Study to Evaluate the Effect of Six Cycles of Treatment With a Combined Oral Contraceptive (EE 0.30 mg/DRSP 3 mg) on Quality of Life.

Bayer221 enrolled

Overview

The purpose of this study is to evaluate the effects on the quality of life and BMI of new contraceptives.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

221

Conditions

Healthy

Interventions

Yasmin (30 µg EE, 3 mg Drospirenone, BAY86-5131)DRUG

Yasmin, SH T 470 FA; 30 µg ethinylestradiol and 3 mg drospirenone, oral administration over 6 treatment cycles, one tablet per day for 21 days followed by a 7 day pill-free interval.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female requiring contraceptives. * Aged 18 to 35 if a non-smoker, aged 18 to 30 if a smoker. * Regular menstrual cycle (defined as duration of 28 +/- 5 days). Exclusion Criteria: * No Contraindication for OC use

Outcomes

Primary Outcomes

Change of Psychological General Well Being Questionnaire score

Time frame: pretreatment cycle to cycle 6

Secondary Outcomes

Changes in body composition (evaluated by Multifrequency Bioelectrical Impedance Analysis)

Time frame: pretreatment to cycle 6

Subject satisfaction with treatment at final visit

Time frame: at final visit

Subject evaluation of changes in greasy skin and greasy hair

Time frame: baseline to cycle 6

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.