While woman-controlled barrier contraceptive devices are the safest, and provide a viable alternative to the condom; they are rarely used due to the lack of options. We developed the FemCap to increase choices of female-controlled contraceptives.
The earliest version of the FemCap was clinically tested in 1988; the preliminary clinical trial was published in 1991 and co-authored by James Trussell, Ph.D of
The pivotal clinical trials were also conducted with this earlier version of the FemCap in ten universities in United States from 1995-1997.
(See earlier version FemCap featured by Katie Couric of NBC Today Show in 1992).
Based on this study the FDA approved this earlier version of the FemCap to be safe and effective for use by women of childbearing age to prevent or postpone pregnancy. Despite the fact that this earlier version of the FemCap was proven to be safe and effective in the pivotal clinical trials, we have learned that this first-generation device had two drawbacks.
First, poor effectiveness rate of the large 30 mm FemCap that is designed for women who delivered vaginally due to frequent dislodgement, and Second difficulty with the removal of the FemCap.
- To compensate for the poor vaginal tone in women who delivered vaginally, FemCap Inc. increased the dimensions of the brim (pointed by the arrows) on the large 30 mm FemCap. This increased the surface area of contact between the brim and the vagina. This also increased the stability and minimized dislodgment, thus enhancing effectiveness of the FemCap in women who delivered vaginally.
- Added a strap over the dome of the FemCap to facilitate removal.
Second Generation FemCap
The second generation FemCap with the removal strap is the only device approved by the FDA for marketing.
To further enhance the effectiveness of the FemCap the FDA:
- Strongly advised women to insert the FemCap prior to sexual arousal, every time to ensure correct placement over the cervix.
- Recommended that women may use a back up method during the learning phase of the FemCap.
- To use Emergency contraception as a back-up method if needed, in case the woman has not used the FemCap or used incorrectly.
- Use the instructional video to supplement the verbal and the written instruction.
The Second generation FemCap with the removal strap is the only device approved in European countries in July 1999 and by the FDA in March 2003 for marketing. The FemCap has not withdrawn from any market for any reason.