Multi-center, single-arm study to assess the safety, efficacy, discontinuation rate and pharmacokinetics of the low-dose levonorgestrel intrauterine contraceptive system (LCS12) in post-menarcheal female adolescents under 18 years of age for 1 year, and an optional 2-year extension phase
- Conditions
- intrauterine anticonceptieintrauterine system as a contraceptiveprevention of pregnancy
- Registration Number
- NL-OMON40073
- Lead Sponsor
- Bayer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 96
- The subject has signed and dated the informed consent form.
- The subject is a female adolescent, generally healthy, post-menarcheal, nulliparous or parous requiring contraception and is under 18 years of age at screening visit.
- The subject has regular menstrual cycles without hormonal contraceptive use (at regular intervals of 21-35 days).
- In the opinion of the investigator, the subject has general and uterine conditions suitable for the insertion of LCS12 (uterine sound depth 6-10cm).
- The subject has clinically normal safety laboratory results.
- The subject has a normal or clinically insignificant cervical smear (i.e. one that does not require further follow up according to Bethesda or a comparable system).
- The subject is willing and able to attend the scheduled study visits and to comply with the study procedures
- Known or suspected pregnancy or is lactating.
- Vaginal delivery, cesarean delivery, or abortion less than 6 weeks before Visit 1.
- Historic of ectopic pregnancies.
- Infected abortion or postpartum endometritis less than 3 months before Visit 1.
- Abnormal uterine bleeding of unknown origin.
- Any lower genital tract infection (until successfully treated).
- Acute or history of recurrent pelvic inflammatory disease.
- Congenital or acquired uterine anomaly.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1) Number of adverse events reported by study subjects 2) Portion of subjects<br /><br>reporting adverse events</p><br>
- Secondary Outcome Measures
Name Time Method <p>1) Overall satisfaction rating from 1 to 5 (from very satisfied to very<br /><br>dissatisfied)<br /><br>2) Pearl Index<br /><br>3) Bleeding patterns collected from patients' diary<br /><br>4) Concentration of levonorgestrel in serum<br /><br>5) Concentration of sex hormone binding globulin in serum<br /><br>6) Discontinuation rate</p><br>