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Trial intelligence / Profile preview
Minisiston for Contraception in Healthy Women
NCT00220324Phase 3
Key facts
- Status
- Completed
- Start
- Feb 2004
- Countries
- 1
- Sponsor
- Bayer
- Modality
- Small Molecules
- Conditions
- pregnancy
01
Overview
Phase 3, open-label, single-arm trial of ethinylestradiol + levonorgestrel in pregnancy, sponsored by Bayer. Primary endpoint: Unadjusted Pearl Index. Started Feb 2004; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Minisiston
Healthy women receiving Minisiston for 13 cycles.
03
Who it enrols
Healthy women requiring contraception, excluding those pregnant, lactating, or with hormone-dependent tumors.
04
Endpoints
Primary
Unadjusted Pearl Index
Secondary
Adjusted Pearl Index
Cumulative Pregnancy Rate
Bleeding Pattern
Cycle Control
Safety
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