Contraception Clinical Trial
Official title:
A Multi-center, Double-blind, Double-dummy, Controlled, Randomized Study to Evaluate Cycle Control and Safety of a Four Phasic Oral Contraceptive (SH T00658ID) in Comparison to an Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel (SH D 593 B) in Healthy Female Volunteers Aged Between 18 and 50 Years.
The aim of this study is to evaluate bleeding pattern, cycle control, and safety of this new four-phasic oral contraceptive in comparison to a reference OC.
| Status | Completed |
| Enrollment | 798 |
| Est. completion date | September 2006 |
| Est. primary completion date | |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 50 Years |
| Eligibility |
Inclusion Criteria: - Healthy female volunteers aged between 18 and 50 years requiring contraception Exclusion Criteria: - Pregnancy or lactation - Any conditions that might interfere with the outcome as well as all contraindications for OC use |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Czech Republic | Soukroma gynekologicka ambulance | Fulnek | |
| Czech Republic | Soukroma gynekologicka ambulance | Ostrava - Zabreh | |
| Czech Republic | Soukroma gynekologicka ambulance | Plzen | |
| Czech Republic | Femina Sana s.r.o | Praha | |
| Czech Republic | Provozorna Gynekologicka ordinace Dr. Tesar | Praha 10 | |
| France | Dr. Jocelyne Nataf-Maurin | Brignoles | |
| France | Dr. Marie-Helene Malbranche-Aupecle | Dijon | |
| France | Centre Hospitalier de l Estuaire | Honfleur | |
| France | Dr. Annette Mercier | Morlaix | |
| France | Clinique d Occitanie | Muret | |
| France | Centre Medical du Val de Loire | Nevers | |
| France | Dr. Anne-Isabelle Richet | Paris | |
| France | Cabinet medical | Quetigny | |
| France | Dr. Gwendoline Servan | Tarare | |
| France | Dr. Aliette Siboni-Frisch | Toulouse | |
| Germany | Frauenarztpraxis Hr. Dr. B. Hamann | Berlin | |
| Germany | Frauenarztpraxis Hr. Dr. H. Lindecke | Berlin | |
| Germany | Praxis Fr. Dr. B. Heuberger | Berlin | |
| Germany | Praxis Hr. Dr. Karl-Heinz Belling | Berlin | |
| Germany | Frauenarztpraxis Dr. Wetzel | Blankenburg | Sachsen-Anhalt |
| Germany | Frauenarztpraxis Dipl. med. Michael Stellmacher | Burg | Sachsen-Anhalt |
| Germany | Praxis Fr. Dr. A. Münzberger | Döbeln | Sachsen |
| Germany | Praxis Fr. Dr. K. Kopprasch | Dresden | Sachsen |
| Germany | Praxis Fr. R. Hellmich | Dresden | Sachsen |
| Germany | Praxis Dr. Larbig | Fulda | Hessen |
| Germany | Praxis Hr. R. Wähnert | Gera | Thüringen |
| Germany | Praxis Fr. Dr. J. Schmidt-Pich | Hannover | Niedersachsen |
| Germany | Praxis Fr. Dr. A.Mönch-Hering | Kahla | Thüringen |
| Germany | Frauenarztpraxis Dr. Bernd Pittner | Leipzig | Sachsen |
| Germany | Praxis Fr. Dr. C. Burgkhardt | Leipzig | Sachsen |
| Germany | Praxis Fr. Dr. A. Braune | Magdeburg | Sachsen-Anhalt |
| Germany | Praxis Hr. Prof. Dr. H.-J. Ahrendt | Magdeburg | Sachsen-Anhalt |
| Germany | Frauenarztpraxis Dr. Buchberger | Neubiberg | Bayern |
| Germany | Praxis Hr. Dr. R. Kuett | Nürnberg | Bayern |
| Lead Sponsor | Collaborator |
|---|---|
| Bayer |
Czech Republic, France, Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Bleeding pattern | 7 treatment cycles each consisting of 28 days | ||
| Primary | Number of unintended pregnancies | 7 treatment cycles each consisting of 28 days and follow-up period of 14 days | ||
| Secondary | Adverse event collection | 7 treatment cycles each consisting of 28 days and follow-up period of 14 days |
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