Trial Condition(s):
Contraception
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.
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | ||
|---|---|---|---|
Locations Dr. Philip Loquet Antwerpen, Belgium, 2018 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Grand Hôpital de Charleroi CHARLEROI, Belgium, 6000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Väestöliitto, Seksuaaliterveysklinikka, Helsinki Helsinki, Finland, 00100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Lääkäriasema Cantti Oy Kuopio, Finland, 70110 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Kätilöopiston sairaala Helsinki, Finland, 00610 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Väestöliitto, Oulu Oulu, Finland, 90220 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Terveystalo Oulu Oulu, Finland, 90100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Karolinska Universitetssjukhuset i Solna Stockholm, Sweden, 171 76 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Södersjukhuset AB Stockholm, Sweden, 118 83 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Akademiska Sjukhuset Uppsala, Sweden, 75185 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Aleris Specialistvård Göteborg, Sweden, 411 18 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations UZ Brussel BRUXELLES - BRUSSEL, Belgium, 1090 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations DIN DOKTOR Maitii Østerberg Sellebakk, Norway, 1653 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations DIN DOKTOR FORNEBU Fornebu, Norway, 1364 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations CHU Brugmann/UVC Brugmann BRUXELLES - BRUSSEL, Belgium, 1020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Gemini Ziekenhuis Den Helder, Netherlands, 1780 AT | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Flevoziekenhuis Almere, Netherlands | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations St. Antonius Ziekenhuis Nieuwegein, Netherlands, 3435 CM | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations St. Elisabeth Ziekenhuis Tilburg, Netherlands | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Gynaecologisch Centrum Dermout & Albicher ALKMAAR, Netherlands, 1817 MS | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Atrium Medisch Centrum Parkstad Heerlen, Netherlands | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Medisch Spectrum Twente, Locatie Ariensplein Enschede, Netherlands | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Sex & Samfunds Præventions- & Rådgivningsklinik København S, Denmark, 2300 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Speciallæge Anette Peen Århus C, Denmark, DK-8000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Speciallæge Claus Christoffersen København NV, Denmark, DK-2400 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Ordination Dr. Schmidl-Amann St. Pölten, Austria, 3100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Evangelisches Krankenhaus Köln Weyertal gGmbH Köln, Germany, 50931 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Praxis Hr. Dr. K. Buehling Hamburg, Germany, 22587 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Praxis Fr. C. Burgkhardt Leipzig, Germany, 04299 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Frauenarztpraxis Dr. Robert Hantschel Dippoldiswalde, Germany, 01744 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Frauenarztpraxis Dr. Bernd Pittner Leipzig, Germany, 04207 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Praxis Hr. Dr. D. Rautenberg Hamburg, Germany, 21073 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Universitätsklinikum Erlangen Erlangen, Germany, 91054 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Praxis Hr. E. Goeckeler-Leopold Geseke, Germany, 59590 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Frauenarztpraxis Dr. Wetzel Blankenburg, Germany, 38889 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Praxis Hr. Dr. U. Kopprasch Dresden, Germany, 01169 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Dr. Brigitte Wiesenthal Wien, Austria, 1070 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Dr. Walter Paulik Zeltweg, Austria, 8740 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Ordination Dr. Trost Voitsberg, Austria, 8570 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Ordination Prim. Dr. Concin Bregenz, Austria, 6900 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Number of adverse events reported by study subjectsTimeframe: 12 months treatment period
- Portion of subjects reporting adverse eventsTimeframe: 12 months treatment period
Secondary Outcome
- Overall satisfaction rating from 1 to 5 (from very satisfied to very dissatisfied)Timeframe: 12 months treatment period
- Pearl indexTimeframe: 12 months treatment period
- Bleeding patterns collected from patients' diaryTimeframe: 12 months treatment period
- Concentration of Levonorgestrel in serumTimeframe: At 1, 3, 6, 9 or 12 months
- Concentration of sex hormone binding globulin in serumTimeframe: At 1, 3, 6, 9 or 12 months
- Discontinuation rateTimeframe: 12 months treatment period
Additional Information
Copyright © Bayer
Powered by
