Trial Condition(s):

Oral Contraceptive

Bleeding pattern study

Bayer Identifier:

91227

ClinicalTrials.gov Identifier:

NCT00302666

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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.

Trial Summary

Enrollment Goal

1315

Trial Dates

June2003

February2005

Phase

Could I receive a placebo?

Products

Valette (Dienogest/EE30, BAY86-5038)

Accepts Healthy Volunteers

Yes

Where to Participate

Locations

Status

Locations	Status
Locations Kreiskrankenhaus Krumbach Krumbach, Germany, 86381	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Praxis Fr. Dr. I. Bayer Berlin, Germany, 10117	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Frauenarztpraxis Hr. Dr. B. Hamann Berlin, Germany, 13187	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Praxis Fr. Dr. B. Heuberger Berlin, Germany, 12587	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Praxis Hr. Dr. R. Humke Hamburg, Germany, 22041	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Praxis Hr. Dr. Werner Göttker-Schnetmann Frankfurt, Germany, 60322	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Praxis Hr. Dr. P.-D. Kaeufer Kelkheim, Germany, 65779	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Praxis Dr. Larbig Fulda, Germany, 36037	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Praxis Fr. Dr. J. Schmidt-Pich Hannover, Germany, 30159	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Praxis Hr. Dr. M. Laubscher Speyer, Germany, 67346	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Praxis Fr. Dr. C. Burgkhardt Leipzig, Germany, 04299	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Praxis Fr. R. Hellmich Dresden, Germany, 01187	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Praxis Fr. Dr. K. Kopprasch Dresden, Germany, 01169	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Praxis Fr. Dr. A. Münzberger Döbeln, Germany, 04720	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Praxis Hr. Prof. Dr. H.-J. Ahrendt Magdeburg, Germany, 39126	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Praxis Fr. Dr. A. Braune Magdeburg, Germany, 39104	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Praxis Fr. Dr. S. Dreissig Magdeburg, Germany, 39118	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Praxis Fr. A. Heweker Bernburg, Germany, 06406	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Praxis Hr. Dr. R. Etzrodt Gera, Germany, 07545	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Praxis Fr. Dr. S. Krepler Jena, Germany, 07747	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Praxis Fr. Dr. A.Mönch-Hering Kahla, Germany, 07768	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Frauenarztpraxis Fr. Dr. H. Schlegel Saalfeld, Germany, 07318	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Praxis Fr. Dr. J. Wartner Eisenberg, Germany, 07607	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Praxis Hr. Dr. K. Diegritz Eberbach, Germany, 69412	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Frauenarztpraxis Dr. Buchberger Neubiberg, Germany, 85579	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Praxis Hr. Dr. R. Kuett Nürnberg, Germany, 90491	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Praxis Hr. Dr. E. Ranger Höchstadt a. d. Aisch, Germany, 91315	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Praxis Hr. Dr. Karl-Heinz Belling Berlin, Germany, 13086	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Frauenarztpraxis Hr. Dr. H. Lindecke Berlin, Germany, 10247	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Praxis Hr. Dr. D. Rautenberg Hamburg, Germany, 21073	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Frauenarztpraxis Dr. med. Wolfram Brach Dietzenbach, Germany, 63128	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Praxis Dr. Kindt Langen, Germany, 63225	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Praxis Hr. Dr. P. Schwaner Frankfurt, Germany, 65936	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Praxis Fr. Dr. J. Tyagi Mühlheim, Germany, 63165	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Klinikum der Johann Wolfgang Goethe Universität Frankfurt, Germany, 60596	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Praxis Dr. M. Truderung Neustrelitz, Germany, 17235	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Praxis Hr. Dr. K. Greven Hannover, Germany, 30459	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Praxis Hr. Dr. H. Beutnagel Ronnenberg, Germany, 30952	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Praxis Hr. Dr. H. Schreiber Kirchheimbolanden, Germany, 67292	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Praxis Fr. Dr. C. Biesold Leipzig, Germany, 04315	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Praxis Fr. I. Gröger Wurzen, Germany, 04808	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Frauenarztpraxis Dr. Bernd Pittner Leipzig, Germany, 04207	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Praxis Fr. Dr. R. Schneiderat Magdeburg, Germany, 39108	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Praxis Hr. H. Thelen Jessen, Germany, 06917	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Frauenarztpraxis Dr. med. Gabriele Weinreich Magdeburg, Germany, 39130	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Frauenarztpraxis Dr. Wetzel Blankenburg, Germany, 38889	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Praxis Hr. R. Wähnert Gera, Germany, 07545	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Praxis Hr. Dr. A. H. Alashkar Gevelsberg, Germany, 58285	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Praxis Fr. Dr. K. Demandt Gütersloh, Germany, 33330	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available

Trial Design

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

Trial Type:

Interventional

Intervention Type:

Drug

Trial Purpose:

Prevention

Allocation:

Randomized

Blinding:

Open Label

Assignment:

Parallel Assignment

Trial Arms:

Primary Outcome

Bleeding pattern
Timeframe:

Secondary Outcome

Safety, contraceptive efficacy
Timeframe:

Oral Contraceptive

Bayer Identifier:

ClinicalTrials.gov Identifier:

EudraCT Number:

Trial Purpose

Key Participation Requirements

sex

age

18 Years

40 Years

Inclusion Criteria

Exclusion Criteria

Inclusion Criteria

Exclusion Criteria

Trial Summary

Enrollment Goal

Trial Dates

Phase

Could I receive a placebo?

Products

Accepts Healthy Volunteers

Where to Participate

Trial Design

Primary Outcome

Secondary Outcome

Additional Information