EUCTR2007-000420-40-HU
Active, not recruiting
Not Applicable
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 - LCS Pearl Index Study
Bayer Schering Pharma Oy0 sites2,820 target enrollmentJuly 4, 2007
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Contraception
- Sponsor
- Bayer Schering Pharma Oy
- Enrollment
- 2820
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Has signed informed consent.
- •2\.Is of age between 18 and 35 years (inclusive), in good general health and requesting contraception.
- •3\.Has, in the opinion of the investigator, suitable general and uterine conditions for inserting the LCS.
- •4\.Has clinically normal safety laboratory results (i.e., inside the specified range for inclusion).
- •5\.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).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
Exclusion Criteria
- •1\.Known or suspected pregnancy or is lactating.
- •2\.Vaginal delivery, cesarean delivery, or abortion within 6 weeks prior to visit 1\.
- •3\.History of ectopic pregnancies.
- •4\.Infected abortion or postpartum endometritis within 3 months prior to visit 1\.
- •5\.Abnormal uterine bleeding of unknown origin.
- •6\.Any genital infection (until successfully treated).
- •7\.Descriptive diagnoses of epithelial cell atypias (not benign atypias) or more serious disorder in cervical smear (according to the Bethesda System) at screening and not responding to treatment.
- •8\.History of, or current, pelvic inflammatory disease.
- •9\.Congenital or acquired uterine anomaly.
- •10\.Any distortion of the uterine cavity (by e.g., fibroids) likely to cause problems (in the opinion of the investigator) during insertion, retention or removal of the LCS.
Outcomes
Primary Outcomes
Not specified
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