Adjuvant Therapy With Letrozole in Induction of Ovulation With Polycystic Ovarian Syndrome
- Sponsor
- Beni-Suef University
- Study ID
- NCT06405178
- Phase
- PHASE3
- Status
- Completed
Conditions
- Polycystic Ovary
Eligibility Criteria
- Sex
- FEMALE
- Age
- 20 Years - 40 Years
- Healthy Volunteers
- Not accepted
Interventions
- Metformin — DRUGInsulin Sensitizer
- Dapagliflozin — DRUGSodium-Glucose Co-transporter-2
- Dapagliflozin/Metformin — DRUGAnti diabetic drug
- Letrozole — DRUGAromataze inhibitor
Study Details
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.
Key Dates
- Start date
- Mar 30, 2026
- Status verified
- May 2026
- Primary completion
- Mar 30, 2026
- Completion
- Apr 1, 2026
Study Design
- Enrollment
- 200 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Metformin 1000mg
- Experimental: Dapagliflozin 10mg
- Experimental: Dapagliflozin-Metformin 10/1000mg
- No Intervention: control group.
Primary Outcome Measure
Pregnancy [ Time Frame: 3 cycles ( 3 months / one month for each cycle) ]
Related coverage on Hipa.ai
- Dapagliflozin Phase 3 Trial for Polycystic Ovary Syndrome CompletesDapagliflozin · Mar 30, 2026 · ClinicalTrials.gov