LCS12 Adolescent Study

Phase 3

Completed

• Conditions: Contraception
• Interventions: Drug: Skyla (Levonorgestrel, BAY86-5028)

• Registration Number: NCT01434160
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-13
• Study First Submitted QC: 2011-09-13
• Study First Posted: 2011-09-14
• Primary Completion: 2013-06
• Study Completion: 2015-05
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-24
• Last Update Posted: 2015-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 304

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Skyla (Levonorgestrel, BAY86-5028)	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Overall satisfaction rating from 1 to 5 (from very satisfied to very dissatisfied)	12 months treatment period
Discontinuation rate	12 months treatment period