Bleeding Pattern Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00302666
Recruitment Status : Completed
First Posted : March 14, 2006
Last Update Posted : May 18, 2009
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Oral Contraceptive Drug: Valette (Dienogest/EE30, BAY86-5038) Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1315 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : June 2003
Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: Dienogest
U.S. FDA Resources

Arm Intervention/treatment
Sham Comparator: Arm 1 Drug: Valette (Dienogest/EE30, BAY86-5038)
Oral contraceptive extended cycles
Sham Comparator: Arm 2 Drug: Valette (Dienogest/EE30, BAY86-5038)
Oral contraceptive conventional cycles

Primary Outcome Measures :
  1. Bleeding pattern

Secondary Outcome Measures :
  1. Safety, contraceptive efficacy

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00302666

Eberbach, Baden-Württemberg, Germany, 69412
Höchstadt a. d. Aisch, Bayern, Germany, 91315
Krumbach, Bayern, Germany, 86381
Neubiberg, Bayern, Germany, 85579
Nürnberg, Bayern, Germany, 90491
Dietzenbach, Hessen, Germany, 63128
Frankfurt, Hessen, Germany, 60322
Frankfurt, Hessen, Germany, 60596
Frankfurt, Hessen, Germany, 65936
Fulda, Hessen, Germany, 36037
Kelkheim, Hessen, Germany, 65779
Langen, Hessen, Germany, 63225
Mühlheim, Hessen, Germany, 63165
Neustrelitz, Mecklenburg-Vorpommern, Germany, 17235
Hannover, Niedersachsen, Germany, 30159
Hannover, Niedersachsen, Germany, 30459
Ronnenberg, Niedersachsen, Germany, 30952
Gevelsberg, Nordrhein-Westfalen, Germany, 58285
Gütersloh, Nordrhein-Westfalen, Germany, 33330
Kirchheimbolanden, Rheinland-Pfalz, Germany, 67292
Speyer, Rheinland-Pfalz, Germany, 67346
Bernburg, Sachsen-Anhalt, Germany, 06406
Blankenburg, Sachsen-Anhalt, Germany, 38889
Jessen, Sachsen-Anhalt, Germany, 06917
Magdeburg, Sachsen-Anhalt, Germany, 39104
Magdeburg, Sachsen-Anhalt, Germany, 39108
Magdeburg, Sachsen-Anhalt, Germany, 39118
Magdeburg, Sachsen-Anhalt, Germany, 39126
Magdeburg, Sachsen-Anhalt, Germany, 39130
Dresden, Sachsen, Germany, 01169
Dresden, Sachsen, Germany, 01187
Döbeln, Sachsen, Germany, 04720
Leipzig, Sachsen, Germany, 04207
Leipzig, Sachsen, Germany, 04299
Leipzig, Sachsen, Germany, 04315
Wurzen, Sachsen, Germany, 04808
Eisenberg, Thüringen, Germany, 07607
Gera, Thüringen, Germany, 07545
Jena, Thüringen, Germany, 07747
Kahla, Thüringen, Germany, 07768
Saalfeld, Thüringen, Germany, 07318
Berlin, Germany, 10117
Berlin, Germany, 10247
Berlin, Germany, 12587
Berlin, Germany, 13086
Berlin, Germany, 13187
Hamburg, Germany, 21073
Hamburg, Germany, 22041
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Therapeutic Area Head, Bayer Schering Pharma AG Identifier: NCT00302666     History of Changes
Other Study ID Numbers: 91227
First Posted: March 14, 2006    Key Record Dates
Last Update Posted: May 18, 2009
Last Verified: May 2009

Keywords provided by Bayer:
Contraception, Bleeding pattern

Additional relevant MeSH terms:
Pathologic Processes
Contraceptive Agents
Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptive Agents, Male
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents