A clinical trial to study the effects of two drugs, Drospirenone & Ethinyl estradiol, on Quality of life when used as an oral contraceptive.
- Conditions
- Health Condition 1: null- Quality of Life in patients who are taking oral contraceptive.
- Registration Number
- CTRI/2010/091/001229
- Lead Sponsor
- Glenmark Pharmaceutical Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 500
Married females with age >18 to 40 yrs
Healthy women with history of normal menses or cycles [mean cycle duration of 28+/-5 days]
Women willing to give written Informed Consent & willing to come for follow up
Hypersensitivity / contraindication to Drospirenone or any ingredients of the oral contraceptive pill
Pregnant and lactating women or with unexplained vaginal bleeding.
BMI >25 or with history of metabolic or endocrine disorders
History of psychoactive disease or on antidepressants
Aspartate aminotransferase (AST) and/or alanine -aminotransferase (ALT) 2.5 x ULN or lower
Serum creatinine 1.5 x ULN
Any condition likely to hamper compliance of the patient with the study protocol
Participated in a new drug study in past 3 months
Women with hypertension, hypercholesterolemia, diabetes
Women with history of smoking, myocardial infarction, stroke, peripheral vascular disease, or clotting disorders
Women on oral anticoagulants or prolonged use of high doses of NSAIDs
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical assessment <br>?Safety and Tolerability<br>This would be noted down by monitoring body weight, acne counts for fresh lesions & analyzed at the end of 3rd cycle<br><br>?Global Assessment of Quality of Life Scale using Q-LES-Q*<br>Patient?s perception about quality of life would be noted down & analyzed at the end of 3rd cycle<br><br>? Contraceptive Efficacy<br>This would be determined by noting down unintended pregnancy that occurred during the study period<br>Timepoint: 3 cycles
- Secondary Outcome Measures
Name Time Method ILTimepoint: NI