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

Phase 4

Completed

• Conditions: Health Condition 1: null- POLYCYSTIC OVARY SYNDROME; CLINICAL AND BIOCHEMICAL CHANGES

• Registration Number: CTRI/2009/091/000974
• Lead Sponsor: DRSUDHINDRA MOHAN BHATTACHARYA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 <br/ ><br>SECOND TIME OF ASSESSMENT- AFTER 12 MONTHS OF TREATMENT

Secondary Outcome Measures

Name	Time	Method
SIDE EFFECTS AND COMPLIANCE WITH THE STUDY MEDICATIONTimepoint: FIRST AFTER 6 MONTHS AND FINALLY AFTER 12 MONTHS OF TREATMENT.