Polycystic Ovarian Syndrome (PCOS)
Conditions
Keywords
Metformin, Myo-inositol, Polycystic Ovarian Syndrome (PCOS)
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.
Interventions
DRUGMyoinositol
In group A, females will be prescribed oral myoinositol 1g twice daily for 3 months.
DRUGMetformin
In group B, females will be prescribed oral sustained-release metformin 850 mg twice daily for 3 months.
Sponsors
Fatima Tariq
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 45 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LH/FSH ratio | 3 Months | It will be assessed in terms of ratio between LH and FSH after 3 months of treatment. |
| Regular cycles | 3 Months | 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 |
Countries
Pakistan
Contacts
CONTACTDr Fatima Tariq, MBBS
Outcome results
None listed