NL-OMON36952
Completed
Phase 3
Multi-center, open-label, randomized study to assess the safety and contraceptive efficacy of two doses (in vitro 12 µg/24 h and 16 µg/24 h) of the ultra low dose levonorgestrel contraceptive intrauterine systems (LCS) for a maximum of 3 years in women 18 to 35 years of age with an extension of the LCS16 treatment arm up to five years - LCS
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- intrauteriene anticonceptie
- Sponsor
- Bayer
- Enrollment
- 180
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •has signed informed consent.;is of age between 18 and 35 years (inclusive), in good general health and requesting contraception.;has, in the opinion of the investigator, suitable general and uterine conditions for inserting the LCS.;has clinically normal safety laboratory results (i.e., inside the specified range for inclusion). ;is willing and able to attend the scheduled visits and to comply with the study procedures.;has regular menstrual cycles (length of cycle 21\-35 days) (i.e., endogenous cyclicity without hormonal contraceptive use).
Exclusion Criteria
- •see also section 4\.1\.2 e.g.:;Known or suspected pregnancy or is lactating;History of ectopic pregnancies
Outcomes
Primary Outcomes
Not specified
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