Health Condition 1: null- POLYCYSTIC OVARY SYNDROME
Conditions
Interventions
Intervention1: Drospirenone (3mg) with 20 mcg ethinyl oestradiol: 1 tab, daily from day 1 of the first cycle for 24 days then 4 days gap and again starting 1 tab daily for 24 days and so on cyclically
Sponsors
SCDAS MEMORIAL MEDICAL AND RESEARCH CENTER
Eligibility
Inclusion criteria
Inclusion criteria: women with oligomenorrhoea diagnosed as having Polycystic ovary syndrome as per the Rotterdam criteria 2003; age- minimum gynaecological age of 3 years(age since menarche) to 35 years
Exclusion criteria
Exclusion criteria: secondary causes of hyperandrogenism like gross hypothyroidism, hyperprolactinaemia, Cushing syndrome, late onset congenital adrenal hyperplasia, contraindications of oral pill therapy,severe liver/ renal/cardiac disease; those already taken oral pills in the preceding 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| primary outcome- changes in clinical markers- BMI,Abdominal circumference, hirsutism score, acne, acanthosis nigricans and biochemical markers like serum testosterone level, SHBG level and free androgen index; PP sugar and PP insulin levels( 2 hours after taking 75 gm glucose) At 6 months and finally after 12 months of treatment. Timepoint: 6 months and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| any side effectsTimepoint: 6 months after completion of treatment and finally after 12 months of treatment | — |
Countries
India
Contacts
Public ContactDRSUDHINDRA MOHAN BHATTACHARYA
S.C.DAS MEMORIAL MEDICAL AND RESEARCH CENTER
Outcome results
None listed