LCS12 Adolescent Study

July 24, 2015 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

304

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Bregenz, Austria, 6900
      • Voitsberg, Austria, 8570
      • Wien, Austria, 1070
      • Zeltweg, Austria, 8740
    • Niederösterreich
      • St. Pölten, Niederösterreich, Austria, 3100
  • Belgium
      • Antwerpen, Belgium, 2018
      • Bruxelles - Brussel, Belgium, 1020
      • Bruxelles - Brussel, Belgium, 1090
      • Charleroi, Belgium, 6000
      • Leuven, Belgium, 3000
  • Denmark
      • København NV, Denmark, DK-2400
      • København S, Denmark, 2300
      • Århus C, Denmark, DK-8000
  • Finland
      • Helsinki, Finland, 00100
      • Helsinki, Finland, 00610
      • Kuopio, Finland, 70110
      • Oulu, Finland, 90100
      • Oulu, Finland, 90220
  • Germany
      • Hamburg, Germany, 21073
      • Hamburg, Germany, 22587
    • Bayern
      • Erlangen, Bayern, Germany, 91054
    • Nordrhein-Westfalen
      • Geseke, Nordrhein-Westfalen, Germany, 59590
      • Köln, Nordrhein-Westfalen, Germany, 50931
    • Sachsen
      • Dippoldiswalde, Sachsen, Germany, 01744
      • Dresden, Sachsen, Germany, 01169
      • Leipzig, Sachsen, Germany, 04207
      • Leipzig, Sachsen, Germany, 04299
    • Sachsen-Anhalt
      • Blankenburg, Sachsen-Anhalt, Germany, 38889
  • Netherlands
      • Alkmaar, Netherlands, 1817 MS
      • Almere, Netherlands
      • Den Helder, Netherlands, 1780 AT
      • Enschede, Netherlands
      • Heerlen, Netherlands
      • Nieuwegein, Netherlands, 3435 CM
      • Tilburg, Netherlands
  • Norway
      • Fornebu, Norway, 1364
      • Sellebakk, Norway, 1653
  • Sweden
      • Göteborg, Sweden, 411 18
      • Stockholm, Sweden, 171 76
      • Stockholm, Sweden, 118 83
      • Uppsala, Sweden, 75185

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: Skyla (Levonorgestrel, BAY86-5028)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of adverse events reported by study subjects
Time Frame: 12 months treatment period
12 months treatment period
Portion of subjects reporting adverse events
Time Frame: 12 months treatment period
12 months treatment period

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall satisfaction rating from 1 to 5 (from very satisfied to very dissatisfied)
Time Frame: 12 months treatment period
12 months treatment period
Pearl index
Time Frame: 12 months treatment period
12 months treatment period
Bleeding patterns collected from patients' diary
Time Frame: 12 months treatment period
12 months treatment period
Concentration of Levonorgestrel in serum
Time Frame: At 1, 3, 6, 9 or 12 months
At 1, 3, 6, 9 or 12 months
Concentration of sex hormone binding globulin in serum
Time Frame: At 1, 3, 6, 9 or 12 months
At 1, 3, 6, 9 or 12 months
Discontinuation rate
Time Frame: 12 months treatment period
12 months treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

September 13, 2011

First Submitted That Met QC Criteria

September 13, 2011

First Posted (Estimate)

September 14, 2011

Study Record Updates

Last Update Posted (Estimate)

July 27, 2015

Last Update Submitted That Met QC Criteria

July 24, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14371
  • 2011-002065-37 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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