Estradiol Drug CombinationOnce daily Cyclically for 3 months	Drug	Comparator armCyproterone acetate 2 mg plus ethinyl estradiol 35 mcg once daily ,metformin 500 mg, Experimental armCyproterone acetate 2 mg plus ethinyl estradiol 35 mcg once daily ,metformin 500 m
Metformin 500 mgThrice daily for three months	Drug	Comparator armCyproterone acetate 2 mg plus ethinyl estradiol 35 mcg once daily ,metformin 500 mg, Experimental armCyproterone acetate 2 mg plus ethinyl estradiol 35 mcg once daily ,metformin 500 m
Myoinositol 750mgThrice daily for three months	Dietary supplement	Experimental armCyproterone acetate 2 mg plus ethinyl estradiol 35 mcg once daily ,metformin 500 m

Primary outcome

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)
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
Serum progesterone on Day 21
Time frame: 3 months cyclically
more than 3ng/mL willl be considered as ovulated

1 secondary outcome

Pregnancy
Time frame: 3 months cyclically

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 7 Apr 2026.
Individual participant dataSharing planned: No

Related trials for PCOS

Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Cyproterone Acetate, Ethinyl Estradiol Drug Combination, Metformin 500 mg and Myoinositol 750mg in people with PCOS, run by Mst.Sumyara Khatun at 1 site in Bangladesh.

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 5 inclusion and 7 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 7 Apr 2026. 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 Bangladesh. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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?

Ovarian response by Transvaginal sonography on Day 12-14 (time frame: 3 months cyclically). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07513480.

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 7 Apr 2026.