Skip to main content
OpenTrials
Completed

NCT Number: NCT00367276

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.

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change of Psychological General Well Being Questionnaire score

    Time frame: pretreatment cycle to cycle 6

Secondary outcomes

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

    Time frame: pretreatment to cycle 6

  2. Subject satisfaction with treatment at final visit

    Time frame: at final visit

  3. Subject evaluation of changes in greasy skin and greasy hair

    Time frame: baseline to cycle 6

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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).

Important dates

Study start
2002
Study completion
2004
First posted
Aug 22, 2006
Registry last updated
Oct 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.