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A clinical trial to study the effects of three drugs, desogestrel with ethinyl oestradiol, cyproterone acetate with ethinyl oestradiol and drospirenone with ethinyl oestradiol in patients with polycystic ovary syndrome.

Therapeutic effects of three different combined preparations of ethinyl oestradiol (with desogestrel, cyproterone acetate, drospirenone) in patients with PCOS: a randomized single-blind trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2010/091/000332
Enrollment
150
Registered
2010-04-12
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

None listed

Interventions

Intervention1: Ethinyl oestradiol with desogestrel: 1 tablet daily from day 1 of period for 21 days then 7 days gap and again for 21 days and so on cyclically for 6 months. Control Intervention1: Ethi

Sponsors

DR.SUDHINDRA 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 - from 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 disease, renal disease, cardiac disease; those who had already taken oral pills in the preceding 3 months

Design outcomes

Primary

MeasureTime frame
primary outcome- changes in clinical markers like BMI, Abdominal circumference, hirsutism score, acne, acanthosis nigricans.and biochemical markers like serum testosterone levels, SHBG levels and free androgen index; fasting sugar and fasting insulin levels and glucose: insulin ratio.Timepoint: baseline at the beginning of treatment. finally after 6 months of treatment.

Secondary

MeasureTime frame
secondary out come- any side effects notedTimepoint: 6 months after treatment completion.

Countries

India

Contacts

Public ContactDR.SUDHINDRA MOHAN BHATTACHARYA
drsudhindra54@gmail.com033-24303400

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 26, 2026