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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.

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: August 11, 2006
Last updated: October 10, 2013
Last verified: October 2013
The purpose of this study is to evaluate the effects on the quality of life and BMI of new contraceptives.

Condition Intervention Phase
Healthy Drug: Yasmin (30 µg EE, 3 mg Drospirenone, BAY86-5131) Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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).

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Change of Psychological General Well Being Questionnaire score [ Time Frame: pretreatment cycle to cycle 6 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 221
Study Start Date: December 2002
Study Completion Date: May 2004
Arms Assigned Interventions
Experimental: Arm 1 Drug: Yasmin (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.

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.

Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00367276

Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT00367276     History of Changes
Other Study ID Numbers: 91070
Study First Received: August 11, 2006
Last Updated: October 10, 2013

Keywords provided by Bayer:
Females requiring contraceptives

Additional relevant MeSH terms:
Contraceptive Agents
Contraceptives, Oral
Ethinyl Estradiol
Contraceptives, Oral, Combined
Drospirenone and ethinyl estradiol combination
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Diuretics, Potassium Sparing
Natriuretic Agents
Hormones processed this record on August 18, 2017