Clinical trial · Interventional
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
NCT06405178CI-TRIAL-00113231completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary | — | UNRESOLVED | — |
Interventions
Interventions (4)
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Metformin 1000mg
- interventionNames
- Drug: Metformin
- Drug: Letrozole
- type
- EXPERIMENTAL
- label
- Dapagliflozin 10mg
- interventionNames
- Drug: Dapagliflozin
- Drug: Letrozole
- type
- EXPERIMENTAL
- label
- Dapagliflozin-Metformin 10/1000mg
- interventionNames
- Drug: Dapagliflozin/Metformin
- Drug: Letrozole
- type
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * 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). Exclusion Criteria: * Other causes of hyperandrogenism mimic PCOS such as congenital adrenal hyperplasia, Cushing's syndrome, or androgen secreting tumors are excluded. * 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). * 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
References
Publications (0)
Data not yet available
No reference posted for this study.