check_circleStudy Completed

Contraception

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

  • - Healthy female volunteers aged between 18 and 50 years requiring contraception

  • - Pregnancy or lactation
    - Any conditions that might interfere with the outcome as well as all contraindications for OC use

Trial summary

Enrollment Goal
798
Trial Dates
March 2005 - September 2006
Phase
Phase 3
Could I Receive a placebo
No
Products
Natazia/Qlaira (EV/DNG, BAY86-5027)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Soukroma gynekologicka ambulanceOstrava - Zabreh, 70400, Czech Republic
Completed
Soukroma gynekologicka ambulanceFulnek, 74245, Czech Republic
Completed
Femina Sana s.r.oPraha, 13000, Czech Republic
Completed
Provozorna Gynekologicka ordinace Dr. TesarPraha 10, 109 00, Czech Republic
Completed
Soukroma gynekologicka ambulancePlzen, 30708, Czech Republic
Completed
Frauenarztpraxis Dr. BuchbergerNeubiberg, 85579, Germany
Completed
Praxis Hr. Dr. R. KuettNürnberg, 90491, Germany
Completed
Praxis Fr. Dr. B. HeubergerBerlin, 12587, Germany
Completed
Frauenarztpraxis Hr. Dr. H. LindeckeBerlin, 10247, Germany
Completed
Praxis Hr. Dr. Karl-Heinz BellingBerlin, 13086, Germany
Completed
Frauenarztpraxis Hr. Dr. B. HamannBerlin, 13187, Germany
Completed
Praxis Dr. LarbigFulda, 36037, Germany
Completed
Praxis Fr. Dr. J. Schmidt-PichHannover, 30159, Germany
Completed
Praxis Hr. Prof. Dr. H.-J. AhrendtMagdeburg, 39126, Germany
Completed
Frauenarztpraxis Dr. WetzelBlankenburg, 38889, Germany
Completed
Praxis Fr. Dr. A. BrauneMagdeburg, 39104, Germany
Completed
Frauenarztpraxis Dipl. med. Michael StellmacherBurg, 39288, Germany
Completed
Praxis Fr. Dr. C. BurgkhardtLeipzig, 04299, Germany
Completed
Praxis Fr. R. HellmichDresden, 01187, Germany
Completed
Praxis Fr. Dr. K. KoppraschDresden, 01169, Germany
Completed
Praxis Fr. Dr. A. MünzbergerDöbeln, 04720, Germany
Completed
Frauenarztpraxis Dr. Bernd PittnerLeipzig, 04207, Germany
Completed
Praxis Fr. Dr. A.Mönch-HeringKahla, 07768, Germany
Completed
Praxis Hr. R. WähnertGera, 07545, Germany
Completed
Centre Hospitalier de l EstuaireHonfleur, 14601, France
Completed
Cabinet medicalQuetigny, 21800, France
Completed
Clinique d OccitanieMuret, 31600, France
Completed
Dr. Marie-Helene Malbranche-AupecleDijon, 21000, France
Completed
Dr. Annette MercierMorlaix, 29600, France
Completed
Dr. Jocelyne Nataf-MaurinBrignoles, 83170, France
Completed
Centre Medical du Val de LoireNevers, 58000, France
Completed
Dr. Anne-Isabelle RichetParis, 75007, France
Completed
Dr. Gwendoline ServanTARARE, 69170, France
Completed
Dr. Aliette Siboni-FrischToulouse, 31000, France

Primary Outcome

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

Secondary Outcome

  • Adverse event collection
    date_rangeTime Frame:
    7 treatment cycles each consisting of 28 days and follow-up period of 14 days
    enhanced_encryption
    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
2