- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07387679
Myo-inositol Versus Metformin in Patients With Polycystic Ovarian Syndrome to Treat Obesity
January 28, 2026 updated by: Muhammad Aamir Latif
Comparison of Myo-inositol Versus Metformin for Treating Obesity in Patients With Polycystic Ovarian Syndrome
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A review of the literature reveals inconsistent outcomes of myo-inositol vs metformin in the treatment of obesity and metabolic disorders in patients with PCOS, with comparable results and myo-inositol frequently demonstrating superior tolerability and reduced gastrointestinal side effects relative to metformin.
When treating obesity in women with PCOS, practicing gynecologists would be able to select more appropriate medications by gathering data from local contexts.
It will lessen psychological consequences associated with obesity, such as discrimination, stigma, low self-esteem, and poor quality of life.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Punjab Province
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Bahawalpur, Punjab Province, Pakistan, 63100
- Bahwal Victoria Hospital
-
-
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
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Females aged 18-45 years
- Diagnosed case of PCOS for more than 6 months of duration
Exclusion Criteria:
- Women with hyperprolactinemia or hypothyroidism (on history & medical record review)
- Adrenal hyperplasia or Cushing's syndrome (on history & medical record review)
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group-A
Women were given tablet myo-inositol 1 gm twice a day for 3 months.
|
Women were given tablet myo-inositol 1 gm twice a day for 3 months.
|
|
Experimental: Group-B
Women received metformin 250 mg three times daily for 3 months.
|
Women received metformin 250 mg three times daily for 3 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reduction in body mass index
Time Frame: 3 months
|
A reduction in the body mass index with respect to baseline was taken as efficacy of the treatment.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ayesha Gul, Bahawal Victoria Hospital/Quid-e-Azam Medical College, Bahawalpur
- Study Director: Shehnaz Anwar, FCPS, Bahawal Victoria Hospital/Quid-e-Azam Medical College, Bahawalpur
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 (Actual)
November 29, 2024
Primary Completion (Actual)
May 28, 2025
Study Completion (Actual)
May 28, 2025
Study Registration Dates
First Submitted
January 26, 2026
First Submitted That Met QC Criteria
January 28, 2026
First Posted (Actual)
February 4, 2026
Study Record Updates
Last Update Posted (Actual)
February 4, 2026
Last Update Submitted That Met QC Criteria
January 28, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Endocrine System Diseases
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Genital Diseases, Female
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Ovarian Cysts
- Cysts
- Polycystic Ovary Syndrome
- Organic Chemicals
- Carbohydrates
- Alcohols
- Biguanides
- Guanidines
- Amidines
- Sugar Alcohols
- Metformin
- Inositol
Other Study ID Numbers
- Dr-Ayesha-BVH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data can be shared on a reasonable request.
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.
Clinical Trials on Polycystic Ovarian Syndrome
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Northwell HealthWithdrawnPolycystic Ovarian Syndrome (PCOS) | Patients Sensitive to Exogenous Gonadotropins | Ovarian Hyper Stimulation Syndrome (OHSS)United States
-
Etlik Zubeyde Hanim Womens' Health and Teaching...CompletedOvarian Hyperstimulation Syndrome | Polycystic Ovarian Syndrome
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Wellizen AustraliaActive, not recruitingPolycystic Ovarian Syndrome (PCOS)China
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AnnieGuard Corp.Not yet recruitingPolycystic Ovary Syndrome | PCOS | Polycystic Ovary Syndrome (PCOS) | PCOS (Polycystic Ovary Syndrome)
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BioromaUnknownOvarian Hyperstimulation Syndrome | Polycystic Ovarian Syndrome | Invitro FertilizationItaly
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Mayo ClinicCompletedOverweight | Insulin Resistance | Obese | Polycystic Ovarian Syndrome (PCOS)United States
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University of Health Sciences LahoreNot yet recruitingPregnancy Outcomes | Polycystic Ovarian Syndrome (PCOS)
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Mansoura University HospitalCompleted
-
Beni-Suef UniversityCairo UniversityUnknown
-
Yale UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedPolycystic Ovarian SyndromeUnited States
Clinical Trials on Myo-inositol
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Postgraduate Institute of Dental Sciences RohtakUnknownPolycystic Ovary Syndrome | Periodontitis | Insulin Resistance
-
G. d'Annunzio UniversityUniversity of ChietiUnknown
-
Tufts Medical CenterRecruiting
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Mst.Sumyara KhatunBangladesh Medical UniversityCompletedPCOS (Polycystic Ovary Syndrome)Bangladesh
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Università degli Studi 'G. d'Annunzio' Chieti e...Unknown
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Lo.Li.Pharma s.r.lCompletedPolycystic Ovarian Syndrome (PCOS)Italy
-
AGUNCO Obstetrics and Gynecology CentreCompleted
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Lo.Li.Pharma s.r.lCompletedPCOS | Myo-inositol-resistanceBulgaria
-
National University Hospital, SingaporeNational University of SingaporeRecruitingPerinatal and Neonatal Outcomes in Pregnancies With Type 2 Diabetes Mellitus (T2DM)Singapore
-
Catholic University of the Sacred HeartCompletedPolycystic Ovary Syndrome | Menstrual Irregularity | HirsutismItaly