THE CLINICAL TRIAL
The primary objective of the LevoCept Study was to assess the safety and effectiveness of a novel long-lasting and reversible intrauterine device (IUD). This contraceptive method shares similarities with the hormonal IUDs currently approved by the FDA. However, what sets it apart is its composition of a highly flexible material with a unique spring-like structure. This innovative design aims to conform to the contours of the uterus, maximizing comfort during the insertion process of the device.
The clinical trial faced a challenge due to the striking resemblance of this birth control method to FDA-approved hormonal IUDs already available in the market. Moreover, the existing devices were known to cause painful complications during the insertion procedure. Sebela Pharmaceuticals addressed this challenge by introducing their investigational IUD with a distinct design and insertion method, prioritizing patient comfort. This unique approach became the central focus of the patient recruitment campaign developed for the clinical trial.