RESUMO
BACKGROUND: ACIDFORM is a microbicidal and contraceptive candidate with strong buffering capacity. METHODS: This was a Phase I blinded, randomized and crossover clinical study on two products, ACIDFORM and a commercial nonoxynol-9 (N-9) product (2%), evaluating their vaginal safety in 20 couples aged between 19 and 45 years. The women had regular menses, underwent previous tubal ligation, were not breast-feeding, had no vaginal sign and symptom and were in a stable partnership; both partners had no previous STI. Colposcopy, vaginal microbiology, inflammation markers and subject complaints were studied after coitus. Women were randomly assigned sequentially to receive ACIDFORM 0-30 min (0-30 min before intercourse), ACIDFORM 8-10 h (8-10 h before intercourse) or N-9 0-30 min after a control cycle. RESULTS: Mild/moderate vulvar irritation was observed in five postcoital test colposcopies, burning and pruritus were reported in six treated cycles and non-irritation-related symptoms were found in five cycles with different treatments. No difference in vaginal pH, Nugent scores, H2O2-producing lactobacillus or leukocytes and interleukin 6 in the cervicovaginal lavage was found between the treatment and control cycles. CONCLUSIONS: ACIDFORM appears to be safe for clinical use once a day. There is a potential spermicidal-microbicidal role for ACIDFORM as a vaginal flora helper or as a vehicle for products, except N-9.
Assuntos
Nonoxinol/efeitos adversos , Espermicidas/efeitos adversos , Vagina/efeitos dos fármacos , Adulto , Anti-Infecciosos Locais/efeitos adversos , Feminino , Humanos , Concentração de Íons de Hidrogênio , Masculino , Vagina/microbiologiaRESUMO
Vaginal tolerance tests were performed with a new potential microbicidal and spermicidal product, an acid-buffering vaginal gel (Acidform) without or with nonoxynol-9 (N-9). The potential advantages over other vaginal products include keeping a low pH, decrease of the irritating effect of N-9 on the cervix or vaginal mucosa associated with greater retention of the product after application, and decreasing "messiness" as compared to other vaginal products. Three groups of six women were admitted and randomly assigned to use Acidform with 0%, 2.5%, and 5% N-9. Colposcopic evaluation for vulvar, vaginal, and cervical signs of irritation was performed and photographs were taken, following a specific World Health Organization protocol, at time 0, and after 24 h and 6 days of application of the gel. No irritation or symptom was reported by users of Acidform without N-9. A generalized and intense erythema in cervix was observed in 10 of 12 Acidform/N-9 users and abrasion occurred in nine of them. Vulvar irritation was seen in seven of these 10 volunteers. N-9 concentration in the gel (2.5% or 5.0%) was not related to the findings. No ulcer, exulceration, or de-epithelialization was observed. Acidform without N-9 was well tolerated by volunteers, but it was unable to protect the cervix, vagina, and vulva from the N-9 effects.
Assuntos
Nonoxinol/efeitos adversos , Espermicidas/efeitos adversos , Vagina/fisiologia , Cremes, Espumas e Géis Vaginais/farmacologia , Adulto , Colo do Útero/efeitos dos fármacos , Colo do Útero/patologia , Colo do Útero/fisiologia , Colposcopia , Método Duplo-Cego , Eritema/patologia , Feminino , Géis , Humanos , Concentração de Íons de Hidrogênio , Contagem de Leucócitos , Pessoa de Meia-Idade , Infecções Sexualmente Transmissíveis/prevenção & controle , Vagina/efeitos dos fármacos , Vagina/patologia , Vulva/efeitos dos fármacos , Vulva/patologia , Vulva/fisiologiaRESUMO
The mean rupture time, after its vaginal insertion, of a new modified soft jelly capsule containing nonoxynol-9 (DF-486) was investigated in 40 women. The subjects were randomly allocated to 8 study groups. The capsules remained in the vagina from 2-13 minutes. Vaginal infection, vaginal dryness, and multiparity, were recorded. Capsule rupture was not observed at minute 2; 20% of capsules that remained in the vagina 3 minutes suffered rupture, as did 80% of capsules that remained 4, 5 and 7 minutes, and 100% of those remaining 9 minutes or more. The mean rupture time of the studied capsules was 8.2 minutes with 95% confidence limits of 6.2 and 8.8 minutes. At minutes 2-7, vaginal infection, dryness and tone diminution probably accounted for lack of rupture; after minute 7, these factors did not influence capsule rupture.
Assuntos
Polietilenoglicóis/administração & dosagem , Espermicidas/administração & dosagem , Administração Intravaginal , Adulto , Cápsulas , Estudos de Avaliação como Assunto , Feminino , Humanos , Nonoxinol , Polietilenoglicóis/efeitos adversos , Espermicidas/efeitos adversos , Fatores de TempoRESUMO
Epidemiological Research in the area of reproductive toxicology, might be defined as the study of all possible toxic factors modifying the human reproductive system, in one way or another, positively or negatively, looking forward to strengthen the former and try to reduce the latter. Only to show the magnitude of the subject we are dealing with, it is enough to think on the high figures of newborns with birth defects and the lives lost each year to defective fetal development resulting in infant death, spontaneous abortion stillbirths. Study methods in reproductive epidemiology, in contrast to general epidemiology, are only observational. Experimental studies are impossible due to ethical reasons. The different types and observational epidemiological studies are described and examples on reproctive toxicology are given