This clinical trial is focused on the prevention of pregnancy using a treatment called the Levonorgestrel Vaginal Delivery System 75, also known by its code name CH211-75. The study aims to evaluate how effective, safe, and tolerable this system is as a contraceptive method over the course of 13 menstrual cycles. The Levonorgestrel Vaginal Delivery System is a device designed for vaginal use that releases a hormone called levonorgestrel, which is commonly used in various forms of birth control.
Participants in the study will use the Levonorgestrel Vaginal Delivery System for thirteen 28-day cycles. Throughout the study, researchers will monitor the participants to assess the system’s ability to prevent pregnancy and to observe any side effects or changes in health. The study will also look at how the system affects the quality of life and satisfaction of the participants. Additionally, for younger participants, the study will explore any changes in bone health using a method called DXA, which is a type of scan that measures bone density.
The purpose of this study is to demonstrate the contraceptive efficacy of the Levonorgestrel Vaginal Delivery System. Participants will be observed for any adverse events, changes in vital signs, and other health indicators to ensure the safety and tolerability of the treatment. The study will provide valuable information on how well this contraceptive method works and its impact on users’ health and well-being.



Czechia
Germany
Hungary
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Poland
Romania
Slovakia
Spain