Efficacy of Dapagliflozin Versus Metformin in Polycystic Ovary Syndrome

NCT07810998 | Not Yet Recruiting Phase 2

• 1 other identifier: KN-178
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Poly Cystic Ovary Syndrome

Outcome Measures

Primary Outcomes (3)

• Fertility parameters- Luteinizing hormone

  Measurement of Luteinizing hormone

  3-months

• Fertility parameters- Follicle stimulating hormone

  Measurment of Luteinizing hormone

  3-months

• Fertility parameters-Total testosterone

  Measurement of Total testosterone

  3-months

Study Arms (2)

Metformin arm

ACTIVE COMPARATOR

Patients will receive Metformin 1000 mg once daily orally for 12 weeks

Drug: Metformin

Dapagliflozin arm

ACTIVE COMPARATOR

Patients will receive Dapagliflozin 10 mg once daily orally for 12 weeks

Drug: Dapagliflozin (10mg Tab)

Interventions

Metformin DRUG

Metformin is a widely used insulin-sensitizing agent and one of the most established pharmacological treatments for the metabolic abnormalities associated with polycystic ovary syndrome (PCOS).

Metformin arm

Dapagliflozin (10mg Tab) DRUG

Dapagliflozin is a sodium-glucose cotransporter-2 (SGLT2) inhibitor that promotes urinary glucose and sodium excretion by reducing renal glucose reabsorption. Beyond its established role in type 2 diabetes, dapagliflozin has attracted interest as a potential therapeutic option for polycystic ovary syndrome

Dapagliflozin arm

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women diagnosed with PCOS according to Rotterdam 2003 criteria National Institute of Health criteria.
• Age: \>18 \<40 years. Infertile women (primary or secondary infertility)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

MeSH Terms

Interventions

Metformin; dapagliflozin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Central Study Contacts

Mostafa M Bahaa, PhD

CONTACT

01025538337; mbahaa@horus.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 9, 2026
• Study Start: September 10, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): May 10, 2027
• Last Updated: September 9, 2026

Record last verified: 2026-09