LCS12 Adolescent Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01434160
Recruitment Status : Completed
First Posted : September 14, 2011
Last Update Posted : July 27, 2015
Information provided by (Responsible Party):

September 13, 2011
September 14, 2011
July 27, 2015
September 2011
June 2013   (Final data collection date for primary outcome measure)
  • Number of adverse events reported by study subjects [ Time Frame: 12 months treatment period ]
  • Portion of subjects reporting adverse events [ Time Frame: 12 months treatment period ]
Same as current
Complete list of historical versions of study NCT01434160 on Archive Site
  • Overall satisfaction rating from 1 to 5 (from very satisfied to very dissatisfied) [ Time Frame: 12 months treatment period ]
  • Pearl index [ Time Frame: 12 months treatment period ]
  • Bleeding patterns collected from patients' diary [ Time Frame: 12 months treatment period ]
  • Concentration of Levonorgestrel in serum [ Time Frame: At 1, 3, 6, 9 or 12 months ]
  • Concentration of sex hormone binding globulin in serum [ Time Frame: At 1, 3, 6, 9 or 12 months ]
  • Discontinuation rate [ Time Frame: 12 months treatment period ]
Same as current
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Not Provided
LCS12 Adolescent Study
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

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.

Not Provided
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Drug: Skyla (Levonorgestrel, BAY86-5028)
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.
Experimental: Arm 1
Intervention: Drug: Skyla (Levonorgestrel, BAY86-5028)
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2015
June 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
12 Years to 17 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Denmark,   Finland,   Germany,   Netherlands,   Norway,   Sweden
2011-002065-37 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Study Director: Bayer Study Director Bayer
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP