New FDA approved latex-free contraceptive device: FemCap

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.

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