check_circleStudy Completed

Oral Contraceptive

Bayer Identifier:
91227
ClinicalTrials.gov Identifier:
NCT00302666
EudraCT Number:
Not Available
EU CT Number:
Not Available
Bleeding pattern study

Trial purpose

The aim of this study is to evaluate bleeding pattern, cycle control, contraceptive efficacy and safety of this oral contraceptive in two different regimens of intake.

Key Participants Requirements

Sex

Female

Age

18 - 40 Years
  • - Healthy female volunteers aged between 18 and 40 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
1315
Trial Dates
June 2003 - February 2005
Phase
Phase 3
Could I Receive a placebo
No
Products
Valette (Dienogest/EE30, BAY86-5038)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Kreiskrankenhaus KrumbachKrumbach, 86381, Germany
Completed
Praxis Fr. Dr. I. BayerBerlin, 10117, Germany
Completed
Frauenarztpraxis Hr. Dr. B. HamannBerlin, 13187, Germany
Completed
Praxis Fr. Dr. B. HeubergerBerlin, 12587, Germany
Completed
Praxis Hr. Dr. R. HumkeHamburg, 22041, Germany
Completed
Praxis Hr. Dr. Werner Göttker-SchnetmannFrankfurt, 60322, Germany
Completed
Praxis Hr. Dr. P.-D. KaeuferKelkheim, 65779, Germany
Completed
Praxis Dr. LarbigFulda, 36037, Germany
Completed
Praxis Fr. Dr. J. Schmidt-PichHannover, 30159, Germany
Completed
Praxis Hr. Dr. M. LaubscherSpeyer, 67346, 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
Praxis Hr. Prof. Dr. H.-J. AhrendtMagdeburg, 39126, Germany
Completed
Praxis Fr. Dr. A. BrauneMagdeburg, 39104, Germany
Completed
Praxis Fr. Dr. S. DreissigMagdeburg, 39118, Germany
Completed
Praxis Fr. A. HewekerBernburg, 06406, Germany
Completed
Praxis Hr. Dr. R. EtzrodtGera, 07545, Germany
Completed
Praxis Fr. Dr. S. KreplerJena, 07747, Germany
Completed
Praxis Fr. Dr. A.Mönch-HeringKahla, 07768, Germany
Completed
Frauenarztpraxis Fr. Dr. H. SchlegelSaalfeld, 07318, Germany
Completed
Praxis Fr. Dr. J. WartnerEisenberg, 07607, Germany
Completed
Praxis Hr. Dr. K. DiegritzEberbach, 69412, Germany
Completed
Frauenarztpraxis Dr. BuchbergerNeubiberg, 85579, Germany
Completed
Praxis Hr. Dr. R. KuettNürnberg, 90491, Germany
Completed
Kreiskrankenhaus KrumbachKrumbach, 86381, Germany
Completed
Praxis Hr. Dr. E. RangerHöchstadt a. d. Aisch, 91315, Germany
Completed
Praxis Hr. Dr. E. RangerHöchstadt a. d. Aisch, 91315, Germany
Completed
Praxis Hr. Dr. Karl-Heinz BellingBerlin, 13086, Germany
Completed
Frauenarztpraxis Hr. Dr. H. LindeckeBerlin, 10247, Germany
Completed
Praxis Hr. Dr. D. RautenbergHamburg, 21073, Germany
Completed
Frauenarztpraxis Dr. med. Wolfram BrachDietzenbach, 63128, Germany
Completed
Praxis Dr. KindtLangen, 63225, Germany
Completed
Praxis Hr. Dr. P. SchwanerFrankfurt, 65936, Germany
Completed
Praxis Fr. Dr. J. TyagiMühlheim, 63165, Germany
Completed
Klinikum der Johann Wolfgang Goethe UniversitätFrankfurt, 60596, Germany
Completed
Praxis Dr. M. TruderungNeustrelitz, 17235, Germany
Completed
Praxis Hr. Dr. K. GrevenHannover, 30459, Germany
Completed
Praxis Hr. Dr. H. BeutnagelRonnenberg, 30952, Germany
Completed
Praxis Hr. Dr. H. SchreiberKirchheimbolanden, 67292, Germany
Completed
Praxis Fr. Dr. C. BiesoldLeipzig, 04315, Germany
Completed
Praxis Fr. I. GrögerWurzen, 04808, Germany
Completed
Frauenarztpraxis Dr. Bernd PittnerLeipzig, 04207, Germany
Completed
Praxis Fr. Dr. R. SchneideratMagdeburg, 39108, Germany
Completed
Praxis Hr. H. ThelenJessen, 06917, Germany
Completed
Frauenarztpraxis Dr. med. Gabriele WeinreichMagdeburg, 39130, Germany
Completed
Frauenarztpraxis Dr. WetzelBlankenburg, 38889, Germany
Completed
Praxis Hr. R. WähnertGera, 07545, Germany
Completed
Praxis Hr. Dr. A. H. AlashkarGevelsberg, 58285, Germany
Completed
Praxis Fr. Dr. K. DemandtGütersloh, 33330, Germany

Primary Outcome

  • Bleeding pattern
    enhanced_encryption
    Safety Issue:
    None

Secondary Outcome

  • Safety, contraceptive efficacy
    enhanced_encryption
    Safety Issue:
    None

Trial design

Comparative, prospective, multi-center, open, randomized study to investigate bleeding patterns, metabolic effects, contraceptive efficacy, acceptance, and safety of an oral contraceptive containing 0.03 mg Ethinylestradiol and 2 mg Dienogest, in two different regimens of intake (four extended cycles of 84 days each versus the conventional regimen of 21 days) in healthy volunteers
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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