FemCap – the Earliest Version
The earliest version of FemCap was clinically tested in 1988; the preliminary clinical trial was published in 1991 and co-authored by James Trussell, Ph.D of Princeton University.
The pivotal clinical trials were also conducted with this earlier version of FemCap in ten universities in United States from 1995-1997.
Based on this study the FDA approved this earlier version of 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 FemCap was proven to be safe and effective in the pivotal clinical trials, we learned that this first-generation device had two drawbacks:
- Poor effectiveness rate of the large (30 mm) FemCap designed for women who delivered vaginally due to frequent dislodgement.
- Difficulty with removal of FemCap.
Click link below to learn about improvement:
To compensate for the poor vaginal tone in women who delivered vaginally, FemCap Inc. increased the dimensions of the brim (see arrows on image) on the large FemCap. This increased the surface area of contact between the brim and the vagina. The new dimensions also increased stability and minimized dislodgment, thus enhancing effectiveness of FemCap in women who delivered vaginally.
To remediate the second drawback we added a strap over the dome of 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 FemCap the FDA:
- Strongly advised women to insert FemCap prior to sexual arousal, every time to ensure correct placement over the cervix.
- Recommended that women may use a backup method during the learning phase of FemCap.
- To use Emergency contraception as a backup method if needed, in case the woman has not used 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. FemCap has not been withdrawn from any market for any reason.