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Study to Evaluate the Effect of Six Cycles of Treatment With a Combined Oral Contraceptive (EE 0.30 mg/DRSP 3 mg) on Quality of Life.

NCT ID: NCT00367276

Last Updated: 2013-10-11

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

221 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2004-05-31

Brief Summary

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

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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Healthy

Keywords

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Females requiring contraceptives

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

* No Contraindication for OC use
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

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

Other Identifiers

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305545

Identifier Type: -

Identifier Source: secondary_id

91070

Identifier Type: -

Identifier Source: org_study_id