Clinical trial NCT01434160: LCS12 Adolescent Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Keywords: Intrauterine
contraception
adolescent
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-09-14
Enrollment: 304
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of adverse events reported by study subjects
timeFrame: 12 months treatment period
measure: Portion of subjects reporting adverse events
timeFrame: 12 months treatment period
Secondary outcomes:
measure: Overall satisfaction rating from 1 to 5 (from very satisfied to very dissatisfied)
timeFrame: 12 months treatment period
measure: Pearl index
timeFrame: 12 months treatment period
measure: Bleeding patterns collected from patients' diary
timeFrame: 12 months treatment period
measure: Concentration of Levonorgestrel in serum
timeFrame: At 1, 3, 6, 9 or 12 months
measure: Concentration of sex hormone binding globulin in serum
timeFrame: At 1, 3, 6, 9 or 12 months
measure: Discontinuation rate
timeFrame: 12 months treatment period
Other outcomes:
Locations:
city: St. Pölten
country: Austria
state: Niederösterreich
city: Bregenz
country: Austria
city: Voitsberg
country: Austria
city: Wien
country: Austria
city: Zeltweg
country: Austria
city: Antwerpen
country: Belgium
city: Bruxelles - Brussel
country: Belgium
city: Bruxelles - Brussel
country: Belgium
city: Charleroi
country: Belgium
city: Leuven
country: Belgium
city: København NV
country: Denmark
city: København S
country: Denmark
city: Århus C
country: Denmark
city: Helsinki
country: Finland
city: Helsinki
country: Finland
city: Kuopio
country: Finland
city: Oulu
country: Finland
city: Oulu
country: Finland
city: Erlangen
country: Germany
state: Bayern
city: Geseke
country: Germany
state: Nordrhein-Westfalen
city: Köln
country: Germany
state: Nordrhein-Westfalen
city: Blankenburg
country: Germany
state: Sachsen-Anhalt
city: Dippoldiswalde
country: Germany
state: Sachsen
city: Dresden
country: Germany
state: Sachsen
city: Leipzig
country: Germany
state: Sachsen
city: Leipzig
country: Germany
state: Sachsen
city: Hamburg
country: Germany
city: Hamburg
country: Germany
city: Alkmaar
country: Netherlands
city: Almere
country: Netherlands
city: Den Helder
country: Netherlands
city: Enschede
country: Netherlands
city: Heerlen
country: Netherlands
city: Nieuwegein
country: Netherlands
city: Tilburg
country: Netherlands
city: Fornebu
country: Norway
city: Sellebakk
country: Norway
city: Göteborg
country: Sweden
city: Stockholm
country: Sweden
city: Stockholm
country: Sweden
city: Uppsala
country: Sweden
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.