NCT06405178CompletedPhase 3
Adjuvant Therapy With Letrozole in Induction of Ovulation With Polycystic Ovarian Syndrome
Sodium-Glucose Co-Transporter-2 Inhibitors as Adjuvant Therapy With Letrozole in Induction of Ovulation in Women With Polycystic Ovarian Syndrome
Source: ClinicalTrials.gov · Last updated 2 Jun 2026
Brief summary (registry, in English)
The aim of the study is to assess the efficacy of adjuvant therapy dapagliflozin, metformin as monotherapy and combination of both in comparison to control group in induction of ovulation with letrozole in women PCOS, focusing specifically on rates of ovulation and pregnancy.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 200 (actual)
- First submitted
- 4 May 2024
- Start date
- 30 Mar 2026
- Primary completion date
- 30 Mar 2026
- Lead sponsor
- Beni-Suef University
- NCT number
- NCT06405178
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 200
- From 30 Mar 2026 to the primary completion date, 30 Mar 2026
- 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.
Other illness
- Other causes of hyperandrogenism mimic PCOS such as congenital adrenal hyperplasia, Cushing's syndrome, or androgen secreting tumors are excluded.
Lab values
- Liver disease is defined as AST or ALT \> 2 times normal or total bilirubin \>2.5 mg/dL, #kidney disease defined as BUN \> 30 mg/dL or serum creatinine\> 1.4 mg/dL or significant
Other
- Persistent hyperprolactinemia,
- thyroid dysfunction defined as TSH \< 0.2 mIU/ML or \>5.5 mIU/mL)
- patients with menopausal levels of FSH (\> 15 mIU/mL) (A normal level within the last year is adequate for enter the study).
Who the study is looking for
- PCOS will based on European Society of Human Reproduction and Embryology/American Society for Reproductive Medicine (ESHRE/ASRM) criteria, the diagnosis is made when at least two of the following criteria are met:
- oilgo and/or anovulation (infrequent or no ovulation),
- clinical and/or biochemical signs of hyperandrogenism including hirsutism, acne and/or increased testosterone levels
- polycystic ovaries on ultrasound (defined as those containing at least 12 follicles measuring 2-9 mm in diameter arranged peripherally around an echo-dense stroma and/or with increased ovarian volume of at least 10 ml).
Age in the registry: 20 years to 40 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 |
|---|---|---|---|
| Beni-Suef University Hospital Coordinator of this site? Confirm its status | Banī Suwayf | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.