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

March 5, 2026 updated by: Fatima Tariq

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab Province
      • Gujranwala, Punjab Province, Pakistan, 52230

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: In group A, females will be prescribed oral myoinositol 1g twice daily for 3 months
Informed consent will be obtained from each female. Demographic data (name, age, height and weight for BMI, duration of symptoms (irregular cycles from how many months), marital status, parity, residence, socioeconomic status, diet pattern, family history of PCOS, and life style will be recorded. Females will be asked for their menstrual cycle duration and irregularity. Females will be prescribed oral myoinositol 1g twice daily for 3 months. All females will be followed-up in OPD for 3 months. After 3 months, females will be asked for their menstrual cycle duration and regularity. Reports will be assessed and levels will be recorded. If females will have regular cycles, then it will be noted. Females will be asked to give a blood sample on 3rd day of menstrual cycle and LH/FSH ratio will be noted. All this data will be recorded in a specially designed proforma
Drug: Myoinositol
In group A, females will be prescribed oral myoinositol 1g twice daily for 3 months.
Active Comparator: In group B, females will be prescribed oral metformin 850 mg twice daily for 3 months
Informed consent will be obtained from each female. Demographic data (name, age, height and weight for BMI, duration of symptoms (irregular cycles from how many months), marital status, parity, residence, socioeconomic status, diet pattern, family history of PCOS, and life style will be recorded. Females will be asked for their menstrual cycle duration and irregularity. Females will be prescribed oral sustained-release metformin 850 mg twice daily for 3 months. All females will be followed-up in OPD for 3 months. After 3 months, females will be asked for their menstrual cycle duration and regularity. Reports will be assessed and levels will be recorded. If females will have regular cycles, then it will be noted. Females will be asked to give a blood sample on 3rd day of menstrual cycle and LH/FSH ratio will be noted. All this data will be recorded in a specially designed proforma.
Drug: Metformin
In group B, females will be prescribed oral sustained-release metformin 850 mg twice daily for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LH/FSH ratio
Time Frame: 3 Months
It will be assessed in terms of ratio between LH and FSH after 3 months of treatment.
3 Months
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
3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fatima Tariq

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

March 5, 2026

First Submitted That Met QC Criteria

March 5, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23 (SIME)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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