Safety and tolerability of the new contraceptive sponge Protectaid.
OBJECTIVE
This study was undertaken to assess the efficacy, safety and acceptability of two different-dose regimens of the Protectaid contraceptive sponge.


METHODS
The toxic effects of two forms of the new vaginal contraceptive sponge, Protectaid, in the cervical and vaginal tissues were studied. Both types were impregnated with F-5 gel containing different doses of nonoxynol-9 (NX9; 0.5% and 0.125%). The sponge was used by 35 women aged 20-35 years (mean 28.7 years) randomly allocated into two groups (Group A: 0.5% NX9, n = 20; Group B: 0.125% NX9, n = 15).


RESULTS
During a 12-month period both regimens demonstrated a 91.4% overall contraceptive efficacy. Colposcopic examinations showed no significant cervical or vaginal lesions in either group, except for two cases at the 2-week and 3-month examinations in Group A women. In the former, inflammatory changes of little clinical significance were seen and the colposcopic appearance of the vagina was non-specific. In this case, the focal lesions were accompanied by dilated capillaries (hyperemia). In the second case, degenerative inflammatory changes, with the inflammatory foci varying in shape and distribution, were observed. Cervical cultures taken 6 months after the start of treatment showed the presence of Mycoplasma hominis and Candida albicans in one and two cases, respectively, in Group A. In Group B, cervical cultures taken at 3 months showed Gardnerella vaginalis and beta-hemolytic streptococci group B in one and two cases, respectively.


CONCLUSIONS
The potent spermicidal and protective properties of this new contraceptive sponge may be of benefit to the sexually active female. Since the sponge was very well accepted by both the study participants and their sexual partners, it can be considered as a valuable barrier method.
Creatsas
G
G
2nd Department of Obstetrics and Gynecology, University of Athens, Aretaieio Hospital, Athens, Greece.
Elsheikh
A
A
Colin
P
P
D000282:Administration, Intravaginal; D000328:Adult; D001548:Benzalkonium Compounds / Q000009:adverse effects*; D003127:Colposcopy; D003267:Contraception / Q000379:methods; D003271:Contraceptive Agents, Female / Q000009:adverse effects*; D003274:Contraceptive Devices, Female / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D017137:Nonoxynol / Q000009:adverse effects* / Q000494:pharmacology; D020358:Sodium Cholate / Q000009:adverse effects*; D013089:Spermatocidal Agents / Q000009:adverse effects* / Q000494:pharmacology; D011795:Surveys and Questionnaires; D013997:Time Factors
D001548:Benzalkonium Compounds; D003271:Contraceptive Agents, Female; C453301:Protectaid; D013089:Spermatocidal Agents; D017137:Nonoxynol; D020358:Sodium Cholate