LCS12 Adolescent Study

Contraception Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01434160
• Other study ID #: 14371
• Secondary ID: 2011-002065-37
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2011
• Last updated: July 24, 2015
• Start date: September 2011
• Est. completion date: May 2015

Study information

• Verified date: July 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsDenmark: Danish Medicines AgencyFinland: Finnish Medicines AgencyNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Norway: Norwegian Medicines AgencySweden: Medical Products AgencyAustria: Federal Office for Safety in Health CareGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: May 2015
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 17 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Contraception

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events reported by study subjects		12 months treatment period	Yes
Primary	Portion of subjects reporting adverse events		12 months treatment period	Yes
Secondary	Overall satisfaction rating from 1 to 5 (from very satisfied to very dissatisfied)		12 months treatment period	No
Secondary	Pearl index		12 months treatment period	No
Secondary	Bleeding patterns collected from patients' diary		12 months treatment period	No
Secondary	Concentration of Levonorgestrel in serum		At 1, 3, 6, 9 or 12 months	No
Secondary	Concentration of sex hormone binding globulin in serum		At 1, 3, 6, 9 or 12 months	No
Secondary	Discontinuation rate		12 months treatment period	No

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