check_circleStudy Completed

Contraception

Bayer Identifier:

91313

ClinicalTrials.gov Identifier:

NCT00220324

EudraCT Number:

Not Available

EU CT Number:

Not Available
Pearl Index study with low dose combined oral contraceptive

Trial purpose

The purpose of this study is to investigate the contraceptive efficacy, bleeding pattern, and safety of SH D00342A. Subjects participating in the study will be treated with an oral contraceptive pill containing 0.03 mg ethinylestradiol and 0.125 mg levonorgestrel.

Key Participants Requirements

Sex

Female

Age

18 - 40 Years
  • - Healthy women requiring contraception
  • - Pregnant or lactating women, history or suspicion of hormone dependent tumor or any other conditions which forbid the participation.

Trial summary

Enrollment Goal
840
Trial Dates
February 2004 - November 2005
Phase
Phase 3
Could I Receive a placebo
No
Products
Minisiston/Monostep (EE30/LNG, BAY86-4977)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Frauenarztpraxis Fr. Dr. N. ReichBerlin, 10179, Germany
Completed
Frauenarztpraxis Hr. Dr. G. MerderBerlin, 10247, Germany
Completed
Frauenarztpraxis Fr. Dr. Susanne PlettigBerlin, 10409, Germany
Completed
Praxis Fr. Dr. J. Schmidt-PichHannover, 30159, Germany
Completed
Praxis Fr. Dr. G. GollnickDresden, 01099, Germany
Completed
Praxis Fr. R. DziamborDresden, 01108, Germany
Completed
Frauenarztpraxis Dr. Sven HildebrandtDresden, 01324, Germany
Completed
Frauenarztpraxis Dr. Bernd PittnerLeipzig, 04207, Germany
Completed
Praxis Fr. Dr. G. QuickLeipzig, 04279, Germany
Completed
Praxis Fr. Dr. C. HösemannGroßpösna, 04463, Germany
Completed
Praxis Hr. H. ThelenJessen, 06917, Germany
Completed
Praxis Fr. Dr. K. MüllerAschersleben, 06449, Germany
Completed
Praxis Hr. Dr. B. GereckeHalberstadt, 38821, Germany
Completed
Praxis Fr. Dr. E. SchwarzenauMagdeburg, 39112, Germany
Completed
Praxis Fr. Dr. R. GuentherMagdeburg, 39120, Germany
Completed
Frauenarztpraxis Fr. Dr. S. GramatteBerlin, 12435, Germany
Completed
Praxis Fr. Dr. I. HannigBerlin, 12435, Germany
Completed
Praxis Fr. Dr. K. MaarBerlin, 13507, Germany
Completed
Praxis Fr. E. GotzmannDresden, 01067, Germany
Completed
Praxis Fr. Dr. U. SchlenkDresden, 01324, Germany
Completed
Frauenarztpraxis Fr. Dr. Ulrike KriegLeipzig, 04207, Germany
Completed
Praxis Fr. Dr. G. FörsterLeipzig, 04277, Germany
Completed
Praxis Fr. Dr. C. VoitlAschersleben, 06449, Germany
Completed
Praxis Fr. Dr. A. PrellHalberstadt, 38820, Germany
Completed
Praxis Fr. Dr. B. SchraderHalberstadt, 38820, Germany
Completed
Praxis Hr. Prof. Dr. H.-J. AhrendtMagdeburg, 39126, Germany
Completed
Frauenarztpraxis Hr. Dr. Bernd HennigBurg, 39288, Germany
Completed
Frauenarztpraxis Dipl. med. Michael StellmacherBurg, 39288, Germany
Completed
Frauenarztpraxis Dipl. med. Elke LeidenfrostWeida, 07579, Germany
Completed
Praxis Fr. Dr. B. HauckSuhl, 98527, Germany
Completed
Praxis Fr. Dr. K. ZettlEgeln, 39435, Germany

Primary Outcome

  • Unadjusted Pearl Index
    date_rangeTime Frame:
    After 13 cycles of intake
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Adjusted Pearl Index
    date_rangeTime Frame:
    After 13 cycles of intake
    enhanced_encryption
    Safety Issue:
    no
  • Cumulative pregnancy rate
    date_rangeTime Frame:
    After 13 cycles of intake
    enhanced_encryption
    Safety Issue:
    No
  • Bleeding pattern
    date_rangeTime Frame:
    After 13 cycles of intake
    enhanced_encryption
    Safety Issue:
    No
  • Cycle control
    date_rangeTime Frame:
    After 13 cycles of intake
    enhanced_encryption
    Safety Issue:
    No

Trial design

Prospective, multicenter, open-label, uncontrolled study to investigate the contraceptive efficacy, bleeding patterns, and safety of an oral contraceptive containing 0.03 mg ethinylestradiol and 0.125 mg levonorgestrel (SH D00342A) applied for 13 cycles to healthy female volunteers
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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