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Diabetes drugs face off in PCOS hormone and metabolism trial

NCT ID NCT05601336

Disease control Sponsor: Beni-Suef University Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Oct 15, 2026 · Last updated Oct 16, 2026 · Updated 1 time

Summary

Researchers compare dapagliflozin, metformin, and a combination of both in 200 women with polycystic ovary syndrome. The trial measures changes in insulin resistance, body weight, blood sugar, testosterone, and cholesterol. It aims to see whether one approach works better than the others for the metabolic and hormonal problems that accompany PCOS.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dapagliflozin, metformin, and their combination
What this could lead to
If the combination works better than either drug alone, it could offer women with PCOS a more effective way to manage insulin resistance, weight, and hormone balance.
What could go wrong
This is a single-center trial, and results may not apply to all women with PCOS. Both drugs can cause side effects like nausea, diarrhea, and urinary infections, and the trial may not show a clear advantage for the combination.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

200 people

The number who actually took part.

Started

May 2025

Finished

May 2026

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 45 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: * Women are aged between 20 and 45 years * polycystic ovarian syndrome (PCOS), according to Rotterdam criteria Exclusion Criteria: 1. congenital adrenal hyperplasia 2. poorly controlled thyroid disease 3. Taking antidiabetic drugs which can affect insulin resistance 4. chronic kidney disease and history of recurrent urinary tract infections 5. liver dysfunction (AST or ALT \> 3 times the upper limit of normal or GFR\<30 ml/min/1.73m2) 6. documented use of oral hormonal contraceptives and hormone-releasing implants

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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.

PCO

Contacts and locations

Locations

  • Beni-suef university

    Banī Suwayf, Beni Suweif Governorate, 62521, Egypt

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