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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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00367276
Recruitment Status : Completed
First Posted : August 22, 2006
Last Update Posted : October 11, 2013
Information provided by (Responsible Party):

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

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 221 participants
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).
Study Start Date : December 2002
Actual Study Completion Date : May 2004

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

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

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00367276

Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer

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Responsible Party: Bayer Identifier: NCT00367276    
Other Study ID Numbers: 91070
First Posted: August 22, 2006    Key Record Dates
Last Update Posted: October 11, 2013
Last Verified: October 2013
Keywords provided by Bayer:
Females requiring contraceptives
Additional relevant MeSH terms:
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Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents