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Can a common diabetes drug help women with PCOS?

NCT ID NCT05802212

Disease control Sponsor: Peking University Third Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how metformin, a diabetes medicine, affects hormone levels in women with polycystic ovary syndrome (PCOS). 77 women aged 20-40 with PCOS took part. Researchers measured changes in key hormones like luteinizing hormone and testosterone after treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

77 people

The number who actually took part.

Started

Jun 2020

Finished

May 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 40 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Individuals who are 20 to 40 years old, planning to become pregnant or infertile women. 2. Individuals who are diagnosed as PCOS according to the revised 2003 Rotterdam diagnostic criteria: if 2 out of 3 criteria are met: 1) Oligo- and/or anovulation; 2) Clinical and/or biochemical signs of hyperandrogenism; 3) Polycystic ovaries, and exclusion of other aetiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome). 3. Individuals who can insist on continuous monitoring in the outpatient clinic. Individuals who are not participating in other research projects currently or 3 months before the intervention. 4. Volunteers with polycystic ovary syndrome without insulin resistance. Exclusion Criteria: 1. Individuals who suffering from other diseases that may cause hyperandrogenism and ovulation abnormalities. 2. Individuals who are during pregnant, lactation or menopause. 3. Individuals who currently receiving weight-loss drugs or surgery or within the past 2 months. 4. Individuals who take niacin, nicotinamide, or other vitamin B3-related supplementation currently or within the past 2 months. 5. Individuals who need regular medication to treat chronic diseases such as diabetes, hypertension, gout, hyperuricemia, etc. 6. Use of medications that affect hormone levels, appetite, carbohydrate absorption, and metabolism within the past 2 months. 7. Individuals with severe liver diseases or kidney disease that are ineligible to participate in the study. 8. A medical history of severe cardiovascular and cerebrovascular diseases. 9. Individuals who currently suffer from severe gastrointestinal diseases or undergo gastrointestinal resection that may affect nutrient absorption. 10. Individuals who drink more than 15g of alcohol per day or have a smoking habit. 11. Individuals who need drug treatment for any mental illness such as epilepsy and depression. 12. Cancer patients. 13. Individuals who suffer from infectious diseases such as hepatitis B, active tuberculosis, AIDS, etc.

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Conditions

The condition(s) this trial relates to.

polycystic ovary syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

PCOS (polycystic ovary syndrome) of bilateral ovaries

Contacts and locations

Locations

  • Peking University Third Hospital

    Beijing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.