Status:
COMPLETED
Valette (Combined Oral Contraceptive SH T04769G and SH D00659AF) Low Ovulation Inhibition
Lead Sponsor:
Bayer
Conditions:
Oral Contraceptive
Eligibility:
FEMALE
18-35 years
Phase:
PHASE2
Brief Summary
The aim of this monocenter, open-label, randomized study is to determine the ovulation inhibitory effect of the combined oral contraceptive (COC) SH T04769G and to collect supplementary data regarding...
Detailed Description
The trial is sponsored by Bayer Schering Pharma AG, Germany.
Eligibility Criteria
Inclusion
- Healthy female volunteers, aged 18 - 35 years (smokers up to 30 years)
- Willingness to apply non-hormonal methods of contraception during the course of the study (e.g., condom with spermicide, diaphragm with spermicide)
- Confirmation of ovulation during the cycle before treatment
- Normal routine blood values
Exclusion
- Contraindications for the use of oral contraceptives
- Pregnancy, lactation
- Simultaneous participation in another clinical study
- Considerable overweight
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00471991
Start Date
April 1 2007
End Date
December 1 2007
Last Update
January 25 2013
Active Locations (1)
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1
Berlin, State of Berlin, Germany, 10115