About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 ).
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
Myoinositol
DrugIn group A, females will be prescribed oral myoinositol 1g twice daily for 3 months.
Metformin
DrugIn group B, females will be prescribed oral sustained-release metformin 850 mg twice daily for 3 months.
Treatment groups
Trial outcomes
Primary outcomes
LH/FSH ratio
It will be assessed in terms of ratio between LH and FSH after 3 months of treatment.
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
Sponsors and contacts
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Fatima Tariq
Lead sponsor
Combined Military Hospital Gujranwala
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options: