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Bleeding Pattern Study

Primary Purpose

Oral Contraceptive

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Valette (Dienogest/EE30, BAY86-5038)
Valette (Dienogest/EE30, BAY86-5038)
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oral Contraceptive focused on measuring Contraception, Bleeding pattern

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Healthy female volunteers aged between 18 and 40 years requiring contraception. Exclusion Criteria: Pregnancy or lactation. Any conditions that might interfere with the outcome as well as all contraindications for OC use.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Sham Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

Bleeding pattern

Secondary Outcome Measures

Safety, contraceptive efficacy

Full Information

First Posted
February 23, 2006
Last Updated
May 15, 2009
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00302666
Brief Title
Bleeding Pattern Study
Official Title
Comparative, Prospective, Multi-Center, Open, Randomized Study to Investigate Bleeding Patterns, Metabolic Effects, Contraceptive Efficacy, Acceptance, and Safety of an Oral Contraceptive Containing 0.03 mg Ethinylestradiol and 2 mg Dienogest, in Two Different Regimens of Intake (Four Extended Cycles of 84 Days Each Versus the Conventional Regimen of 21 Days) in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bayer

4. Oversight

5. Study Description

Brief Summary
The aim of this study is to evaluate bleeding pattern, cycle control, contraceptive efficacy and safety of this oral contraceptive in two different regimens of intake.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Contraceptive
Keywords
Contraception, Bleeding pattern

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1315 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Sham Comparator
Arm Title
Arm 2
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
Valette (Dienogest/EE30, BAY86-5038)
Intervention Description
Oral contraceptive extended cycles
Intervention Type
Drug
Intervention Name(s)
Valette (Dienogest/EE30, BAY86-5038)
Intervention Description
Oral contraceptive conventional cycles
Primary Outcome Measure Information:
Title
Bleeding pattern
Secondary Outcome Measure Information:
Title
Safety, contraceptive efficacy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy female volunteers aged between 18 and 40 years requiring contraception. Exclusion Criteria: Pregnancy or lactation. Any conditions that might interfere with the outcome as well as all contraindications for OC use.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Eberbach
State/Province
Baden-Württemberg
ZIP/Postal Code
69412
Country
Germany
City
Höchstadt a. d. Aisch
State/Province
Bayern
ZIP/Postal Code
91315
Country
Germany
City
Krumbach
State/Province
Bayern
ZIP/Postal Code
86381
Country
Germany
City
Neubiberg
State/Province
Bayern
ZIP/Postal Code
85579
Country
Germany
City
Nürnberg
State/Province
Bayern
ZIP/Postal Code
90491
Country
Germany
City
Dietzenbach
State/Province
Hessen
ZIP/Postal Code
63128
Country
Germany
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60322
Country
Germany
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60596
Country
Germany
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
65936
Country
Germany
City
Fulda
State/Province
Hessen
ZIP/Postal Code
36037
Country
Germany
City
Kelkheim
State/Province
Hessen
ZIP/Postal Code
65779
Country
Germany
City
Langen
State/Province
Hessen
ZIP/Postal Code
63225
Country
Germany
City
Mühlheim
State/Province
Hessen
ZIP/Postal Code
63165
Country
Germany
City
Neustrelitz
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
17235
Country
Germany
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30159
Country
Germany
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30459
Country
Germany
City
Ronnenberg
State/Province
Niedersachsen
ZIP/Postal Code
30952
Country
Germany
City
Gevelsberg
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
58285
Country
Germany
City
Gütersloh
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
33330
Country
Germany
City
Kirchheimbolanden
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67292
Country
Germany
City
Speyer
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67346
Country
Germany
City
Bernburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06406
Country
Germany
City
Blankenburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
38889
Country
Germany
City
Jessen
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06917
Country
Germany
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39104
Country
Germany
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39108
Country
Germany
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39118
Country
Germany
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39126
Country
Germany
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39130
Country
Germany
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01169
Country
Germany
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01187
Country
Germany
City
Döbeln
State/Province
Sachsen
ZIP/Postal Code
04720
Country
Germany
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04207
Country
Germany
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04299
Country
Germany
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04315
Country
Germany
City
Wurzen
State/Province
Sachsen
ZIP/Postal Code
04808
Country
Germany
City
Eisenberg
State/Province
Thüringen
ZIP/Postal Code
07607
Country
Germany
City
Gera
State/Province
Thüringen
ZIP/Postal Code
07545
Country
Germany
City
Jena
State/Province
Thüringen
ZIP/Postal Code
07747
Country
Germany
City
Kahla
State/Province
Thüringen
ZIP/Postal Code
07768
Country
Germany
City
Saalfeld
State/Province
Thüringen
ZIP/Postal Code
07318
Country
Germany
City
Berlin
ZIP/Postal Code
10117
Country
Germany
City
Berlin
ZIP/Postal Code
10247
Country
Germany
City
Berlin
ZIP/Postal Code
12587
Country
Germany
City
Berlin
ZIP/Postal Code
13086
Country
Germany
City
Berlin
ZIP/Postal Code
13187
Country
Germany
City
Hamburg
ZIP/Postal Code
21073
Country
Germany
City
Hamburg
ZIP/Postal Code
22041
Country
Germany

12. IPD Sharing Statement

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Bleeding Pattern Study

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