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NCT Number: NCT07459595

Metformin Versus Myo-inositol in the Management of Polycystic Ovarian Disease: A Comparative Study

In polycystic ovary syndrome (PCOS), changes in physical appearance i.e. weight gain, hirsutism, menstrual disturbances and infertility result in reduced quality-of-life. PCOS is one of the most common endocrine disorders affecting about 4% to 8% of women of reproductive age. Diagnosis is primarily clinical with Rotterdam criteria being the most commonly followed criteria, which require the presence of two out of the three criteria including oligo and/or anovulation, clinical and/or biochemical signs of hyperandrogenism and polycystic ovaries on ultrasound.

The objective of this study is to compare the outcome of Metformin versus Myo-inositol in the management of polycystic ovarian disease.

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Key information

Conditions

Polycystic Ovarian Syndrome (PCOS) Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

16 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Married or unmarried
  • Diagnosed with PCOS (females presenting with compliant of irregular cycle for >3 months, with hirsutism, acne, presence of polycystic ovaries detected on ultrasound ).

Exclusion criteria

  • Females already taken or taking PCOS treatment (on medical record)
  • Females already enrolled in another trial program
  • Females already taking trial drugs
  • Females with chronic diabetes (BSR>200 mg/dl), hypertension (BP≥140/90mmHg)
  • Females with PCOS along with gestational sac (on ultrasound)
  • Females allergic to any content of trial drugs (on history)

Treatment and study plan

Myoinositol

Drug

In group A, females will be prescribed oral myoinositol 1g twice daily for 3 months.

metformin

Drug

In group B, females will be prescribed oral sustained-release metformin 850 mg twice daily for 3 months.

Primary outcomes

  1. LH/FSH ratio

    Time frame: 3 Months

    It will be assessed in terms of ratio between LH and FSH after 3 months of treatment.

  2. Regular cycles

    Time frame: 3 Months

    It will be labeled if number of days from the start (day 1) of one period until the start (day 1) of the next period are almost equal for at least 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Fatima Tariq, MBBS

CONTACT

[email protected]

+92315491846

Sponsors and collaborators

Lead sponsor

Fatima Tariq

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 10, 2026
Registry last updated
Mar 10, 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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