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

Bayer HealthCare AG0 sites360 target enrollmentAugust 8, 2011

Overview

No summary available.

Registry

who.int

Start Date

August 8, 2011

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

•1\. The subject has signed and dated the informed consent form or given assent.
•2\. The subject is a female adolescent, age 12 to under 18 years of age at the Screening visit, is generally healthy, post\-menarcheal, nulliparous or parous, and requires contraception.
•3\. 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\-10 cm).
•5\. The subject has clinically normal safety laboratory results inside the specified range for inclusion.
•6\. 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). A cervical smear must be taken at the Screening Visit or a documented normal result must have been obtained not more than 6 months before the Screening Visit. Subjects with atypical squamous cells of undetermined significance (ASCUS) can be included in the study if they have a Human Papilloma Virus (HPV) DNA test that, according to the standards of the central laboratory, is negative for high\-risk HPV.
•7\. The subject is willing and able to attend the scheduled study visits and to comply with
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 360
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range

•1\. Known or suspected pregnancy or is lactating.
•2\. Vaginal delivery, cesarean delivery, or abortion less than 6 weeks before Visit 1\. Note: Postpartum insertions should be postponed until uterus is fully involuted, however not earlier than 6 weeks after delivery. If involution is substantially delayed,
•consider waiting until 12 weeks postpartum. In the event of a difficult insertion and/or exceptional pain or bleeding during or after insertion, physical examination and ultrasound should be performed immediately to exclude perforation.
•3\. History of ectopic pregnancies.
•4\. Infected abortion or postpartum endometritis less 3 months before Visit 1\.
•5\. Abnormal uterine bleeding of unknown origin.
•6\. Any lower genital tract infection (until successfully treated).
•7\. Acute or history of recurrent pelvic inflammatory disease.
•8\. Congenital or acquired uterine anomaly.
•9\. Submucous uterine fibroids