Dapagliflozin vs Metformin for Polycystic Ovary Syndrome
Efficacy of Dapagliflozin Versus Metformin in Polycystic Ovary Syndrome
Recruiting
Phase 3Interventional Study
Polycystic Ovary Syndrome
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 40
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
70 (estimated)
Sponsor
Future University in Egypt · Other
Who this trial is looking for
This trial is looking for women with polycystic ovary syndrome (PCOS) who are between 18 and 39 years old and experiencing infertility. Participants will be treated with either Dapagliflozin or Metformin to see which is more effective.
Are You a Good Fit for This Trial?
Must not be takingDapagliflozinMetforminThiazolidinedionesGLP-1 receptor agonistsDPP-4 inhibitorsSGLT2 inhibitors
You may be able to join if
I have been diagnosed with polycystic ovary syndrome (PCOS).
I am between 18 and 39 years old.
I am experiencing infertility.
You may not be able to join if
I have a history of diabetes.
I have liver or kidney problems.
I have an inflammatory disease or cancer.
I have had a recent heart event.
I have used certain medications that affect glucose tolerance.
I have a known allergy to dapagliflozin or SGLT2 inhibitors.
I have an eating disorder or gastrointestinal disorder.
I have had bariatric surgery.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
In PCOS (Polycystic Ovary Syndrome), studies have found impaired incretin secretion and activity, particularly in overweight/obese individuals.
Conflicting results exist regarding glucagon-like peptide-1(GLP-1) levels in PCOS patients, with studies reporting reduced, normal, or increased levels. Incretin-based therapy has been suggested as a potential treatment to reverse prediabetes risk by pres…
In PCOS (Polycystic Ovary Syndrome), studies have found impaired incretin secretion and activity, particularly in overweight/obese individuals.
Conflicting results exist regarding glucagon-like peptide-1(GLP-1) levels in PCOS patients, with studies reporting reduced, normal, or increased levels. Incretin-based therapy has been suggested as a potential treatment to reverse prediabetes risk by preserving β-cell function in patients with impaired fasting glucose(IFG and impaired glucose tolerance(IGT). The study aims to compare the efficacy of Dapagliflozin to Metformin for the treatment of non-diabetic patients with polycystic ovary syndrome (PCOS).
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Women diagnosed with PCOS according to Rotterdam 2003 criteria National Institute of Health criteria.
* Age: \>18 \<40 years.
* Infertile women (primary or secondary infertility)
Exclusion Criteria:
* Patients with history of diabetes mellitus (Type 1 or 2).
* Patients with …
Inclusion Criteria:
* Women diagnosed with PCOS according to Rotterdam 2003 criteria National Institute of Health criteria.
* Age: \>18 \<40 years.
* Infertile women (primary or secondary infertility)
Exclusion Criteria:
* Patients with history of diabetes mellitus (Type 1 or 2).
* Patients with liver or renal dysfunction; inflammatory diseases; autoimmune disease; cancer, acute cardiovascular event within last three months and uncontrolled endocrine or metabolic disease.
* Use of hormonal medications, lipid-lowering (statins, etc.), anti-obesity drugs or weight loss medications (prescription or OTC) and medications known to exacerbate glucose tolerance (such as isotretinoin, hormonal contraceptives, glucocorticoids, anabolic steroids) stopped for at least 8 weeks. Use of anti-androgens that act peripherally to reduce hirsutism such as 5-alpha reductase inhibitors stopped for at least 4 weeks.
* Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status.
* Presence of hypersensitivity to dapagliflozin or other Sodium/glucose cotransporter 2 (SGLT2) inhibitors (e.g. anaphylaxis, angioedema, exfoliative skin conditions).
* Use of Metformin, Thiazolidinediones, glucagon-like peptide-1 (GLP-1) receptor agonists, DPP-4 inhibitors, SGLT2 inhibitors
* Eating disorders (anorexia, bulimia) or gastrointestinal disorders.
* Having a history of bariatric surgery.
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