Bleeding Pattern Study
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00302666
First received: February 23, 2006
Last updated: May 15, 2009
Last verified: May 2009
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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
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, 39118 | |
| Magdeburg, Sachsen-Anhalt, Germany, 39130 | |
| Magdeburg, Sachsen-Anhalt, Germany, 39108 | |
| Magdeburg, Sachsen-Anhalt, Germany, 39104 | |
| Magdeburg, Sachsen-Anhalt, Germany, 39126 | |
| 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:
|
Hemorrhage Pathologic Processes Contraceptive Agents Dienogest Contraceptives, Oral Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions |
Therapeutic Uses Contraceptive Agents, Female Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Contraceptive Agents, Male |
ClinicalTrials.gov processed this record on May 16, 2013