NCT07387679

Brief Summary

There are considerable gaps in the comparative effectiveness and tolerability of myo-inositol and metformin for treating obesity in patients with polycystic ovarian syndrome (PCOS). The current study aimed to give insights comparing myo-inositol versus metformin for treating obesity in patients with PCOS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 29, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
Last Updated

February 4, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

January 26, 2026

Last Update Submit

January 28, 2026

Conditions

Polycystic Ovarian Syndrome

Outcome Measures

Primary Outcomes (1)

  • Reduction in body mass index

    A reduction in the body mass index with respect to baseline was taken as efficacy of the treatment.

    3 months

Study Arms (2)

Group-A

EXPERIMENTAL

Women were given tablet myo-inositol 1 gm twice a day for 3 months.

Drug: Myo-inositol

Group-B

EXPERIMENTAL

Women received metformin 250 mg three times daily for 3 months.

Drug: Metformin

Interventions

Myo-inositolDRUG

Women were given tablet myo-inositol 1 gm twice a day for 3 months.

Group-A
MetforminDRUG

Women received metformin 250 mg three times daily for 3 months.

Group-B

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Females aged 18-45 years
  • Diagnosed case of PCOS for more than 6 months of duration

You may not qualify if:

  • Women with hyperprolactinemia or hypothyroidism (on history \& medical record review)
  • Adrenal hyperplasia or Cushing's syndrome (on history \& medical record review)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahwal Victoria Hospital

Bahawalpur, Punjab Province, 63100, Pakistan

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

InositolMetformin

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydratesBiguanidesGuanidinesAmidines

Study Officials

  • Ayesha Gul

    Bahawal Victoria Hospital/Quid-e-Azam Medical College, Bahawalpur

    PRINCIPAL INVESTIGATOR

  • Shehnaz Anwar, FCPS

    Bahawal Victoria Hospital/Quid-e-Azam Medical College, Bahawalpur

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Consultant

Study Record Dates

First Submitted

January 26, 2026

First Posted

February 4, 2026

Study Start

November 29, 2024

Primary Completion

May 28, 2025

Study Completion

May 28, 2025

Last Updated

February 4, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Data can be shared on a reasonable request.

Locations

PA(1)