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
2 other identifiers
interventional
304
8 countries
41
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2011
Typical duration for phase_3
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 13, 2011
CompletedFirst Posted
Study publicly available on registry
September 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedJuly 27, 2015
July 1, 2015
1.8 years
September 13, 2011
July 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of adverse events reported by study subjects
12 months treatment period
Portion of subjects reporting adverse events
12 months treatment period
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (1)
Arm 1
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (41)
Unknown Facility
Sankt Pölten, Lower Austria, 3100, Austria
Unknown Facility
Bregenz, 6900, Austria
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Vienna, 1070, Austria
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Voitsberg, 8570, Austria
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Zeltweg, 8740, Austria
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Antwerp, 2018, Belgium
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Bruxelles - Brussel, 1020, Belgium
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Bruxelles - Brussel, 1090, Belgium
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Charleroi, 6000, Belgium
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Leuven, 3000, Belgium
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Århus C, DK-8000, Denmark
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København NV, DK-2400, Denmark
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København S, 2300, Denmark
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Helsinki, 00100, Finland
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Helsinki, 00610, Finland
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Kuopio, 70110, Finland
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Oulu, 90100, Finland
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Oulu, 90220, Finland
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Erlangen, Bavaria, 91054, Germany
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Hamburg, Hamburg, 21073, Germany
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Hamburg, Hamburg, 22587, Germany
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Cologne, North Rhine-Westphalia, 50931, Germany
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Geseke, North Rhine-Westphalia, 59590, Germany
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Dippoldiswalde, Saxony, 01744, Germany
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Dresden, Saxony, 01169, Germany
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Leipzig, Saxony, 04207, Germany
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Leipzig, Saxony, 04299, Germany
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Blankenburg, Saxony-Anhalt, 38889, Germany
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Alkmaar, 1817 MS, Netherlands
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Almere Stad, Netherlands
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Den Helder, 1780 AT, Netherlands
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Enschede, Netherlands
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Heerlen, Netherlands
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Nieuwegein, 3435 CM, Netherlands
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Tilburg, Netherlands
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Fornebu, 1364, Norway
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Sellebakk, 1653, Norway
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Gothenburg, 411 18, Sweden
Unknown Facility
Stockholm, 118 83, Sweden
Unknown Facility
Stockholm, 171 76, Sweden
Unknown Facility
Uppsala, 75185, Sweden
Related Publications (1)
Gemzell-Danielsson K, Buhling KJ, Dermout SM, Lukkari-Lax E, Montegriffo E, Apter D. A Phase III, single-arm study of LNG-IUS 8, a low-dose levonorgestrel intrauterine contraceptive system (total content 13.5mg) in postmenarcheal adolescents. Contraception. 2016 Jun;93(6):507-12. doi: 10.1016/j.contraception.2016.02.004. Epub 2016 Feb 9.
PMID: 26872720DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2011
First Posted
September 14, 2011
Study Start
September 1, 2011
Primary Completion
June 1, 2013
Study Completion
May 1, 2015
Last Updated
July 27, 2015
Record last verified: 2015-07