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COMPLETED
NCT07585396
PHASE2/PHASE3

Inositol in Letrozol Resistant PCOS Women

Sponsor: Kafrelsheikh University

View on ClinicalTrials.gov

Summary

Polycystic ovary syndrome (PCOS),is a complex neuro-endocrine disorder affecting approximately 5% to 10% of women in reproductive age.Inositols are considered insulin sensitizers, as they modulate the members of insulin signaling pathways.Thiss study compares between the effect of inositol and metformin in letrozol resistant PCOS women.

Official title: Efficacy of Inositol in Managing Subfertility in Letrozole-resistant Polycystic Ovary Syndrome Women

Key Details

Gender

FEMALE

Age Range

20 Years - 38 Years

Study Type

INTERVENTIONAL

Enrollment

136

Start Date

2024-04-10

Completion Date

2026-07-11

Last Updated

2026-09-29

Healthy Volunteers

No

Interventions

DRUG

Myoinositol

Myo-inositol 2 g orally twice daily (4 g/day) for 8 weeks as metabolic priming, followed by letrozole 7.5 mg/day orally on cycle days 3-7 for three consecutive cycles. Folic acid 400 µg/day is administered throughout the study.

DRUG

Metformin

Metformin initiated at 500 mg orally once daily and increased by 500 mg weekly as tolerated to a target dose of 1500 mg/day, administered for 8 weeks as metabolic priming, followed by letrozole 7.5 mg/day orally on cycle days 3-7 for three consecutive cycles. Folic acid 400 µg/day is administered throughout the study.

Locations (1)

Kafrelshiekh university hospital

Cairo, Egypt