Efficacy of Dapagliflozin Versus Metformin in Polycystic Ovary Syndrome

Phase 3
Recruiting
Conditions
Interventions
Registration Number
NCT06576375
Lead Sponsor
Future University in Egypt
Brief Summary

In PCOS (Polycystic Ovary Syndrome), studies have found impaired incretin secretion and activity, particularly in overweight/obese individuals.
...

Detailed Description

Incretins such as glucagon-like peptide-1(GLP-1) are gut hormones secreted after meals that enhance insulin secretion and help maintain glucose homeostasis.They also reduce hepatic glucagon release, slow gastric emptying, and suppress appetite, aiding in weight control and glycemic management.In PCOS (Polycystic Ovary Syndrome), studies have found impaired i...

Recruitment & Eligibility

Status
RECRUITING
Sex
Female
Target Recruitment
70
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)
Read More
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.
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
DapagliflozinDapagliflozinPatients will receive Dapagliflozin 10 mg once daily orally for 12 weeks (Forxiga® AstraZeneca company)
MetforminMetforminPatients will receive Metformin 1000 mg once daily orally for 12 weeks (control group) (Glucophage® Merck company)
Primary Outcome Measures
NameTimeMethod
Fertility parameters- Luteinizing hormone3-6 months

Luteinizing hormone (LH) in IU/L

Fertility parameters-Free androgen index3-6 months

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

Fertility parameters-Total testosterone3-6 months

Total testosterone in ng/dL

Menstrual diaries3-6 months

Menstruation pattern

Fertility parameters-Follicle-stimulating hormone3-6 months

Follicle-stimulating hormone (FSH) in mIU/mL

Transvaginal ultrasonography3-6 months

disappearance of PCOS

Secondary Outcome Measures
NameTimeMethod
Metabolic parameters3-6 months

Fasting blood glucose (FBG) in mg/dL

Trial Locations

Locations (1)

October 6 University Hospital

🇪🇬

Giza, Egypt

© Copyright 2024. All Rights Reserved by MedPath