Trial Condition(s):

Contraception

LCS12 adolescent study

Bayer Identifier:

14371

ClinicalTrials.gov Identifier:

NCT01434160

EudraCT Number:

2011-002065-37

EU CT Number:

Not Available

Study Completed

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.

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

Trial Summary

Enrollment Goal
304
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Skyla (Levonorgestrel, BAY86-5028)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Dr. Philip Loquet

Antwerpen, Belgium, 2018

Status
Completed
Locations

UZ Leuven Gasthuisberg

LEUVEN, Belgium, 3000

Status
Completed
Locations

Grand Hôpital de Charleroi

CHARLEROI, Belgium, 6000

Status
Completed
Locations

Väestöliitto, Seksuaaliterveysklinikka, Helsinki

Helsinki, Finland, 00100

Status
Completed
Locations

Lääkäriasema Cantti Oy

Kuopio, Finland, 70110

Status
Completed
Locations

Kätilöopiston sairaala

Helsinki, Finland, 00610

Status
Completed
Locations

Väestöliitto, Oulu

Oulu, Finland, 90220

Status
Completed
Locations

Terveystalo Oulu

Oulu, Finland, 90100

Status
Completed
Locations

Karolinska Universitetssjukhuset i Solna

Stockholm, Sweden, 171 76

Status
Completed
Locations

Södersjukhuset AB

Stockholm, Sweden, 118 83

Status
Completed
Locations

Akademiska Sjukhuset

Uppsala, Sweden, 75185

Status
Completed
Locations

Aleris Specialistvård

Göteborg, Sweden, 411 18

Status
Terminated
Locations

UZ Brussel

BRUXELLES - BRUSSEL, Belgium, 1090

Status
Completed
Locations

DIN DOKTOR Maitii Østerberg

Sellebakk, Norway, 1653

Status
Completed
Locations

DIN DOKTOR FORNEBU

Fornebu, Norway, 1364

Status
Terminated
Locations

CHU Brugmann/UVC Brugmann

BRUXELLES - BRUSSEL, Belgium, 1020

Status
Completed
Locations

Gemini Ziekenhuis

Den Helder, Netherlands, 1780 AT

Status
Completed
Locations

Flevoziekenhuis

Almere, Netherlands

Status
Completed
Locations

St. Antonius Ziekenhuis

Nieuwegein, Netherlands, 3435 CM

Status
Completed
Locations

St. Elisabeth Ziekenhuis

Tilburg, Netherlands

Status
Completed
Locations

Gynaecologisch Centrum Dermout & Albicher

ALKMAAR, Netherlands, 1817 MS

Status
Completed
Locations

Atrium Medisch Centrum Parkstad

Heerlen, Netherlands

Status
Completed
Locations

Medisch Spectrum Twente, Locatie Ariensplein

Enschede, Netherlands

Status
Completed
Locations

Sex & Samfunds Præventions- & Rådgivningsklinik

København S, Denmark, 2300

Status
Completed
Locations

Speciallæge Anette Peen

Århus C, Denmark, DK-8000

Status
Completed
Locations

Speciallæge Claus Christoffersen

København NV, Denmark, DK-2400

Status
Completed
Locations

Ordination Dr. Schmidl-Amann

St. Pölten, Austria, 3100

Status
Completed
Locations

Evangelisches Krankenhaus Köln Weyertal gGmbH

Köln, Germany, 50931

Status
Terminated
Locations

Praxis Hr. Dr. K. Buehling

Hamburg, Germany, 22587

Status
Completed
Locations

Praxis Fr. C. Burgkhardt

Leipzig, Germany, 04299

Status
Completed
Locations

Frauenarztpraxis Dr. Robert Hantschel

Dippoldiswalde, Germany, 01744

Status
Completed
Locations

Frauenarztpraxis Dr. Bernd Pittner

Leipzig, Germany, 04207

Status
Completed
Locations

Praxis Hr. Dr. D. Rautenberg

Hamburg, Germany, 21073

Status
Completed
Locations

Universitätsklinikum Erlangen

Erlangen, Germany, 91054

Status
Terminated
Locations

Praxis Hr. E. Goeckeler-Leopold

Geseke, Germany, 59590

Status
Completed
Locations

Frauenarztpraxis Dr. Wetzel

Blankenburg, Germany, 38889

Status
Completed
Locations

Praxis Hr. Dr. U. Kopprasch

Dresden, Germany, 01169

Status
Terminated
Locations

Dr. Brigitte Wiesenthal

Wien, Austria, 1070

Status
Completed
Locations

Dr. Walter Paulik

Zeltweg, Austria, 8740

Status
Completed
Locations

Ordination Dr. Trost

Voitsberg, Austria, 8570

Status
Completed
Locations

Ordination Prim. Dr. Concin

Bregenz, Austria, 6900

Status
Completed

Trial Design