Health Condition 1: E282- Polycystic ovarian syndrome
Conditions
Interventions
Intervention1: Saroglitazar: Dosage:-4 Mg
Route:- Oral
Frequency :-Once daily
Duration :-24 weeks
Intervention2: Saroglitazar: Dosage:-2 Mg
Route:- Oral
Frequency :-Once daily
Duration :-24 wee
Sponsors
Cadila Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1)PCOS according to the Rotterdam criteria and falling under Phenotype A or Phenotype B. 2)Overweight or obese patients with a BMI more than 23 kg/m2. 3)Ability to understand and give informed consent for participation.
Exclusion criteria
Exclusion criteria: 1)History of anaphylaxis or known intolerance to PPAR agonist. 2)Intake of Vitamin E ( >100 IU/day) or multivitamins containing Vitamin E ( >100 IU/day) 3 months before enrollment. 3)History of substance abuse within the past 12 months. 4)Presence of other chronic liver diseases (hepatitis B or C, autoimmune hepatitis, cholestatic liver disease, Wilsons disease, hemochromatosis, etc.). 5)In women with child bearing potential: inability or unwillingness to practice contraception for the duration of the study. 6)Pregnant or breast feeding females. 7)Women with known Cushing syndrome or hyperprolactinemia. 8)Known late onset congenital adrenal hyperplasia, androgen-producing tumors. 9)Refusal or inability to comply with the requirements of the protocol, for any reason, including scheduled clinic visits and laboratory tests. 10)History of myopathies or evidence of active muscle diseases. 11)History of significant cardiovascular disease (unstable angina, unstable cardiac dysrhythmias, uncontrolled hypertension and stroke or transient ischemic attack). 12)History of malignancy in the past 5 years. 13)History of bladder disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline to week 24 in total testosterone levels.Timepoint: Baseline and Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to week 12 and week 24 in FAI.Timepoint: Baseline, Week 12 and Week 24;Changes from baseline to week 12 and week 24 in number and size of all follicles in each ovary by ultrasonography.Timepoint: Baseline, Week 12 and Week 24;Changes from baseline to week 12 and week 24 in sex hormone binding globulinTimepoint: Baseline, Week 12 and Week 24;Changes from baseline to week 12 in total testosterone.Timepoint: Baseline and Week 12 | — |
Countries
India
Contacts
Public ContactDr Manjunath K
Cadila Healthcare Limited
Outcome results
None listed