drugset / Trial / NCT07701525

Myo-Inositol and D-Chiro-Inositol for Menstrual Irregularities and Hormone Changes in Women With Polycystic Ovarian Syndrome

NCT07701525

Phase 4 Completed 60 enrolled Nishtar Medical University
RandomizedParallel-groupDouble-blindTreatment

Summary

The goal of this clinical trial is to determine whether a combination of myo-inositol (MI) and D-chiro-inositol (DCI) with folic acid is more effective than placebo (Folic acid alone) in improving menstrual irregularities and hormone levels in women with polycystic ovarian syndrome (PCOS). The main questions this study aims to answer are: 1. Does treatment with myo-inositol and D-chiro-inositol improve menstrual regularity in women with PCOS compared with placebo? 2. Does the treatment improve biochemical characteristics, including luteinizing hormone (LH), follicle-stimulating hormone (FSH), and testosterone levels, compared with placebo? Researchers will compare a combination of myo-inositol and D-chiro-inositol with a placebo (folic acid alone) to determine whether the combination therapy is more effective in treating PCOS-related menstrual and hormonal abnormalities. Participants will: * Be randomly assigned to receive either a myo-inositol and D-chiro-inositol combination tablet (40:1 ratio) or placebo twice daily for 3 months. * Have blood samples collected before starting treatment and after 3 months to measure LH, FSH, and testosterone levels. * Attend monthly follow-up visits during the 3-month treatment period to assess changes in menstrual regularity and monitor their progress. The study will enroll 60 women aged 18-45 years with PCOS at the Department of Obstetrics and Gynecology, Nishtar Hospital Multan. The results may help determine whether myo-inositol and D-chiro-inositol combination therapy is an effective treatment for improving menstrual function and hormonal abnormalities in women with PCOS.

Timeline

Start
2025-06-01
Primary completion
2025-11-30
Completion
2025-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject D-chiro-inositol Small molecule 13.8 mg Oral
Subject Inositol Small molecule 550 mg Oral
Comparator folic acid Other / unclassified 200 ug Oral