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

NCT07701525 | Completed Phase 4

• 1 other identifier: U1111-1343-2897
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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:

• 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.

Conditions

Polycystic Ovary Syndrome (PCOS); Myo-inositol; D-chiro-inositol

Keywords

Menstrual Irregularities; Oligomenorrhea; Amenorrhea; Menorrhagia; Hyperandrogenism; Testosterone; Luteinizing Hormone; Follicle-Stimulating Hormone; PCOS

Outcome Measures

Primary Outcomes (1)

• Improvement in Menstrual Irregularity

  The proportion of participants achieving improvement in menstrual irregularity after treatment. Improvement is defined as restoration of a regular menstrual cycle with an average cycle length of 24-32 days and menstrual blood loss of 21-50 mL per cycle. Menstrual irregularity includes amenorrhea, oligomenorrhea, or menorrhagia assessed through participant menstrual history.

  From enrollment to the end of treatment at 3 months

Other Outcomes (1)

• Serum LH, FSH, and Testosterone levels

  At baseline at enrollment to the end of treatment at 3 months

Study Arms (2)

Myo-Inositol and D-Chiro-Inositol Combination Therapy

EXPERIMENTAL

Participants will receive a combination tablet containing myo-inositol, D-chiro-inositol, and folic acid

Drug: Myo-Inositol and D-Chiro-Inositol Combination Therapy

Placebo

PLACEBO COMPARATOR

Participants will receive folic acid tablets orally

Drug: placebo (folic acid)

Interventions

Myo-Inositol and D-Chiro-Inositol Combination Therapy DRUG

Participants will receive an oral combination tablet containing myo-inositol (550 mg), D-chiro-inositol (13.8 mg) in a 40:1 ratio, and folic acid (200 µg), taken twice daily for 3 months.

Myo-Inositol and D-Chiro-Inositol Combination Therapy

placebo (folic acid) DRUG

Participants will receive oral folic acid (200 µg) tablets twice daily for 3 months.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• diagnosed case of PCOS, ≥ 6-months

You may not qualify if:

• Hyperprolactinemia, hypothyroidism, adrenal hyperplasia or Cushing's syndrome (on history \& medical record review)

Sponsors & Collaborators

• Nishtar Medical University: lead

Study Sites (1)

Nishtar Medical University and Hospital Multan

Multan, Punjab Province, 60000, Pakistan

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Menstruation Disturbances; Oligomenorrhea; Amenorrhea; Menorrhagia; Hyperandrogenism

Interventions

Inositol; Folic Acid

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; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Hemorrhage; Uterine Diseases; Hemorrhage; 46, XX Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Adrenogenital Syndrome; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mehnaz K Professor, FCPS

  Nishtar Medical University and Hospital Multan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start: June 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)