Efficacy of Dapagliflozin Versus Metformin in Polycystic Ovary Syndrome

NCT06576375 | Recruiting Phase 3 DMC

• 1 other identifier: PRC-Ph-2307003
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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). The study aims to compare the efficacy of Dapagliflozin to Metformin for the treatment of non-diabetic patients with polycystic ovary syndrome (PCOS).

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (6)

• Fertility parameters- Luteinizing hormone

  Luteinizing hormone (LH) in IU/L

  3-6 months

• Fertility parameters-Follicle-stimulating hormone

  Follicle-stimulating hormone (FSH) in mIU/mL

  3-6 months

• Fertility parameters-Free androgen index

  Free androgen index \[ Time Frame: 3-6 months\]

  3-6 months

• Fertility parameters-Total testosterone

  Total testosterone in ng/dL

  3-6 months

• Transvaginal ultrasonography

  disappearance of PCOS

  3-6 months

• Menstrual diaries

  Menstruation pattern

  3-6 months

Secondary Outcomes (1)

• Metabolic parameters

  3-6 months

Study Arms (2)

Dapagliflozin

ACTIVE COMPARATOR

Patients will receive Dapagliflozin 10 mg once daily orally for 12 weeks (Forxiga® AstraZeneca company)

Drug: Dapagliflozin

Metformin

ACTIVE COMPARATOR

Patients will receive Metformin 1000 mg once daily orally for 12 weeks (control group) (Glucophage® Merck company)

Drug: Metformin

Interventions

Dapagliflozin DRUG

oral Dapagliflozin

Dapagliflozin

Metformin DRUG

oral metformin

Metformin

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

• Future University in Egypt: lead
• October 6 University: collaborator

Study Sites (1)

October 6 University Hospital

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

dapagliflozin; Metformin

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Central Study Contacts

Nouran Omar

CONTACT

01006526452; nomar@fue.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Pharmacy Practice & Clinical Pharmacy

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 28, 2024
• Study Start: September 2, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: October 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)