Inositol in Letrozol Resistant PCOS Women

NCT07585396 | Completed Phase 2 FDA Drug

• 1 other identifier: KFSIRB200-600
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Polycystic Ovary Syndrome; Infertility

Keywords

Inositol; Letrozol; PCOS

Outcome Measures

Primary Outcomes (1)

• Cumulative Ovulation rate over 3 cycles confirmed by folliculometry measured by transvaginal ultrasound

  5 months (8 weeks priming phase + 3 consecutive cycles of letrozole )

Secondary Outcomes (1)

• * clinical pregnancy

  5 months ( 8weeks of priming phase + 3 consecutive cycles of letrozole )

Study Arms (2)

Myoinositol group

ACTIVE COMPARATOR

Phase A (Priming phase) : myo-inositol 2 g twice daily for 8 weeks Phase B ( ovulation induction ): letrozole 7.5 mg/day on cycle days 3-7 for up to three cycles or until clinical pregnancy. Folic acid 400 µg/day is administered throughout the study.

Drug: Myoinositol

Metformin group

ACTIVE COMPARATOR

PhaseA( priming phase) : Metformin initiated at 500mg oral once daily and increased by 500 mg weekly as tolerated to a target dose of 1500 mg/day Phase B(induction ) : letrozole 7.5 mg/day on cycle days 3-7 for three consecutive cycles or until clinical pregnancy Folic acid 400 µg/day is administered throughout the study.

Drug: Metformin

Interventions

Myoinositol DRUG

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.

Myoinositol group

Metformin DRUG

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.

Metformin group

Eligibility Criteria

• Age: 20 Years - 38 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 20- 38 years old.
• Diagnosis of PCOS according to Rotterdam criteria
• Letrozole resistant cases.
• Normal thyroid hormone level.
• Normal prolactin hormone level.

You may not qualify if:

• History of ovarian surgery.
• cases associated with endometriosis.
• History of diabetes mellitus.
• Allergy to myo-Inositol .

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelshiekh university hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Infertility

Interventions

Inositol; Metformin

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Biguanides; Guanidines; Amidines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label trial. Participants and dispensing staff are not masked to treatment assignment because the two interventions differ in formulation and dosing. Investigators performing folliculometry and confirming ovulation, laboratory personnel processing progesterone and β-hCG assays, the adverse-event assessor, and the statistician are blinded to treatment assignment. Participants are instructed not to disclose their treatment regimen to outcome assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 13, 2026
• Study Start: April 10, 2024
• Primary Completion: June 10, 2026
• Study Completion: July 11, 2026
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)