Postcoital testing after the use of a bio-adhesive acid buffering gel (ACIDFORM) and a 2% nonoxynol-9 product.

ACIDFORM is a gel already shown to be safe in vaginal use during six consecutive days through colposcopic observation. A randomized, blinded, crossover study was carried out to compare the spermicidal effect of ACIDFORM to that of a commercial 2% nonoxynol-9 (N-9) product. Twenty sexually active, sterilized women, aged 19-45 years, with regular cycles, normal gynecological exam, no previous sexually transmitted infection (STI) and stable partner willing to undergo four postcoital tests (PCTs) at midcycle during four different menstrual cycles, were enrolled in the study. Known allergy to N-9 or ACIDFORM, oligospermic partner, chronic diseases, use of hormones, previous treatment for STI or presence of STI at screening tests were criteria for exclusion. ACIDFORM or N-9 product administered 0-30 min precoitus or ACIDFORM given 8-10 h precoitus significantly reduced the mean number of progressively motile sperm compared to control cycles (0.19, 0.07, 0.75 vs. 17.94, respectively, p<.05, Wilcoxon test). All treated cycles had five or fewer progressively motile sperm in midcycle cervical mucus, confirming in vivo the spermicidal effect of ACIDFORM previously observed in vitro and in animal models.

A multinational evaluation of the efficacy, safety and acceptability of the Protectaid contraceptive sponge.

OBJECTIVE: The Protectaid sponge (Gefar Pharma, Switzerland) is a new feminine barrier contraceptive method containing three low-dose spermicidal agents. In order to evaluate its efficacy and safety profiles, an international, multicenter study has been conducted in four countries. METHODS: Healthy, presumably fertile and sexually active women were enrolled in this study and were followed at 15 days, 3, 6, 9 and 12 months. Contraceptive efficacy was assessed by a pregnancy test, while safety was evaluated by performing gynecological examinations as well as reporting adverse events. The 'acceptability' of the sponge by the women was assessed through a standard questionnaire. RESULTS: A total of 129 women were enrolled in the study, generating 1182 cycles of use of the sponge. The overall efficacy rate was 77%, with no significant influence of age or parity. Acceptability was high, with 85% of subjects being symptom- or problem-free while using the sponge. Finally, the safety profile was very good, with no clinically significant evidence of local or systemic adverse reactions. CONCLUSION: The new Protectaid sponge is a safe and effective non-hormonal contraceptive method for women.

A new vaginal antimicrobial contraceptive formulation: phase I clinical pilot studies.

Pilot clinical trials were performed with a new vaginal suppository called "Long Acting, Sustained Release of Spermicide" ("LASRS"). No visual or colposcopic lesions or patient complaints occurred as a result of using LASRS with increasing doses of nonoxynol-9 (up to 20%) for 5 days or of applying the highest dose of nonoxynol-9 (20%; total 400 mg) for 8 h. Colposcopic or visual lesions were also not induced when LASRS with 20% nonoxynol-9 was used for 7 consecutive days by the study participants except for those who developed symptomatic monilia vaginitis. Symptoms were reported although these were mostly minor. A long-lasting, bioadhesive, translucent layer (film) of formulation formed over the vaginal and cervical surfaces. Postcoital spermicidal studies showed LASRS to be highly effective for prolonged periods of time. Although intercourse was delayed for 5 to 8.5 h after insertion of the formulation, an average of only 0. 2 motile sperm/HPF could be found in cervical mucus. These studies suggest LASRS to possess advantages over presently marketed formulations by having long-term efficacy and by forming a bioadhesive, presumably protective layer over the genital tract epithelium. The results also suggest the formulation to decrease the vaginal irritation caused by nonoxynol-9 as noted by colposcopy. These pilot data support a more extensive study with the LASRS suppository.

Acceptability of two spermicides in five countries.

Data from a large, international, multicenter, randomized trial were analyzed to compare the acceptability of two nonoxynol-9 spermicide preparations. Women who wished to use a spermicide for contraception were randomly assigned to use either a foaming tablet (n = 383) or a nonoxynol-9 film (n = 382) for 28 weeks as their only method of contraception. Participants completed questionnaires about acceptability of the assigned product 4 weeks after admission and at discontinuation. Women in both groups had very favorable opinions of the spermicide. The proportion of women who said that they liked their assigned product very much was 50% in the tablet group and 55% in the film group. Significantly more women in the film group rated the spermicide difficult to insert and stated that the product stuck to the finger during insertion. More women in the tablet group said that the product was messy and that, at least once, it did not dissolve. In both groups, liking the product was significantly associated with consistency of use, but not with subsequent pregnancy. Participants' male partners had little influence on participants' opinions about, or use of, the spermicides. Although previous analyses showed that both spermicides are associated with high pregnancy rates, they are both highly acceptable to most women.

PIP: This study compares the acceptability of two nonoxynol-9 spermicide preparations in Mexico, Ecuador, Guatemala, Ghana and the US. A total of 765 women (383 using a foaming tablet and 382 using nonoxynol-9 film for 28 weeks) were enrolled. Participants completed a questionnaire about acceptability of the assigned product, 4 weeks after admission and at discontinuation. Result of the trial revealed that women in both groups had very favorable opinions of the spermicide. The proportion of women who said that they liked their assigned product very much was 50% in the tablet group and 55% in the film group. Significantly more women in the film group rated the spermicide difficult to insert and stated that the product stuck to the finger during insertion. More women in the tablet group expressed that the product was messy and that, at least once, it did not dissolve. In both groups, liking the product was significantly associated with consistency of use, but not with subsequent pregnancy. Participants' male partners had little influence on participants' opinions about, or use of, the spermicides. Although previous analysis showed that both spermicides were associated with high pregnancy rates, they were both highly acceptable to most women.

A dosing study of nonoxynol-9 and genital irritation.

The objective of the study was to assess the symptoms and signs of genital irritation produced by different frequencies of nonoxynol-9 (N-9) use. Thirty-five women were randomized to each of 5 groups and used a vaginal suppository for 2 weeks. Group 1: N-9 once every other day; Group 2: N-9 once a day; Group 3: N-9 twice a day; Group 4: N-9 4 times a day; and Group 5: placebo 4 times a day. Study women were examined at admission, one week and 2 weeks with a colposcope for erythema and epithelial disruption, and were interviewed about vaginal itching and burning. The rates of reported symptoms for N-9 users were not significantly different from that of placebo users. The rate of epithelial disruption for women using N-9 every other day was essentially the same as that of women using placebo. The rates of epithelial disruption for women using N-9 1/day and 2/day were 2.5 times greater than that of placebo users. The rate of epithelial disruption for women using N-9 4/day was five times greater than that of placebo users. Genital irritation was located primarily on the vagina or cervix, and vulvitis was not a significant problem. Women who infrequently use N-9 products may not experience an increase in genital irritation. Women who choose to use N-9 frequently may experience an increase in epithelial disruption.