LCS12 Adolescent Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01434160
First received: September 13, 2011
Last updated: July 3, 2014
Last verified: July 2014

September 13, 2011
July 3, 2014
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 ] [ Designated as safety issue: Yes ]
  • Portion of subjects reporting adverse events [ Time Frame: 12 months treatment period ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01434160 on ClinicalTrials.gov Archive Site
  • Overall satisfaction rating from 1 to 5 (from very satisfied to very dissatisfied) [ Time Frame: 12 months treatment period ] [ Designated as safety issue: No ]
  • Pearl index [ Time Frame: 12 months treatment period ] [ Designated as safety issue: No ]
  • Bleeding patterns collected from patients' diary [ Time Frame: 12 months treatment period ] [ Designated as safety issue: No ]
  • Concentration of Levonorgestrel in serum [ Time Frame: At 1, 3, 6, 9 or 12 months ] [ Designated as safety issue: No ]
  • Concentration of sex hormone binding globulin in serum [ Time Frame: At 1, 3, 6, 9 or 12 months ] [ Designated as safety issue: No ]
  • Discontinuation rate [ Time Frame: 12 months treatment period ] [ Designated as safety issue: No ]
Same as current
Not Provided
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
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Contraception
Drug: LCS (Levonorgestrel IUS, 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: LCS (Levonorgestrel IUS, BAY86-5028)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
304
June 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
Female
12 Years to 17 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Denmark,   Finland,   Germany,   Netherlands,   Norway,   Sweden
 
NCT01434160
14371, 2011-002065-37
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
July 2014

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