Trial Condition(s):
Contraception
Comparative cycle control Europe
Bayer Identifier:
90883
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Soukroma gynekologicka ambulance Ostrava - Zabreh, Czech Republic, 70400 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Soukroma gynekologicka ambulance Fulnek, Czech Republic, 74245 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Femina Sana s.r.o Praha, Czech Republic, 13000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Provozorna Gynekologicka ordinace Dr. Tesar Praha 10, Czech Republic, 109 00 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Soukroma gynekologicka ambulance Plzen, Czech Republic, 30708 | 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 Fr. Dr. B. Heuberger Berlin, Germany, 12587 | 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. Karl-Heinz Belling Berlin, Germany, 13086 | 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 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. Prof. Dr. H.-J. Ahrendt Magdeburg, Germany, 39126 | 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 Fr. Dr. A. Braune Magdeburg, Germany, 39104 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Frauenarztpraxis Dipl. med. Michael Stellmacher Burg, Germany, 39288 | 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 Frauenarztpraxis Dr. Bernd Pittner Leipzig, Germany, 04207 | 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 Praxis Hr. R. Wähnert Gera, Germany, 07545 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Hospitalier de l Estuaire Honfleur, France, 14601 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cabinet medical Quetigny, France, 21800 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinique d Occitanie Muret, France, 31600 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Marie-Helene Malbranche-Aupecle Dijon, France, 21000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Annette Mercier Morlaix, France, 29600 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Jocelyne Nataf-Maurin Brignoles, France, 83170 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Medical du Val de Loire Nevers, France, 58000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Anne-Isabelle Richet Paris, France, 75007 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Gwendoline Servan TARARE, France, 69170 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Aliette Siboni-Frisch Toulouse, France, 31000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Prevention
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Bleeding patternTimeframe: 7 treatment cycles each consisting of 28 days
- Number of unintended pregnanciesTimeframe: 7 treatment cycles each consisting of 28 days and follow-up period of 14 days
Secondary Outcome
- Adverse event collectionTimeframe: 7 treatment cycles each consisting of 28 days and follow-up period of 14 days
Additional Information
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