LCS12 Adolescent Study

Study Overview
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Brief Summary
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The study will assess the safety of a sex hormone (levonorgestrel) releasing T-shaped intrauterine contraceptive system in female adolescents under 18 years of age. Approximately 300 generally healthy, post-menarcheal female adolescents with regular menses at the beginning of the study requiring contraception will be enrolled into the study. Duration of study treatment is approximately 12 months with an option to continue the use of the contraceptive system up to three years if the woman is willing to continue the use after the first 12 months. The incidence of adverse events over 12 month treatment period will be the main outcome of this study. Also the efficacy (number of pregnancies), discontinuation rate and pharmacokinetics will be evaluated.

Official Title
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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
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Contraception

Intervention / Treatment
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* Drug: Skyla (Levonorgestrel, BAY86-5028)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject has signed and dated the informed consent form (ICF) The subject is female, generally healthy, post-menarcheal, nulliparous or parous, requiring contraception, and is under 18 years of age at the 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 levonorgestrel intrauterine contraceptive system (LCS12) (uterine sound depth 6-10 cm) 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 Exclusion Criteria: Known or suspected pregnancy or is lactating Vaginal delivery, cesarean delivery, or abortion less than 6 weeks before Visit 1 History 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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Skyla (Levonorgestrel, BAY86-5028)<br>* Levonorgestrel intrauterine contraceptive system (LCS12) insertion into the uterus at insertion visit 2 with the study treatment of 12 months. An optional follow up phase up to 3 years will be offered for all subjects completing 12 month treatment time.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events reported by study subjects |  | 12 months treatment period | 
| Portion of subjects reporting adverse events |  | 12 months treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall satisfaction rating from 1 to 5 (from very satisfied to very dissatisfied) |  | 12 months treatment period | 
| Pearl index |  | 12 months treatment period | 
| Bleeding patterns collected from patients' diary |  | 12 months treatment period | 
| Concentration of Levonorgestrel in serum |  | At 1, 3, 6, 9 or 12 months | 
| Concentration of sex hormone binding globulin in serum |  | At 1, 3, 6, 9 or 12 months | 
| Discontinuation rate |  | 12 months treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intrauterine, contraception, adolescent