Intravaginal contraceptive sponge impregnated with nonoxynol-9. the development of sponge for clinical efficacy trials
Takano, R.
Nihon Funin Gakkai Zasshi 25(4): 80-87
1980
ISSN/ISBN: 0029-0629 PMID: 12158575 Document Number: 460280
Newly designed intravaginal polyurethane sponges containing the spermicide nonoxynol-9 were developed for contraceptive purposes. The sponges were made by the polymerization of urethane monomers in a solution of nonoxynol-9. This new biomaterial is analogous to a large, thick cervical cup with a dimple in the center for ease of insertion and positioning to the cervix (and external os). There is no need for precoital planning or preparation for usage of this sponge. The release of the spermicidal agent from the sponges was 1st determined by soaking the sponges in saline and squeezing the nonoxynol-9 solution from them. In order to determine the actual amount of nonoxynol-9 released from the sponge, 2 analytic techniques were used. 1 method was ultraviolet spectoscopy and its accuracy ranged from 85-97%. The other was bioassay for the spermicidal activity and its accuracy ranged from 100-124%. To simulate the actual wearing of the sponge by a patient, the sponges were soaked in a large volume of saline and almost 50% of the spermicidal agent was released during the first 24 hours. In conjunction with the laboratory studies, a limited study to determine acceptability of the devices was investigated in normal women. The women were asked to wear the sponges for 1, 2, 3, 4, 5, 6, and 7 consecutive days. It was found that all women in the population could not tolerate the sponge longer than 5 days due to the odor. Thus, with the good release rates for 2-4 days and patient acceptability for 2 days of wear, a protocol for the use of the intravaginal sponge as a 2-day device was established. (author's)