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Impact of SH T00658ID as Compared to a Monophasic Contraceptive Containing Ethinylestradiol and Levonorgestrel (SH D01155E) on Hemostatic Parameters

NCT ID: NCT00318799

Last Updated: 2013-11-25

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

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2007-05-31

Brief Summary

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The aim of this study is to evaluate the impact of SH T00658ID (EV/DNG tablet) on hemostatic parameters in comparison to a reference oral contraceptive (OC) (SH D01155E) in a crossover design.

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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Pregnancy, Unplanned

Keywords

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prevention of unintended pregnancies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

EV/DNG (Qlaira, BAY86-5027, SH T00658ID)

Intervention Type DRUG

per cycle (28 days): Days 1-2: 3.0 mg EV; Days 3-7: 2.0 mg EV + 2.0 mg DNG; Days 824: 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 D01155E

Intervention Type DRUG

per cycle: Days 1-21: 0.03 mg EE + 0.15 mg LNG; Days 22-28: Placebo

Interventions

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EV/DNG (Qlaira, BAY86-5027, SH T00658ID)

per cycle (28 days): Days 1-2: 3.0 mg EV; Days 3-7: 2.0 mg EV + 2.0 mg DNG; Days 824: 2.0 mg EV + 3.0 mg DNG; Days 25-26: 1.0 mg EV; Days 27-28: Placebo

Intervention Type DRUG

SH D01155E

per cycle: Days 1-21: 0.03 mg EE + 0.15 mg LNG; Days 22-28: Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy female volunteers

Exclusion Criteria

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

18 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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Dinox B.V.

Groningen, , Netherlands

Site Status

Countries

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Netherlands

References

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Klipping C, Duijkers I, Parke S, Mellinger U, Serrani M, Junge W. Hemostatic effects of a novel estradiol-based oral contraceptive: an open-label, randomized, crossover study of estradiol valerate/dienogest versus ethinylestradiol/levonorgestrel. Drugs R D. 2011;11(2):159-70. doi: 10.2165/11591200-000000000-00000.

Reference Type RESULT
PMID: 21679006 (View on PubMed)

Other Identifiers

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2005-004688-45

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

310122

Identifier Type: OTHER

Identifier Source: secondary_id

91477

Identifier Type: -

Identifier Source: org_study_id