LCS12 Adolescent Study

NCT ID: NCT01434160

Last Updated: 2015-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 304 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2015-05-31

Brief Summary

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.

Conditions

Contraception

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

Skyla (Levonorgestrel, BAY86-5028)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Sankt Pölten, Lower Austria, Austria

Bregenz, , Austria

Vienna, , Austria

Voitsberg, , Austria

Zeltweg, , Austria

Antwerp, , Belgium

Bruxelles - Brussel, , Belgium

Bruxelles - Brussel, , Belgium

Charleroi, , Belgium

Leuven, , Belgium

Århus C, , Denmark

København NV, , Denmark

København S, , Denmark

Helsinki, , Finland

Helsinki, , Finland

Kuopio, , Finland

Oulu, , Finland

Oulu, , Finland

Erlangen, Bavaria, Germany

Hamburg, City state of Hamburg, Germany

Hamburg, City state of Hamburg, Germany

Cologne, North Rhine-Westphalia, Germany

Geseke, North Rhine-Westphalia, Germany

Dippoldiswalde, Saxony, Germany

Dresden, Saxony, Germany

Leipzig, Saxony, Germany

Leipzig, Saxony, Germany

Blankenburg, Saxony-Anhalt, Germany

Alkmaar, , Netherlands

Almere Stad, , Netherlands

Den Helder, , Netherlands

Enschede, , Netherlands

Heerlen, , Netherlands

Nieuwegein, , Netherlands

Tilburg, , Netherlands

Fornebu, , Norway

Sellebakk, , Norway

Gothenburg, , Sweden

Stockholm, , Sweden

Stockholm, , Sweden

Uppsala, , Sweden

Countries

Austria; Belgium; Denmark; Finland; Germany; Netherlands; Norway; Sweden

References

Gemzell-Danielsson K, Buhling KJ, Dermout SM, Lukkari-Lax E, Montegriffo E, Apter D. A Phase III, single-arm study of LNG-IUS 8, a low-dose levonorgestrel intrauterine contraceptive system (total content 13.5mg) in postmenarcheal adolescents. Contraception. 2016 Jun;93(6):507-12. doi: 10.1016/j.contraception.2016.02.004. Epub 2016 Feb 9.

Reference Type: DERIVED

PMID: 26872720 (View on PubMed)

Other Identifiers

2011-002065-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

14371

Identifier Type: -

Identifier Source: org_study_id