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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00367276
First Posted: August 22, 2006
Last Update Posted: October 11, 2013
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.
Information provided by (Responsible Party):
Bayer
  Purpose
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.
  Eligibility

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.


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

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
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 ClinicalTrials.gov identifier (NCT number): NCT00367276


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00367276     History of Changes
Other Study ID Numbers: 91070
305545
First Submitted: August 11, 2006
First Posted: August 22, 2006
Last Update Posted: October 11, 2013
Last Verified: October 2013

Keywords provided by Bayer:
Females requiring contraceptives

Additional relevant MeSH terms:
Contraceptive Agents
Contraceptives, Oral
Drospirenone
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
Diuretics
Natriuretic Agents
Estrogens
Hormones