Bleeding Pattern Study

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00302666
First received: February 23, 2006
Last updated: May 15, 2009
Last verified: May 2009
  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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Bleeding pattern

Secondary Outcome Measures:
  • Safety, contraceptive efficacy

Enrollment: 1315
Study Start Date: June 2003
Study Completion Date: February 2005
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00302666

Locations
Germany
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, 65936
Frankfurt, Hessen, Germany, 60322
Frankfurt, Hessen, Germany, 60596
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, 39126
Magdeburg, Sachsen-Anhalt, Germany, 39118
Magdeburg, Sachsen-Anhalt, Germany, 39108
Magdeburg, Sachsen-Anhalt, Germany, 39104
Magdeburg, Sachsen-Anhalt, Germany, 39130
Dresden, Sachsen, Germany, 01169
Dresden, Sachsen, Germany, 01187
Döbeln, Sachsen, Germany, 04720
Leipzig, Sachsen, Germany, 04299
Leipzig, Sachsen, Germany, 04207
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, 10247
Berlin, Germany, 13187
Berlin, Germany, 10117
Berlin, Germany, 13086
Berlin, Germany, 12587
Hamburg, Germany, 21073
Hamburg, Germany, 22041
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00302666     History of Changes
Other Study ID Numbers: 91227, 306903
Study First Received: February 23, 2006
Last Updated: May 15, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Contraception, Bleeding pattern

Additional relevant MeSH terms:
Contraceptive Agents
Dienogest
Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Contraceptive Agents, Male
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on October 01, 2014