NCT00367276

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
221

participants targeted

Target at P50-P75 for phase_3 healthy

Timeline
Completed

Started Dec 2002

Typical duration for phase_3 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2006

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 22, 2006

Completed
Last Updated

October 11, 2013

Status Verified

October 1, 2013

First QC Date

August 11, 2006

Last Update Submit

October 10, 2013

Conditions

Healthy

Keywords

Females requiring contraceptives

Outcome Measures

Primary Outcomes (1)

  • Change of Psychological General Well Being Questionnaire score

    pretreatment cycle to cycle 6

Secondary Outcomes (3)

  • Changes in body composition (evaluated by Multifrequency Bioelectrical Impedance Analysis)

    pretreatment to cycle 6

  • Subject satisfaction with treatment at final visit

    at final visit

  • Subject evaluation of changes in greasy skin and greasy hair

    baseline to cycle 6

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: Yasmin (30 µg EE, 3 mg Drospirenone, BAY86-5131)

Interventions

Yasmin (30 µg EE, 3 mg Drospirenone, BAY86-5131)DRUG

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.

Arm 1

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • No Contraindication for OC use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

drospirenone and ethinyl estradiol combinationdrospirenone

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2006

First Posted

August 22, 2006

Study Start

December 1, 2002

Study Completion

May 1, 2004

Last Updated

October 11, 2013

Record last verified: 2013-10