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.
