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.

A Multicentre, Open, Uncontrolled Study to Assess Quality of Life During Six Cycles (24 Weeks) of Treatment With an Oral Contraceptive Containing 30 µg of Ethinylestradiol and 3 mg of Drospirenone (Yasmin).

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00367276

Enrollment

221

Registered

2006-08-22

Start date

2002-12-31

Completion date

2004-05-31

Last updated

2013-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Females requiring contraceptives

Brief summary

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

Detailed description

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.

Interventions

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

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change of Psychological General Well Being Questionnaire score	pretreatment cycle to cycle 6

Secondary

Measure	Time frame
Subject evaluation of changes in greasy skin and greasy hair	baseline to cycle 6
Subject satisfaction with treatment at final visit	at final visit
Changes in body composition (evaluated by Multifrequency Bioelectrical Impedance Analysis)	pretreatment to cycle 6

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026