Study Completed

Contraception

Bayer Identifier:

90883

ClinicalTrials.gov Identifier:

NCT00185367

EudraCT Number:

Not Available

EU CT Number:

Not Available

Comparative cycle control Europe

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.

Key Participants Requirements

Sex

Female

Age

18 - 50 Years

Trial summary

Enrollment Goal

798

Trial Dates

March 2005 - September 2006

Phase

Phase 3

Could I Receive a placebo

Products

Natazia/Qlaira (EV/DNG, BAY86-5027)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed	Soukroma gynekologicka ambulance	Ostrava - Zabreh, 70400, Czech Republic
Completed	Soukroma gynekologicka ambulance	Fulnek, 74245, Czech Republic
Completed	Femina Sana s.r.o	Praha, 13000, Czech Republic
Completed	Provozorna Gynekologicka ordinace Dr. Tesar	Praha 10, 109 00, Czech Republic
Completed	Soukroma gynekologicka ambulance	Plzen, 30708, Czech Republic
Completed	Frauenarztpraxis Dr. Buchberger	Neubiberg, 85579, Germany
Completed	Praxis Hr. Dr. R. Kuett	Nürnberg, 90491, Germany
Completed	Praxis Fr. Dr. B. Heuberger	Berlin, 12587, Germany
Completed	Frauenarztpraxis Hr. Dr. H. Lindecke	Berlin, 10247, Germany
Completed	Praxis Hr. Dr. Karl-Heinz Belling	Berlin, 13086, Germany
Completed	Frauenarztpraxis Hr. Dr. B. Hamann	Berlin, 13187, Germany
Completed	Praxis Dr. Larbig	Fulda, 36037, Germany
Completed	Praxis Fr. Dr. J. Schmidt-Pich	Hannover, 30159, Germany
Completed	Praxis Hr. Prof. Dr. H.-J. Ahrendt	Magdeburg, 39126, Germany
Completed	Frauenarztpraxis Dr. Wetzel	Blankenburg, 38889, Germany
Completed	Praxis Fr. Dr. A. Braune	Magdeburg, 39104, Germany
Completed	Frauenarztpraxis Dipl. med. Michael Stellmacher	Burg, 39288, Germany
Completed	Praxis Fr. Dr. C. Burgkhardt	Leipzig, 04299, Germany
Completed	Praxis Fr. R. Hellmich	Dresden, 01187, Germany
Completed	Praxis Fr. Dr. K. Kopprasch	Dresden, 01169, Germany
Completed	Praxis Fr. Dr. A. Münzberger	Döbeln, 04720, Germany
Completed	Frauenarztpraxis Dr. Bernd Pittner	Leipzig, 04207, Germany
Completed	Praxis Fr. Dr. A.Mönch-Hering	Kahla, 07768, Germany
Completed	Praxis Hr. R. Wähnert	Gera, 07545, Germany
Completed	Centre Hospitalier de l Estuaire	Honfleur, 14601, France
Completed	Cabinet medical	Quetigny, 21800, France
Completed	Clinique d Occitanie	Muret, 31600, France
Completed	Dr. Marie-Helene Malbranche-Aupecle	Dijon, 21000, France
Completed	Dr. Annette Mercier	Morlaix, 29600, France
Completed	Dr. Jocelyne Nataf-Maurin	Brignoles, 83170, France
Completed	Centre Medical du Val de Loire	Nevers, 58000, France
Completed	Dr. Anne-Isabelle Richet	Paris, 75007, France
Completed	Dr. Gwendoline Servan	TARARE, 69170, France
Completed	Dr. Aliette Siboni-Frisch	Toulouse, 31000, France

Primary Outcome

Bleeding pattern
Time Frame:
7 treatment cycles each consisting of 28 days
Safety Issue:
None
Number of unintended pregnancies
Time Frame:
7 treatment cycles each consisting of 28 days and follow-up period of 14 days
Safety Issue:
None

Secondary Outcome

Adverse event collection
Time Frame:
7 treatment cycles each consisting of 28 days and follow-up period of 14 days
Safety Issue:
None

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

Additional Information

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