NCT06140108CompletedPhase 2/3
Empagliflozin vs Metformin on Metabolic Dysfunction in Polycystic Ovary Syndrome With or Without Comorbidity or Multimorbidity
Comparing the Effects of Empagliflozin and Metformin on Metabolic Dysfunction in Polycystic Ovary Syndrome With or Without Comorbidity or Multimorbidity
Source: ClinicalTrials.gov · Last updated 14 May 2025
Brief summary (registry, in English)
this is open labelled randomize control trial among women with PCOS. PCOS, an endocrine condition, affects 5%-15% of premenopausal women. PCOS is characterized by atypical menstruation, ovulation difficulties, hyperandrogenemia, insulin resistance, and other metabolic abnormalities. Metformin is now an option for PCOS. The clinical reactions to metformin are limited and varied. Novel SGLT2 inhibitors treat type 2 diabetes with weight loss, insulin resistance reduction, and cardiovascular benefits. There is little evidence on SGLT2 inhibitor effectiveness in PCOS patients.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 70 (actual)
- First submitted
- 7 Nov 2023
- Start date
- 15 Dec 2023
- Primary completion date
- 30 May 2024
- Lead sponsor
- SINA Health Education and Welfare Trust
- NCT number
- NCT06140108
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 70
- From 15 Dec 2023 to the primary completion date, 30 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- In addition to this, Pregnancy or intent to become pregnant, breastfeeding, documented use of oral hormonal contraceptives and hormone- releasing implants, clomiphene citrate or oestrogen modulators, gonadotropin-releasing hormone (GnRH) modulators and Minoxidil will be excluded.
Other illness
- Women of non-classical 21-hydroxylase deficiency, hyperprolactinemia, Cushing's disease, or androgen- secreting tumors will be streaked from participating.
- History or presence of malignant neoplasms within the last one years, pancreatitis (acute or chronic) will also be excluded from the study
- Women with recurrent complaint of urinary tract infection (UTI)will be excluded from the study.
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Who the study is looking for
- All women participants belong to the reproductive age group, i.e., 18 to 45 years will be included in the study.
- All those women of BMI of greater than 25 kg/m2 will be included in this study
- Women with a diagnosis of PCOS by using two (hyperandrogenism and oligo-anovulation) out of three (oligo-anovulation, hyperandrogenism and polycystic ovaries) Rotterdam criteria 2 which confirm hyperandrogenism (acne, seborrhea, hair loss on the scalp, increased body or facial hair) on clinical judgement will be included in the study
- Those who documented and self-reported oligomenorrhea (cycle length greater than 35 days and nine or fewer periods per year) will be included. or
- Those who report amenorrhea (absence of menses for a period of 3 months) will be inclusion criteria of the study.
- 6- PCO Women with or without comorbidity or Multimorbidity specifically, Hypothyroidism, Diabetes, Hypertension.
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Age in the registry: 15 years to 49 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SINA Yousuf Sb Goth Coordinator of this site? Confirm its status | Karachi | Pakistan | Unknown status |
Related publications
- Comparative effects of empagliflozin and metformin on metabolic dysfunction in polycystic ovary syndrome, a double blinded randomized control feasibility trial.BMC Womens Health · 2025 · PMID 41257673
This page is information, not medical advice. Discuss any trial with your doctor.