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Efficacy and Safety Oral Contraceptive Study

NCT ID: NCT00185484

Last Updated: 2014-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2006-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Contraception

Keywords

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Oral contraception

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

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

Intervention Type 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

Interventions

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

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Any conditions might interfere study outcome
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Countries

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Belgium Czechia Hungary Italy Latvia Slovakia

References

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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.

Reference Type RESULT
PMID: 21721590 (View on PubMed)

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.

Reference Type RESULT
PMID: 21277674 (View on PubMed)

Other Identifiers

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308021

Identifier Type: -

Identifier Source: secondary_id

91353

Identifier Type: -

Identifier Source: org_study_id