Health TrialsbyHealthPanel

Efficacy of Dapagliflozin Versus Metformin in Polycystic Ovary Syndrome

ConditionPolycystic Ovary Syndrome
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorFuture University in Egypt

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women diagnosed with PCOS according to Rotterdam 2003 criteria National Institute of Health criteria.

Age: >18 <40 years.

Infertile women (primary or secondary infertility)

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dapagliflozin

    Drug

    oral Dapagliflozin

  • Metformin

    Drug

    oral metformin

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: DapagliflozinActive comparator 1 intervention
Group B: MetforminActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Fertility parameters- Luteinizing hormone

Luteinizing hormone (LH) in IU/L

Time frame
3-6 months
2

Fertility parameters-Follicle-stimulating hormone

Follicle-stimulating hormone (FSH) in mIU/mL

Time frame
3-6 months
3

Fertility parameters-Free androgen index

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

Time frame
3-6 months
4

Fertility parameters-Total testosterone

Total testosterone in ng/dL

Time frame
3-6 months

Secondary outcomes

1

Metabolic parameters

Fasting blood glucose (FBG) in mg/dL

Time frame
3-6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Future University in Egypt

Lead sponsor

October 6 University

Collaborator

Source ClinicalTrials.gov
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