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. - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00367276

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 ethinylestradiol and 3 mg drospirenone (DRSP)	Phase III

Drug Information available for: Ethinyl estradiol 1,2-Dihydrospirorenone

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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).

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 ]

Arms	Assigned Interventions
Arm 1: Experimental N/A	Drug: Yasmin, 30 µg ethinylestradiol and 3 mg drospirenone (DRSP) 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

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00367276

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Responsible Party:	( Bayer Schering Pharma AG, Therapeutic Area Head )
Study ID Numbers:	91070, 305545
Study First Received:	August 11, 2006
Last Updated:	April 29, 2008
ClinicalTrials.gov Identifier:	NCT00367276
Health Authority:	Italy: Ethics Committee; United States: Food and Drug Administration

Keywords provided by Bayer:

Females requiring contraceptives

Study placed in the following topic categories:

Estradiol 3-benzoate
Estradiol valerate
Drospirenone
Ethinyl Estradiol
Quality of Life

Estradiol 17 beta-cypionate
Healthy
Polyestradiol phosphate
Estradiol

Additional relevant MeSH terms:

Estrogens
Aldosterone Antagonists
Hormone Antagonists
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009