Metformin Versus Myo-inositol in the Management of Polycystic Ovarian Disease: A Comparative Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Myoinositol, Metformin.
- Who it may be relevant to
- Registry conditions: Polycystic Ovarian Syndrome (PCOS). Basic parameters: 16 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug Myoinositol
In group A, females will be prescribed oral myoinositol 1g twice daily for 3 months. - Drug Metformin
In group B, females will be prescribed oral sustained-release metformin 850 mg twice daily for 3 months.
Primary outcome measures
- LH/FSH ratio [Time frame: 3 Months]
- Regular cycles [Time frame: 3 Months]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- CMH Gujranwala — Guiranwala
Identifiers
NCT: NCT07459595 · 23