NCT00302666

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,315

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2003

Geographic Reach
1 country

48 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2006

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 14, 2006

Completed
Last Updated

May 18, 2009

Status Verified

May 1, 2009

First QC Date

February 23, 2006

Last Update Submit

May 15, 2009

Conditions

Oral Contraceptive

Keywords

Contraception, Bleeding pattern

Outcome Measures

Primary Outcomes (1)

  • Bleeding pattern

Secondary Outcomes (1)

  • Safety, contraceptive efficacy

Study Arms (2)

Arm 1

SHAM COMPARATOR
Drug: Valette (Dienogest/EE30, BAY86-5038)

Arm 2

SHAM COMPARATOR
Drug: Valette (Dienogest/EE30, BAY86-5038)

Interventions

Valette (Dienogest/EE30, BAY86-5038)DRUG

Oral contraceptive extended cycles

Arm 1

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy female volunteers aged between 18 and 40 years requiring contraception.

You may not qualify if:

  • Pregnancy or lactation.
  • Any conditions that might interfere with the outcome as well as all contraindications for OC use.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (48)

Unknown Facility

Eberbach, Baden-Wurttemberg, 69412, Germany

Location

Unknown Facility

Höchstadt A. D. Aisch, Bavaria, 91315, Germany

Location

Unknown Facility

Krumbach, Bavaria, 86381, Germany

Location

Unknown Facility

Neubiberg, Bavaria, 85579, Germany

Location

Unknown Facility

Nuremberg, Bavaria, 90491, Germany

Location

Unknown Facility

Hamburg, Hamburg, 21073, Germany

Location

Unknown Facility

Hamburg, Hamburg, 22041, Germany

Location

Unknown Facility

Dietzenbach, Hesse, 63128, Germany

Location

Unknown Facility

Frankfurt am Main, Hesse, 60322, Germany

Location

Unknown Facility

Frankfurt am Main, Hesse, 60596, Germany

Location

Unknown Facility

Frankfurt am Main, Hesse, 65936, Germany

Location

Unknown Facility

Fulda, Hesse, 36037, Germany

Location

Unknown Facility

Kelkheim, Hesse, 65779, Germany

Location

Unknown Facility

Langen, Hesse, 63225, Germany

Location

Unknown Facility

Mühlheim am Main, Hesse, 63165, Germany

Location

Unknown Facility

Hanover, Lower Saxony, 30159, Germany

Location

Unknown Facility

Hanover, Lower Saxony, 30459, Germany

Location

Unknown Facility

Ronnenberg, Lower Saxony, 30952, Germany

Location

Unknown Facility

Neustrelitz, Mecklenburg-Vorpommern, 17235, Germany

Location

Unknown Facility

Gevelsberg, North Rhine-Westphalia, 58285, Germany

Location

Unknown Facility

Gütersloh, North Rhine-Westphalia, 33330, Germany

Location

Unknown Facility

Kirchheimbolanden, Rhineland-Palatinate, 67292, Germany

Location

Unknown Facility

Speyer, Rhineland-Palatinate, 67346, Germany

Location

Unknown Facility

Döbeln, Saxony, 04720, Germany

Location

Unknown Facility

Dresden, Saxony, 01169, Germany

Location

Unknown Facility

Dresden, Saxony, 01187, Germany

Location

Unknown Facility

Leipzig, Saxony, 04207, Germany

Location

Unknown Facility

Leipzig, Saxony, 04299, Germany

Location

Unknown Facility

Leipzig, Saxony, 04315, Germany

Location

Unknown Facility

Wurzen, Saxony, 04808, Germany

Location

Unknown Facility

Bernburg, Saxony-Anhalt, 06406, Germany

Location

Unknown Facility

Blankenburg, Saxony-Anhalt, 38889, Germany

Location

Unknown Facility

Jessen, Saxony-Anhalt, 06917, Germany

Location

Unknown Facility

Magdeburg, Saxony-Anhalt, 39104, Germany

Location

Unknown Facility

Magdeburg, Saxony-Anhalt, 39108, Germany

Location

Unknown Facility

Magdeburg, Saxony-Anhalt, 39118, Germany

Location

Unknown Facility

Magdeburg, Saxony-Anhalt, 39126, Germany

Location

Unknown Facility

Magdeburg, Saxony-Anhalt, 39130, Germany

Location

Unknown Facility

Berlin, State of Berlin, 10117, Germany

Location

Unknown Facility

Berlin, State of Berlin, 10247, Germany

Location

Unknown Facility

Berlin, State of Berlin, 12587, Germany

Location

Unknown Facility

Berlin, State of Berlin, 13086, Germany

Location

Unknown Facility

Berlin, State of Berlin, 13187, Germany

Location

Unknown Facility

Eisenberg, Thuringia, 07607, Germany

Location

Unknown Facility

Gera, Thuringia, 07545, Germany

Location

Unknown Facility

Jena, Thuringia, 07747, Germany

Location

Unknown Facility

Kahla, Thuringia, 07768, Germany

Location

Unknown Facility

Saalfeld, Thuringia, 07318, Germany

Location

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 23, 2006

First Posted

March 14, 2006

Study Start

June 1, 2003

Study Completion

February 1, 2005

Last Updated

May 18, 2009

Record last verified: 2009-05

Locations

DE(48)