A clinical trial to study the effects of an oral pill containing drospirenone on various clinical and biochemical parameters of polycystic ovary syndrome.

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000974

Enrollment

Registered

2009-12-11

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: ORAL ADMINISTRATION OF ETHINYL OESTRADIOL WITH DROSPIRENONE: 1 TABLET DAILY FOR 21 DAYS THEN 7 DAYS GAP AND TO RESTART AGAIN CYCLICALLY- FOR 6 MONTHS AND THEN EVALUATION AND FURTHER 6 M

Eligibility

Inclusion criteria

Inclusion criteria: WOMEN WITH POLYCYSTIC OVARY SYNDROME DIAGNOSED AS PER THE ROTTERDAM 2003 CRITERIA, AGE GROUP 14-40 YEARS,

Exclusion criteria

Exclusion criteria: SECONDARY CAUSES OF HYPERANDROGENISM; HISTORY OF ANY HORMONE INTAKE IN THE PRECEDING 3 MONTHS; MEDICAL CONDITIONS CONTRAINDICATED FOR COMBINED HORMONE THERAPY.

Design outcomes

Primary

Measure	Time frame
CHANGES IN CLINICAL PARAMETERS LIKE BMI, ABDOMINAL CIRCUMFERENCE; HIRSUTISM; ACNE; ACANTHOSIS NIGRICANS; CHANGES IN SERUM TESTOSTERONE LEVEL, SHBG LEVEL, FREE ANDROGEN INDEX;INSULIN RESISTANCE AS MEASURED BY FASTING GLUCOSE: INSULIN RATIO; CHANGES IN PPSUGAR AND PP INSULIN (AFTER TAKING 75 GM OF GLUCOSE IN EMPTY STOMACH).Timepoint: fIST TIME OF ASSESSMENT - AFTER 6MONTHS OF TREATMENT SECOND TIME OF ASSESSMENT- AFTER 12 MONTHS OF TREATMENT	—

Measure

Time frame

CHANGES IN CLINICAL PARAMETERS LIKE BMI, ABDOMINAL CIRCUMFERENCE; HIRSUTISM; ACNE; ACANTHOSIS NIGRICANS; CHANGES IN SERUM TESTOSTERONE LEVEL, SHBG LEVEL, FREE ANDROGEN INDEX;INSULIN RESISTANCE AS MEASURED BY FASTING GLUCOSE: INSULIN RATIO; CHANGES IN PPSUGAR AND PP INSULIN (AFTER TAKING 75 GM OF GLUCOSE IN EMPTY STOMACH).Timepoint: fIST TIME OF ASSESSMENT - AFTER 6MONTHS OF TREATMENT SECOND TIME OF ASSESSMENT- AFTER 12 MONTHS OF TREATMENT

—

Secondary

Measure	Time frame
SIDE EFFECTS AND COMPLIANCE WITH THE STUDY MEDICATIONTimepoint: FIRST AFTER 6 MONTHS AND FINALLY AFTER 12 MONTHS OF TREATMENT.	—

Countries

India

Contacts

Public ContactDR SUDHINDRA MOHAN BHATTACHARYA

CONSULTANT OBSTETRICIAN & GYNAECOLOGIST; S.C.DAS MEMORIAL MEDICAL & RESEARCH CENTER. KOLKATA

drsudhindra54@gmail.com033-24836330

Outcome results

None listed

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