LCS12 Adolescent Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01434160
First received: September 13, 2011
Last updated: August 28, 2014
Last verified: August 2014
  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.


Condition Intervention Phase
Contraception
Drug: LCS (Levonorgestrel IUS, BAY86-5028)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Number of adverse events reported by study subjects [ Time Frame: 12 months treatment period ] [ Designated as safety issue: Yes ]
  • Portion of subjects reporting adverse events [ Time Frame: 12 months treatment period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall satisfaction rating from 1 to 5 (from very satisfied to very dissatisfied) [ Time Frame: 12 months treatment period ] [ Designated as safety issue: No ]
  • Pearl index [ Time Frame: 12 months treatment period ] [ Designated as safety issue: No ]
  • Bleeding patterns collected from patients' diary [ Time Frame: 12 months treatment period ] [ Designated as safety issue: No ]
  • Concentration of Levonorgestrel in serum [ Time Frame: At 1, 3, 6, 9 or 12 months ] [ Designated as safety issue: No ]
  • Concentration of sex hormone binding globulin in serum [ Time Frame: At 1, 3, 6, 9 or 12 months ] [ Designated as safety issue: No ]
  • Discontinuation rate [ Time Frame: 12 months treatment period ] [ Designated as safety issue: No ]

Enrollment: 304
Study Start Date: September 2011
Estimated Study Completion Date: June 2015
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: LCS (Levonorgestrel IUS, 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.

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01434160

  Hide Study Locations
Locations
Austria
St. Pölten, Niederösterreich, Austria, 3100
Bregenz, Austria, 6900
Voitsberg, Austria, 8570
Wien, Austria, 1070
Zeltweg, Austria, 8740
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 V, Denmark, 1632
Århus C, Denmark, DK-8000
Finland
Helsinki, Finland, 00100
Helsinki, Finland, 00610
Kuopio, Finland, 70110
Oulu, Finland, 90220
Oulu, Finland, 90100
Germany
Erlangen, Bayern, Germany, 91054
Geseke, Nordrhein-Westfalen, Germany, 59590
Köln, Nordrhein-Westfalen, Germany, 50931
Blankenburg, Sachsen-Anhalt, Germany, 38889
Dippoldiswalde, Sachsen, Germany, 01744
Dresden, Sachsen, Germany, 01169
Leipzig, Sachsen, Germany, 04299
Leipzig, Sachsen, Germany, 04207
Hamburg, Germany, 22587
Hamburg, Germany, 21073
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
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01434160     History of Changes
Other Study ID Numbers: 14371, 2011-002065-37
Study First Received: September 13, 2011
Last Updated: August 28, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Norway: Norwegian Medicines Agency
Sweden: Medical Products Agency
Austria: Federal Office for Safety in Health Care
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Intrauterine
contraception
adolescent

Additional relevant MeSH terms:
Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on September 18, 2014