check_circleStudy Completed

Contraception

Bayer Identifier:
14371
ClinicalTrials.gov Identifier:
NCT01434160
EudraCT Number:
2011-002065-37
EU CT Number:
Not Available
LCS12 adolescent study

Trial purpose

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.

Key Participants Requirements

Sex

Female

Age

12 - 17 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
304
Trial Dates
September 2011 - May 2015
Phase
Phase 3
Could I Receive a placebo
No
Products
Skyla (Levonorgestrel, BAY86-5028)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Dr. Philip LoquetAntwerpen, 2018, Belgium
Completed
UZ Leuven GasthuisbergLEUVEN, 3000, Belgium
Completed
Grand Hôpital de CharleroiCHARLEROI, 6000, Belgium
Completed
Väestöliitto, Seksuaaliterveysklinikka, HelsinkiHelsinki, 00100, Finland
Completed
Lääkäriasema Cantti OyKuopio, 70110, Finland
Completed
Kätilöopiston sairaalaHelsinki, 00610, Finland
Completed
Väestöliitto, OuluOulu, 90220, Finland
Completed
Terveystalo OuluOulu, 90100, Finland
Completed
Karolinska Universitetssjukhuset i SolnaStockholm, 171 76, Sweden
Completed
Södersjukhuset ABStockholm, 118 83, Sweden
Completed
Akademiska SjukhusetUppsala, 75185, Sweden
Terminated
Aleris SpecialistvårdGöteborg, 411 18, Sweden
Completed
UZ BrusselBRUXELLES - BRUSSEL, 1090, Belgium
Completed
DIN DOKTOR Maitii ØsterbergSellebakk, 1653, Norway
Terminated
DIN DOKTOR FORNEBUFornebu, 1364, Norway
Completed
CHU Brugmann/UVC BrugmannBRUXELLES - BRUSSEL, 1020, Belgium
Completed
Gemini ZiekenhuisDen Helder, 1780 AT, Netherlands
Completed
FlevoziekenhuisAlmere, Netherlands
Completed
St. Antonius ZiekenhuisNieuwegein, 3435 CM, Netherlands
Completed
St. Elisabeth ZiekenhuisTilburg, Netherlands
Completed
Gynaecologisch Centrum Dermout & AlbicherALKMAAR, 1817 MS, Netherlands
Completed
Atrium Medisch Centrum ParkstadHeerlen, Netherlands
Completed
Medisch Spectrum Twente, Locatie ArienspleinEnschede, Netherlands
Completed
Sex & Samfunds Præventions- & RådgivningsklinikKøbenhavn S, 2300, Denmark
Completed
Speciallæge Anette PeenÅrhus C, DK-8000, Denmark
Completed
Speciallæge Claus ChristoffersenKøbenhavn NV, DK-2400, Denmark
Completed
Ordination Dr. Schmidl-AmannSt. Pölten, 3100, Austria
Terminated
Evangelisches Krankenhaus Köln Weyertal gGmbHKöln, 50931, Germany
Completed
Praxis Hr. Dr. K. BuehlingHamburg, 22587, Germany
Completed
Praxis Fr. C. BurgkhardtLeipzig, 04299, Germany
Completed
Frauenarztpraxis Dr. Robert HantschelDippoldiswalde, 01744, Germany
Completed
Frauenarztpraxis Dr. Bernd PittnerLeipzig, 04207, Germany
Completed
Praxis Hr. Dr. D. RautenbergHamburg, 21073, Germany
Terminated
Universitätsklinikum ErlangenErlangen, 91054, Germany
Completed
Praxis Hr. E. Goeckeler-LeopoldGeseke, 59590, Germany
Completed
Frauenarztpraxis Dr. WetzelBlankenburg, 38889, Germany
Terminated
Praxis Hr. Dr. U. KoppraschDresden, 01169, Germany
Completed
Dr. Brigitte WiesenthalWien, 1070, Austria
Completed
Dr. Walter PaulikZeltweg, 8740, Austria
Completed
Ordination Dr. TrostVoitsberg, 8570, Austria
Completed
Ordination Prim. Dr. ConcinBregenz, 6900, Austria

Primary Outcome

  • Number of adverse events reported by study subjects
    date_rangeTime Frame:
    12 months treatment period
    enhanced_encryption
    Safety Issue:
    Yes
  • Portion of subjects reporting adverse events
    date_rangeTime Frame:
    12 months treatment period
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Overall satisfaction rating from 1 to 5 (from very satisfied to very dissatisfied)
    date_rangeTime Frame:
    12 months treatment period
    enhanced_encryption
    Safety Issue:
    No
  • Pearl index
    date_rangeTime Frame:
    12 months treatment period
    enhanced_encryption
    Safety Issue:
    No
  • Bleeding patterns collected from patients' diary
    date_rangeTime Frame:
    12 months treatment period
    enhanced_encryption
    Safety Issue:
    No
  • Concentration of Levonorgestrel in serum
    date_rangeTime Frame:
    At 1, 3, 6, 9 or 12 months
    enhanced_encryption
    Safety Issue:
    No
  • Concentration of sex hormone binding globulin in serum
    date_rangeTime Frame:
    At 1, 3, 6, 9 or 12 months
    enhanced_encryption
    Safety Issue:
    No
  • Discontinuation rate
    date_rangeTime Frame:
    12 months treatment period
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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