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A clinical trial to study the effects of two Drospirenone containing oral pills with 20 mcg and 30 mcg of ethinyl oestradiol in Polycystic ovary syndrome.

Comparative study of the effects of two oral contraceptive pills containing Drospirenone (3mg) with 30 mcg of ethinyl oestradiol and 20 mcg of ethinyl oestradiol, in polycystic ovary syndrome.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/04/002571
Enrollment
80
Registered
2012-04-13
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- POLYCYSTIC OVARY SYNDROME

Interventions

Intervention1: Drospirenone (3mg) with 30 mcg ethinyl oestradiol: 1 tab . daily from day 1 of the first cycle for 21 days then 7 days gap and again starting 1 tab daily for 21 days and so on cyclicall

Sponsors

DRSUDHINDRA MOHAN BHATTACHARYA
Lead Sponsor

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

MeasureTime 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)Timepoint: At 6 months and finally after 12 months of treatment.

Secondary

MeasureTime 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; KPC MEDICAL COLLEGE. KOLKATA

drsudhindra54@gmail.com033-24303400

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 3, 2026