A clinical trial to study the effects of two drugs, Drospirenone & Ethinyl estradiol, on Quality of life when used as an oral contraceptive.

Safety Assessment of Oral Contraceptive pill containing Drospirenone & Ethinyl estradiol on Quality of life.

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2010/091/001229

Enrollment

500

Registered

2010-10-08

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- Quality of Life in patients who are taking oral contraceptive.

Interventions

Intervention1: Asmita (Fixed dose combination of Drospirenone & Ethinyl estradiol: 21 active tablets each containing 3.0 mg of drospirenone and 30 mcg of ethinyl estradiol administered for 21 days fol

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Clinical assessment ? Safety and Tolerability This would be noted down by monitoring body weight, acne counts for fresh lesions & analyzed at the end of 3rd cycle ? Global Assessment of Quality of Life Scale using Q-LES-Q* Patient?s perception about quality of life would be noted down & analyzed at the end of 3rd cycle ? Contraceptive Efficacy This would be determined by noting down unintended pregnancy that occurred during the study period Timepoint: 3 cycles	—

Measure

Time frame

Clinical assessment ? Safety and Tolerability This would be noted down by monitoring body weight, acne counts for fresh lesions & analyzed at the end of 3rd cycle ? Global Assessment of Quality of Life Scale using Q-LES-Q* Patient?s perception about quality of life would be noted down & analyzed at the end of 3rd cycle ? Contraceptive Efficacy This would be determined by noting down unintended pregnancy that occurred during the study period Timepoint: 3 cycles

—

Secondary

Measure	Time frame
NILTimepoint: NIL	—

Countries

India

Contacts

Public ContactDr Krishnaprasad

kkrishna@glenmarkpharma.com02240889083

Outcome results

None listed

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