Clinical trial NCT00185367: Comparative Cycle Control Europe
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 798
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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 criteria: 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

Primary outcomes:
measure: Bleeding pattern
timeFrame: 7 treatment cycles each consisting of 28 days
measure: Number of unintended pregnancies
timeFrame: 7 treatment cycles each consisting of 28 days and follow-up period of 14 days
Secondary outcomes:
measure: Adverse event collection
timeFrame: 7 treatment cycles each consisting of 28 days and follow-up period of 14 days
Other outcomes:
Locations:
city: Fulnek
country: Czech Republic
facility: Soukroma gynekologicka ambulance
city: Ostrava - Zabreh
country: Czech Republic
facility: Soukroma gynekologicka ambulance
city: Plzen
country: Czech Republic
facility: Soukroma gynekologicka ambulance
city: Praha 10
country: Czech Republic
facility: Provozorna Gynekologicka ordinace Dr. Tesar
city: Praha
country: Czech Republic
facility: Femina Sana s.r.o
city: Brignoles
country: France
facility: Dr. Jocelyne Nataf-Maurin
city: Dijon
country: France
facility: Dr. Marie-Helene Malbranche-Aupecle
city: Honfleur
country: France
facility: Centre Hospitalier de l Estuaire
city: Morlaix
country: France
facility: Dr. Annette Mercier
city: Muret
country: France
facility: Clinique d Occitanie
city: Nevers
country: France
facility: Centre Medical du Val de Loire
city: Paris
country: France
facility: Dr. Anne-Isabelle Richet
city: Quetigny
country: France
facility: Cabinet medical
city: Tarare
country: France
facility: Dr. Gwendoline Servan
city: Toulouse
country: France
facility: Dr. Aliette Siboni-Frisch
city: Neubiberg
country: Germany
facility: Frauenarztpraxis Dr. Buchberger
state: Bayern
city: Nürnberg
country: Germany
facility: Praxis Hr. Dr. R. Kuett
state: Bayern
city: Fulda
country: Germany
facility: Praxis Dr. Larbig
state: Hessen
city: Hannover
country: Germany
facility: Praxis Fr. Dr. J. Schmidt-Pich
state: Niedersachsen
city: Blankenburg
country: Germany
facility: Frauenarztpraxis Dr. Wetzel
state: Sachsen-Anhalt
city: Burg
country: Germany
facility: Frauenarztpraxis Dipl. med. Michael Stellmacher
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
facility: Praxis Fr. Dr. A. Braune
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
facility: Praxis Hr. Prof. Dr. H.-J. Ahrendt
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: Praxis Fr. Dr. K. Kopprasch
state: Sachsen
city: Dresden
country: Germany
facility: Praxis Fr. R. Hellmich
state: Sachsen
city: Döbeln
country: Germany
facility: Praxis Fr. Dr. A. Münzberger
state: Sachsen
city: Leipzig
country: Germany
facility: Frauenarztpraxis Dr. Bernd Pittner
state: Sachsen
city: Leipzig
country: Germany
facility: Praxis Fr. Dr. C. Burgkhardt
state: Sachsen
city: Gera
country: Germany
facility: Praxis Hr. R. Wähnert
state: Thüringen
city: Kahla
country: Germany
facility: Praxis Fr. Dr. A.Mönch-Hering
state: Thüringen
city: Berlin
country: Germany
facility: Frauenarztpraxis Hr. Dr. H. Lindecke
city: Berlin
country: Germany
facility: Praxis Fr. Dr. B. Heuberger
city: Berlin
country: Germany
facility: Praxis Hr. Dr. Karl-Heinz Belling
city: Berlin
country: Germany
facility: Frauenarztpraxis Hr. Dr. B. Hamann
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Ahrendt HJ, Makalova D, Parke S, Mellinger U, Mansour D. Bleeding pattern and cycle control with an estradiol-based oral contraceptive: a seven-cycle, randomized comparative trial of estradiol valerate/dienogest and ethinyl estradiol/levonorgestrel. Contraception. 2009 Nov;80(5):436-44. doi: 10.1016/j.contraception.2009.03.018. Epub 2009 May 13.