Efficacy of Dapagliflozin Versus Metformin in Polycystic Ovary Syndrome

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorTanta University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

  • 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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Metformin armActive comparator 1 intervention
Group B: Dapagliflozin armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Fertility parameters- Luteinizing hormone

Measurement of Luteinizing hormone

Time frame
3-months
2

Fertility parameters- Follicle stimulating hormone

Measurment of Luteinizing hormone

Time frame
3-months
3

Fertility parameters-Total testosterone

Measurement of Total testosterone

Time frame
3-months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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