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NCT Number: NCT07701525

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

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.

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Key information

Conditions

Polycystic Ovary Syndrome (PCOS) 46, XX Disorders of Sex Development Adnexal Diseases Adrenogenital Syndrome Amenorrhea Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cysts D-chiro-inositol Disorders of Sex Development Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Hemorrhage Hyperandrogenism Male Urogenital Diseases Menorrhagia Menstruation Disturbances Myo-inositol Neoplasms Oligomenorrhea Ovarian Cysts Ovarian Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Polycystic Ovary Syndrome Urogenital Abnormalities Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Nishtar Medical University and Hospital Multan

Multan, Punjab Province, 60000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosed case of PCOS, ≥ 6-months

Exclusion criteria

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

Treatment and study plan

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.

placebo (folic acid)

Drug

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

Primary outcomes

  1. Improvement in Menstrual Irregularity

    Time frame: From enrollment to the end of treatment at 3 months

    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.

Other outcomes

  1. Serum LH, FSH, and Testosterone levels

    Time frame: At baseline at enrollment to the end of treatment at 3 months

    Serum FSH, LH, and testosterone concentration measured using venous blood samples collected before treatment and after 3 months of therapy.

Sponsors and collaborators

Lead sponsor

Nishtar Medical University

Other

Registry information

Official study title

Effect of Myo-Inositol and D-Chiro-Inositol Combination Therapy on Improvement in Menstrual Irregularities and Biochemical Characteristics in Patients With Polycystic Ovarian Syndrome

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 14, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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