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

Bayer0 个研究点目标入组 96 人开始时间: 待定最近更新: 2024年6月24日

适应症

试验速览

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•- 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

•- 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.

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