A clinical trial of Neo Sampoon vaginal tablets and Emko foam in Alexandria, Egypt.
Results are reported for a comparative 12-month study of Neo Sampoon foaming vaginal tablets containing 60 mg of the spermicide, menfegol, and Emko vaginal foam containing an 8.0% concentration of the spermicide, nonoxynol-9. Conducted in cooperation with the Family Planning Association in Alexandria, Egypt, the trial included 349 women who were randomly allocated to use one of the two contraceptive products. The twelve-month cumulative life-table rate for accidental pregnancy (per 100 women) was 2.8 for Neo Sampoon tablet users and 2.1 for Emko foam users. The 12-month continuation rates were 77.6 and 77.2 per 100 women for the tablet and foam groups, respectively. In both groups, the majority of discontinuations from the study were for personal reasons, including lack of confidence in the method, messiness, partner's objection and a burning sensation. Few women reported a product-related complaint while using their assigned contraceptive method. The most commonly reported complaint for both methods was that use of the product led to an uncomfortable burning sensation for the woman and/or her partner. This complaint, however, was cited by less than 5% of the women in each group. Thus, a combination of low pregnancy rates, few complications and complaints and high continuation rates confirm the relative acceptability, effectiveness and short-term safety of these methods of contraception among this sample of Egyptian women.
Youssef
H
H
Crofton
V A
VA
Smith
S C
SC
Siemens
A J
AJ
D000282:Administration, Intravaginal; D000328:Adult; D001558:Benzethonium / Q000008:administration & dosage* / Q000009:adverse effects; D002986:Clinical Trials as Topic; D003271:Contraceptive Agents, Female / Q000008:administration & dosage* / Q000009:adverse effects; D004338:Drug Combinations / Q000008:administration & dosage / Q000009:adverse effects; D004534:Egypt; D005193:Family Planning Services; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects; D011247:Pregnancy; D000644:Quaternary Ammonium Compounds / Q000008:administration & dosage*; D011897:Random Allocation; D014622:Vaginal Creams, Foams, and Jellies
D003271:Contraceptive Agents, Female; D004338:Drug Combinations; C002813:Emko vaginal foam; D000644:Quaternary Ammonium Compounds; D014622:Vaginal Creams, Foams, and Jellies; D001558:Benzethonium; D011092:Polyethylene Glycols; C029270:menfegol