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

NCT07459595 | Not Yet Recruiting Phase 1

• 1 other identifier: 23
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Polycystic Ovarian Syndrome (PCOS)

Keywords

Metformin; Myo-inositol; Polycystic Ovarian Syndrome (PCOS)

Outcome Measures

Primary Outcomes (2)

• LH/FSH ratio

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

  3 Months

• Regular cycles

  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

Study Arms (2)

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

EXPERIMENTAL

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 B, females will be prescribed oral metformin 850 mg twice daily for 3 months

ACTIVE COMPARATOR

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

Interventions

Myoinositol DRUG

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

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.

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

Eligibility Criteria

• Age: 16 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 ).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fatima Tariq: lead

Study Sites (1)

CMH Gujranwala

Gujranwala, Punjab Province, 52230, Pakistan

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Inositol; Metformin

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

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Biguanides; Guanidines; Amidines

Central Study Contacts

Dr Fatima Tariq, MBBS

CONTACT

+92315491846; ftmtariq@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 10, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)