New FDA approved latex-free contraceptive device: FemCap

A. Shihata

Scrippes Institution of Science and Medicine, California, USA

Objectives: A) To develop a woman-controlled barrier contraceptive. B) Easy to use and latex-free. C) To deliver spermicide or any future Microbicide on the vaginal side of the FemCap.

Materials and Methods: The FemCap is made of non-allergenic material and is designed to cover the cervix completely–the site of co-receptors for the HIV virus (CCR-5 and CXCR-4) and the portal of entry for sperm, bacteria and viruses-mechanically and chemically. The FemCap is designed with a unique groove facing the vaginal opening to store and deliver spermicide or any Microbicide. The FemCap comes in three sizes that fits almost every woman, without the laborious fitting and measurement.

Results: Safety: None of the participants had any significant side effects and the risk of UTI was found to be significantly less than the diaphragm users. Effectiveness: The first- generation FemCap was successful in preventing pregnancy in 86.5% of the participants in the typical use during the six-month clinical trial. One pregnancy occurred among the 85 women who completed eight weeks to test the second-generation FemCap. Acceptability: 75% of women who had prior experience with the diaphragm preferred the FemCap.

Conclusion: The FemCap’s unique groove traps the invading sperm, bacteria, and viruses as soon as they are deposited into the vagina and expose them to spermicide or Microbicide. The videotape provided with the FemCap enforces learning and saves on the clinician time

The FemCap clinical trial were funded by (USAID), sponsored by (CONRAD), and monitored and analyzed by (FHI). We acknowledge the genourous support received.