FHI 360 has commenced a pivotal Phase I clinical trial in the Dominican Republic for Casea S, a novel biodegradable contraceptive implant, marking the first trial of its kind in over two decades. Aimed at offering a long-term contraception solution, Casea S is engineered to release the synthetic hormone etonogestrel, commonly used in other contraceptive implants, to prevent pregnancy for a duration of 18 to 24 months before naturally dissolving in the body. This feature is anticipated to eliminate the necessity for medical removal, addressing a significant barrier in contraceptive care access globally.

Scheduled to be conducted at the Biomedical Research Unit of Profamilia in Santo Domingo, the trial seeks to enroll approximately 30 women aged between 18 to 45. Researchers will assess the etonogestrel levels in participants’ blood, alongside the implant’s removability, safety, and tolerability post-insertion in the upper portion of the nondominant arm.

“No one form of contraception will work for everyone, everywhere, at every stage of life,” says Dr. Kavita Nanda, a director of medical research at FHI 360 and principal investigator of the Casea S study. “Improving contraceptive access requires diversifying the variety of available methods. We believe that Casea S can offer a new and exciting contraceptive option and fill a gap in the contraceptive method mix.”

Contraceptive implants that are currently available are highly effective, safe and increasingly popular. But after three to five years, they must be removed, a process requiring trained providers and medical resources. Access to these procedures may be challenging, particularly in low- and middle-income countries — where strained infrastructure, limited supplies, long distances to providers, and prolonged wait times for appointments can create barriers — and in any setting where people face obstacles to care.

“A biodegradable implant, such as Casea S, can boost access and convenience by reducing the need for repeat visits to health facilities and simultaneously lessen costs and other burdens to individuals and health care systems alike,” says Nanda.

Globally, an estimated 218 million women of reproductive age in low- and middle-income countries are interested in avoiding pregnancy but are not using effective contraceptive methods due to various barriers. Casea S represents a potential breakthrough in making contraception more accessible and acceptable across diverse settings.

The development of Casea S, in collaboration with pH Sciences and GeSea Biosciences, was partially facilitated by FHI 360’s Contraceptive Technology Innovation Initiative. The project received significant financial support from the Bill & Melinda Gates Foundation.

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