check_circleStudy Completed

Contraception

Bayer Identifier:

91450

ClinicalTrials.gov Identifier:

NCT00266032

EudraCT Number:

2005-002125-32

EU CT Number:

Not Available
Study on safety and efficacy of an oral contraceptive in long cycles

Trial purpose

The purpose of the study is to determine safety and efficacy of long-cycle regimens of an oral contraceptive.

Key Participants Requirements

Sex

Female

Age

18 - 35 Years
  • - Healthy women who desire contraception
    - smokers ≤ 30 Years old


  • - Contraindication against use of hormonal contraceptives

Trial summary

Enrollment Goal
1166
Trial Dates
December 2005 - October 2008
Phase
Phase 3
Could I Receive a placebo
No
Products
EE20/DRSP (BAY86-5300)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Praxis Hr. Dr. U. KohoutekKarlsruhe, 76199, Germany
Completed
Kreiskrankenhaus KrumbachKrumbach, 86381, Germany
Completed
Praxis Hr. Dr. L. WeiheAnsbach, 91522, Germany
Completed
Dinox GmbH BerlinBerlin, 10115, Germany
Completed
Frauenarztpraxis Hr. Dr. H. LindeckeBerlin, 10247, Germany
Completed
Praxis Fr. Dr. B. WerneckeBerlin, 12435, Germany
Completed
Frauenarztpraxis Dr. med. Wolfram BrachDietzenbach, 63128, Germany
Completed
Praxis Dr. S. El Tobgui-JensenFrankfurt, 60439, Germany
Completed
Praxis Hr. Dr. Werner Göttker-SchnetmannFrankfurt, 60322, Germany
Completed
Praxis Hr. Dr. P. SchwanerFrankfurt, 65936, Germany
Completed
Praxis Fr. Dr. J. TyagiMühlheim, 63165, Germany
Completed
Praxis Hr. Dr. H. FrommeyerOsnabrück, 49074, Germany
Completed
Praxis Hr. Dr. H. ZabelBovenden, 37120, Germany
Completed
Praxis Hr. H. ThelenJessen, 06917, Germany
Completed
Praxis Hr. Dr. A. SoderEttlingen, 76275, Germany
Completed
Praxis Hr. Dr. R. KuettNürnberg, 90491, Germany
Completed
Kreiskrankenhaus KrumbachKrumbach, 86381, Germany
Completed
Frauenarztpraxis Hr. Dr. B. HamannBerlin, 13187, Germany
Completed
Praxis Hr. Dr. D. RautenbergHamburg, 21073, Germany
Completed
Praxis Dr. S. Clauss-HoffmannFrankfurt, 65929, Germany
Completed
Praxis Hr. Dr. K. GrevenHannover, 30459, Germany
Completed
Praxis Fr. I. GrögerWurzen, 04808, Germany
Completed
Praxis Hr. Prof. Dr. H.-J. AhrendtMagdeburg, 39126, Germany
Completed
Praxis Fr. Dr. A. BrauneMagdeburg, 39104, Germany
Completed
Praxis Fr. A. HewekerBernburg, 06406, Germany
Completed
Praxis Hr. Dr. R. EtzrodtGera, 07545, Germany
Completed
Dinox B.V.Groningen, 9713 GZ, Netherlands
Completed
Clinique Médicale des CampusSte-Foy, G1V 4X7, Canada
Completed
Clinique de GynecologieShawinigan, G9N 2H6, Canada
Completed
Frauenarztpraxis Dr. med. Gabriele WeinreichMagdeburg, 39130, Germany
Completed
Praxis Fr. Dr. S. KreplerJena, 07747, Germany
Completed
Praxis Fr. Dr. A.Mönch-HeringKahla, 07768, Germany
Completed
Praxis Hr. R. WähnertGera, 07545, Germany
Completed
Clinique Recherche en Sante des Femmes Inc.Quebec, G1S 2L6, Canada
Completed
Centre d'étude clinique de Montréal Inc.Montreal, H1T 1P6, Canada
Completed
Rhodin Recherche CliniqueDrummondville, J2B 1H8, Canada
Completed
Kells Medical Research Group, Inc.Pointe-Claire, H9R 4S3, Canada

Primary Outcome

  • Number of days with bleeding including spotting
    date_rangeTime Frame:
    up to 1 year
    enhanced_encryption
    Safety Issue:
    No
  • Number of unintended pregnancies in Yaz flexible arm
    date_rangeTime Frame:
    up to 2 years
    enhanced_encryption
    Safety Issue:
    No
  • Pearl Index
    date_rangeTime Frame:
    Up to 2 years
    enhanced_encryption
    Safety Issue:
    No
  • Number of unintended pregnancies due to method failure
    date_rangeTime Frame:
    Up to 2 years
    enhanced_encryption
    Safety Issue:
    No
  • Adjusted Pearl index
    date_rangeTime Frame:
    Up to 2 years
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of days with bleeding exluding spotting
    date_rangeTime Frame:
    up to 1 year
    enhanced_encryption
    Safety Issue:
    No
  • Number of bleeding days during one year of treatment in subjects with at least 248 days of exposure normalized to 372 days
    date_rangeTime Frame:
    up to 1 year
    enhanced_encryption
    Safety Issue:
    No
  • Number of bleeding / spotting days by 90-day reference period
    date_rangeTime Frame:
    up to 1 year
    enhanced_encryption
    Safety Issue:
    No
  • Number of bleeding / spotting episodes in 90 day reference period
    date_rangeTime Frame:
    Up to one year
    enhanced_encryption
    Safety Issue:
    No
  • Days with scheduled versus unscheduled bleeding
    date_rangeTime Frame:
    Up to one year
    enhanced_encryption
    Safety Issue:
    No

Trial design

A multicenter, open, randomized, parallel group comparison to assess the safety and efficacy of the oral contraceptive SH T00186D (0.02 mg ethinylestradiol as betadex clathrate and 3 mg drospirenone) in two variations of an extended regimen vs. a standard regimen (24 + 4 days) in 1122 healthy female volunteers for one year, followed by a one year safety extension
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
3

Additional Information

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