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A clinical trial to study the effects of an oral pill containing desogestrel in women with polycystic ovary syndrome.

Effects of combination of ethinyl oestradiol with desogestrel on clinical and biochemical parameters in women with polycystic ovary syndrome.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2009/091/000370
Enrollment
30
Registered
2010-02-01
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- EFFECTS ON CLINICAL PARAMETERS - BMI, ABDOMINAL CIRCUMFERENCE, HIRSUTISM, ACNE, BLOOD PRESSURE

Interventions

Intervention1: Ethinyl oestradiol with desogestrel: 1 tab. daily for 21 days then 7 days gap and to restart- 6 months- then evaluations of response and then finally at 12 months. Control Intervention1

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: women with polycystic ovary syndrome , diagnosed as per Rotterdam 2003 criteria

Exclusion criteria

Exclusion criteria: secondary causes of hyperandrogenism; those already on oestrogenic preparations in the preceding three months; hypothyroidism, hyperprolactinaemia, women with severe liver diseases, renal diseases, cardiac diseases.

Design outcomes

Primary

MeasureTime frame
changes in clinical parameters like BMI, Waist-hip ratio, abdominal circumference, hirsutism score, acne lesions, changes in serum testosterone, SHBG(sex hormone binding globulin) levels, free androgen index, insulin resistance as measured by fasting glucose: insulin ratioTimepoint: first time of assessment- 6 months second time of assessment- 12 months after start of treatment.

Secondary

MeasureTime frame
side effects and compliance with the medicationTimepoint: first after 6 months and finally after 12 months.

Countries

India

Contacts

Public ContactDRSUDHINDRA MOHAN BHATTACHARYA

Consultant, S.C.Das Memorial Medical and Research Center.

drsudhindra54@gmail.com033-24836330

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026