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Metabolism Study to Investigate the Impact of a Sequential Oral Contraceptive

NCT ID: NCT00185224

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

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2006-03-31

Brief Summary

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The purpose of this study is to confirm the safety of SH T00658ID with regard to plasma lipids, hemostatic variables, and carbohydrate metabolism. In addition, the pharmacokinetic parameter following the long term administration of SH T00658ID will be assessed.

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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

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

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

Intervention Type DRUG

7 treatment cycles of 28 days each (no tablet-free intervals); Days 1-2: 3.0 mg EV; Days 3-7: 2.0 mg EV + 2.0 mg DNG; Days 8-24: 2.0 mg EV + 3.0 mg DNG; Days 25-26: 1.0 mg EV; Days 27 - 28: Placebo

Arm 2

Group Type ACTIVE_COMPARATOR

SH D00264A (Triquilar)

Intervention Type DRUG

7 treatment cycles of 28 days each (no tablet-free intervals);Days 1-6: 0.03 mg EE + 0.05 mg LNG; Days 7-11: 0.04 mg EE + 0.075 mg LNG; Days 12-21: 0.03 mg EE + 0.125 mg LNG;Days 22-28: Placebo

Interventions

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

7 treatment cycles of 28 days each (no tablet-free intervals); Days 1-2: 3.0 mg EV; Days 3-7: 2.0 mg EV + 2.0 mg DNG; Days 8-24: 2.0 mg EV + 3.0 mg DNG; Days 25-26: 1.0 mg EV; Days 27 - 28: Placebo

Intervention Type DRUG

SH D00264A (Triquilar)

7 treatment cycles of 28 days each (no tablet-free intervals);Days 1-6: 0.03 mg EE + 0.05 mg LNG; Days 7-11: 0.04 mg EE + 0.075 mg LNG; Days 12-21: 0.03 mg EE + 0.125 mg LNG;Days 22-28: Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy female volunteers between 18 and 50 years requiring contraception

Exclusion Criteria

* Pregnancy or lactation
* Any conditions that might interfere with the outcome as well as all contraindications for OC use
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 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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Bayer Schering Pharma AG - Clin. Pharm. Berlin

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

References

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Junge W, Mellinger U, Parke S, Serrani M. Metabolic and haemostatic effects of estradiol valerate/dienogest, a novel oral contraceptive: a randomized, open-label, single-centre study. Clin Drug Investig. 2011;31(8):573-584. doi: 10.2165/11590220-000000000-00000.

Reference Type DERIVED
PMID: 21721593 (View on PubMed)

Other Identifiers

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EudraCT: 2004-001614-13

Identifier Type: -

Identifier Source: secondary_id

301886

Identifier Type: -

Identifier Source: secondary_id

90927

Identifier Type: -

Identifier Source: org_study_id

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