Yasmin 20 Cycle Control - Yasmin 20 Versus Mercilon in Healthy Female Volunteers

NCT ID: NCT00624130

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

453 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2005-06-30

Brief Summary

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The purpose of this study is to compare bleeding pattern of contraceptive Yasmin 20 to a marketed comparator.

Detailed Description

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Conditions

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Contraception

Keywords

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Contraception, Cycle control, Bleeding pattern

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Yasmin 20

Intervention Type DRUG

Yasmin 20, 24-d regimen vs Mercilon, Tablet p.o. (oral)

Arm 2

Group Type ACTIVE_COMPARATOR

Mercilon

Intervention Type DRUG

Mercilon, 24-d regimen vs Yasmin 20 , Tablet p.o. (oral)

Interventions

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Yasmin 20

Yasmin 20, 24-d regimen vs Mercilon, Tablet p.o. (oral)

Intervention Type DRUG

Mercilon

Mercilon, 24-d regimen vs Yasmin 20 , Tablet p.o. (oral)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy female volunteer aged 18-35,
* Smokers 18-30

Exclusion Criteria

* Contraindications for using hormonal contraceptives
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

Locations

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Horn, , Austria

Site Status

Leibnitz, Styria, , Austria

Site Status

Mödling, , Austria

Site Status

Sankt Pölten, , Austria

Site Status

Vienna, , Austria

Site Status

Wörgl, , Austria

Site Status

Pärnu, , Estonia

Site Status

Talinn, , Estonia

Site Status

Tartu, , Estonia

Site Status

Helsinki, , Finland

Site Status

Helsinki, , Finland

Site Status

Tampere, , Finland

Site Status

Turku, , Finland

Site Status

Kaunas, , Lithuania

Site Status

Kaunas, , Lithuania

Site Status

Vilnius, , Lithuania

Site Status

Vilnius, , Lithuania

Site Status

Countries

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Austria Estonia Finland Lithuania

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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308020

Identifier Type: -

Identifier Source: secondary_id

91352

Identifier Type: -

Identifier Source: org_study_id