NCT00185484

Brief Summary

The purpose of this study is to determine whether the study drug is effective in prevention of pregnancy in healthy women in reproductive age

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,113

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2004

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

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

December 31, 2014

Status Verified

December 1, 2014

First QC Date

September 13, 2005

Last Update Submit

December 30, 2014

Conditions

Contraception

Keywords

Oral contraception

Outcome Measures

Primary Outcomes (1)

  • Rate of unintended pregnancies (Pearl index)

    13 cycles of 28 days

Secondary Outcomes (4)

  • Physical and gynecological examination

    screening, cycle 6 and final examination

  • Vital signs

    each visit

  • Body weight

    each visit

  • Cervical smear

    each visit

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)

Interventions

YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)DRUG

Oral administration of YAZ (0.02mg ethinyl estradiol-ß-cyclodextrin clathrate and 3mg drospirenone, 24 day hormone tablets followed by 4 days of placebo tablets for 13 cycles

Arm 1

Eligibility Criteria

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

You may qualify if:

  • Healthy woman requesting contraception
  • Age between 18 and 35 years (inclusive), smokers maximum age of 30 years (inclusive)

You may not qualify if:

  • Any conditions might interfere study outcome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Anttila L, Neunteufel W, Petraglia F, Marr J, Kunz M. Cycle control and bleeding pattern of a 24/4 regimen of drospirenone 3 mg/ethinylestradiol 20 mug compared with a 21/7 regimen of desogestrel 150 mug/ethinylestradiol 20 mug: a pooled analysis. Clin Drug Investig. 2011;31(8):519-525. doi: 10.2165/11590260-000000000-00000.

    PMID: 21721590RESULT

  • Anttila L, Bachmann G, Hernadi L, Kunz M, Marr J, Klipping C. Contraceptive efficacy of a combined oral contraceptive containing ethinyloestradiol 20 mug/drospirenone 3mg administered in a 24/4 regimen: a pooled analysis of four open-label studies. Eur J Obstet Gynecol Reprod Biol. 2011 Apr;155(2):180-2. doi: 10.1016/j.ejogrb.2010.12.037. Epub 2011 Feb 1.

    PMID: 21277674RESULT

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
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

March 1, 2004

Study Completion

January 1, 2006

Last Updated

December 31, 2014

Record last verified: 2014-12