check_circleStudy Completed

Healthy

Bayer Identifier:

91070

ClinicalTrials.gov Identifier:

NCT00367276

EudraCT Number:

Not Available

EU CT Number:

Not Available
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.

Trial purpose

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

Key Participants Requirements

Sex

Female

Age

18 - 35 Years
  • - 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).
  • - No Contraindication for OC use

Trial summary

Enrollment Goal
221
Trial Dates
December 2002 - May 2004
Phase
Phase 3
Could I Receive a placebo
No
Products
Yasmin (EE30/DRSP, BAY86-5131)
Accepts Healthy Volunteer
No

Primary Outcome

  • Change of Psychological General Well Being Questionnaire score
    date_rangeTime Frame:
    pretreatment cycle to cycle 6
    enhanced_encryption
    Safety Issue:
    None

Secondary Outcome

  • Changes in body composition (evaluated by Multifrequency Bioelectrical Impedance Analysis)
    date_rangeTime Frame:
    pretreatment to cycle 6
    enhanced_encryption
    Safety Issue:
    None
  • Subject satisfaction with treatment at final visit
    date_rangeTime Frame:
    at final visit
    enhanced_encryption
    Safety Issue:
    None
  • Subject evaluation of changes in greasy skin and greasy hair
    date_rangeTime Frame:
    baseline to cycle 6
    enhanced_encryption
    Safety Issue:
    None

Trial design

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).
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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