Clinical Research Directory

Efficacy, Safety, and Tolerability of Levonorgestrel Vaginal System

Sponsor: Chemo Research

Summary

The goal of this clinical trial is to learn if drug levonorgestrel vaginal ring works as a contraceptive adult and adolescent females who are able to conceive (i.e. get pregnant). It will also learn about the safety and tolerability of levonorgestrel vaginal ring. The main questions it aims to answer are: Does drug levonorgestrel vaginal ring lower the number of pregnancies with continued use? What adverse effects do participants experience by using levonorestrel vaginal ring? Researchers will count the number of pregnancies with levonorgestrel vaginal ring after a participant uses it for a year to see if the number of pregnancies is low (i.e. women and girls do not get pregnant). Participants will: Use levonorgestrel vaginal ring for 28 days (called one cycle); for a total of 14 cycles (which is a little more than year) Visit the clinic about 8 to 10 times over about 14 months for checkups and tests with an additional approximately 13 phone calls Keep a diary of their pregnancies and number of times they use additional contraceptive (e.g. condoms)

Official title: Prospective, Multicenter, Open-label and Non-randomized Trial on Contraceptive Efficacy, Safety and Tolerability of LVS (Levonorgestrel Vaginal System) During 13 Cycles

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