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

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 - LCS12 adolescent study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40073

Enrollment

Registered

2011-07-28

Start date

2011-09-26

Completion date

Unknown

Last updated

2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intrauterine anticonceptie intrauterine system as a contraceptive prevention of pregnancy

Interventions

LCS12 insertion into the uterus at insertion visit 2 with the study treatment of 12 months. An optional follow up phase up to 2 years will be offered for all subjects completing 12 month treatment t

Eligibility

Age

12 Years to 17 Years

Inclusion criteria

Inclusion criteria: - The subject has signed and dated the informed consent form. - The subject is a female adolescent, generally healthy, post-menarcheal, nulliparous or parous requiring contraception and is under 18 years of age at 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 LCS12 (uterine sound depth 6-10cm). - The subject 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

Exclusion criteria: - Known or suspected pregnancy or is lactating. - Vaginal delivery, cesarean delivery, or abortion less than 6 weeks before Visit 1. - Historic 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.

Design outcomes

Primary

Measure	Time frame
1) Number of adverse events reported by study subjects 2) Portion of subjects reporting adverse events	—

Secondary

Measure	Time frame
1) Overall satisfaction rating from 1 to 5 (from very satisfied to very dissatisfied) 2) Pearl Index 3) Bleeding patterns collected from patients' diary 4) Concentration of levonorgestrel in serum 5) Concentration of sex hormone binding globulin in serum 6) Discontinuation rate	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)