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
Phase 3
Completed
- Conditions
- intrauteriene anticonceptieintrauterine contraceptive system
- Registration Number
- NL-OMON36952
- Lead Sponsor
- Bayer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 180
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary variable of this study is the pregnancy rate. The number of<br /><br>pregnancies in both treatment arms will be recorded and PIs with 95 %, 2-sided<br /><br>confidence intervals (CI) will be calculated. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Other variables include, number of IUS expulsions and discontinuations due to<br /><br>(non-)bleeding problems, progestin-related side effects and overall<br /><br>discontinuations will be recorded and their rate calculated.<br /><br><br /><br>In addition to the variables studied in the whole study population, a number of<br /><br>variables will be studied in 4 subsets in (pre)selected centers in Finland.<br /><br>Efficacy evaluations will be conducted in subsets 1 (Ovarian and cervical<br /><br>function studied in 40 subjects) and 2A (Endometrial histology studied in 60<br /><br>subjects), pharmacokinetics in subset 3 and safety in subsets 2B (assessment of<br /><br>hemostatic factors) and 4 (Bone mineral density (BMD) studied in 200 subjects).<br /><br>Note, that the subjects in subsets 2A and 2B are the same individuals.</p><br>