Ovulation Inhibition of Two 4-phasic Oral Contraceptive Regimens

NCT ID: NCT00805415

Last Updated: 2011-07-15

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

PHASE2

Total Enrollment

209 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2004-02-29

Brief Summary

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The aim of the study is to investigate the ovulation inhibition of two 4-phasic oral contraceptive regimens.

Detailed Description

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Conditions

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Ovulation Inhibition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

EV/DNG (Qlaira, BAY86-5027, SH T00658K)

Intervention Type DRUG

Estradiol valerate (EV) and dienogest (DNG) in a sequential 4-phasic regimen, EV 3, 2, and 1 mg and DNG 2 and 3 mg

Arm 2

Group Type EXPERIMENTAL

EV/DNG (SH T00658L)

Intervention Type DRUG

Estradiol valerate (EV) and dienogest (DNG) in a sequential 4-phasic regimen, EV 3, 2, and 1 mg and DNG 3 and 4 mg

Interventions

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EV/DNG (Qlaira, BAY86-5027, SH T00658K)

Estradiol valerate (EV) and dienogest (DNG) in a sequential 4-phasic regimen, EV 3, 2, and 1 mg and DNG 2 and 3 mg

Intervention Type DRUG

EV/DNG (SH T00658L)

Estradiol valerate (EV) and dienogest (DNG) in a sequential 4-phasic regimen, EV 3, 2, and 1 mg and DNG 3 and 4 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy women willing to use non-hormonal methods of contraception

Exclusion Criteria

* Women with any contraindication for oral contraceptive use, for example but not limited to: presence or history of venous or arterial thrombotic / thrombembolic events, hypertension, presence or history of severe hepatic disease
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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Bayer Healthcare AG

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Dinox GmbH Berlin

Berlin, State of Berlin, Germany

Site Status

Dinox B.V.

Groningen, , Netherlands

Site Status

Countries

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Germany Netherlands

Other Identifiers

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307300

Identifier Type: -

Identifier Source: secondary_id

91271

Identifier Type: -

Identifier Source: org_study_id

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