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
AIM: To compare the effectiveness of an acid-buffering formulation gel (ACIDFORM) with metronidazole gel in the treatment of symptomatic bacterial vaginosis (BV). METHODS: After a confirmed diagnosis of BV according to the criteria established by Nugent and Amsel, 30 nonpregnant women were enrolled in a randomized, double-blind clinical study. The women were randomly assigned to receive either 5 g ACIDFORM gel (n = 13) or 10% metronidazole gel (n = 17) intravaginally once daily for five consecutive days. Participants were evaluated in two follow-up visits (7-12 days and 28-35 days after treatment). Therapeutic success was defined as the presence of less than three of Amsel's criteria. If three or more criteria were present at first or second follow-up visit, the woman was excluded from the study and treated orally with metronidazole. Nugent scores were recorded at each visit but these were not used to define cure. RESULTS: At the first follow-up visit, 15 (88%) of the women in the metronidazole group were cured compared with only three (23%) in the ACIDFORM group (P < 0.001). The remaining 12 women (10 of the ACIDFORM group and two of the metronidazole group) were considered as failure and were treated orally with metronidazole. At the second follow-up visit, two of the ACIDFORM-treated women and six of the metronidazole-treated women presented recurrent BV. Four women in the ACIDFORM group and one in the metronidazole group reported occasional burning and itching during product use. CONCLUSION: ACIDFORM gel was significantly less effective than high-dose metronidazole gel for the treatment of symptomatic BV.
Assuntos
Antibacterianos/uso terapêutico , Géis/uso terapêutico , Metronidazol/uso terapêutico , Vaginose Bacteriana/tratamento farmacológico , Administração Intravaginal , Adulto , Esquema de Medicação , Métodos Epidemiológicos , Feminino , Humanos , Recidiva , Resultado do Tratamento , Cremes, Espumas e Géis Vaginais , Vaginose Bacteriana/diagnósticoRESUMO
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.
Assuntos
Anticoncepcionais Pós-Coito/administração & dosagem , Géis/administração & dosagem , Nonoxinol/administração & dosagem , Espermicidas/administração & dosagem , Cremes, Espumas e Géis Vaginais/administração & dosagem , Administração Intravaginal , Adulto , Soluções Tampão , Coito , Estudos Cross-Over , Método Duplo-Cego , Feminino , Humanos , Masculino , Ciclo Menstrual , Pessoa de Meia-Idade , Motilidade dos Espermatozoides/efeitos dos fármacos , Resultado do Tratamento , Esfregaço VaginalRESUMO
The rapid spread of HIV/AIDS in the female population increases the urgency of developing new formulations that offer protection from this disease as well as other sexually transmitted infections. In many cultures, women do not readily accept touching their genitals or inserting products into their vaginas. Information on this subject was collected during a study involving 635 women in Brazil to determine the preferred attributes of vaginal products. Seventy-six percent would use an idealized contraceptive method that offered dual protection even though it could only be inserted with a finger and 96% would use this method if it could only be placed with an applicator. Qualitative analyses of responses to open questions suggest that the majority of Brazilian women studied did not like to touch their vagina with their finger or to insert devices. Although the introduction of safe and effective vaginal microbicides into many cultural settings can be successful, it should be accompanied by significant efforts to educate women about their bodies.
Assuntos
Anti-Infecciosos/administração & dosagem , Anticoncepcionais Femininos/administração & dosagem , Satisfação do Paciente , Administração Intravaginal , Adolescente , Adulto , Brasil , Feminino , Humanos , Infecções Sexualmente Transmissíveis/prevenção & controle , Cremes, Espumas e Géis Vaginais , Saúde da MulherRESUMO
As doenças sexualmente transmissíveis (DST) têm sido debatidas no ambiente científico e nos meios de comunicaçäo de massa, em especial, por sua associaçäo a maior risco de infecçäo pelo Vírus da Imunodeficiência Humana (HIV). Estudou-se a adoçäo de comportamentos por mulheres para proteçäo das DST, tal como a associaçäo destes a variáveis sócio-econômicas e demográficas. Trata-se de estudo descritivo, com dados secundários de pesquisa feita em Campinas, Säo Paulo, na qual foram entrevistadas 635 mulheres selecionadas mediante a técnica de amostragem "bola de neve". Foram classificadas em: adolescentes e adultas de status sócio-econômico médio-alto ou baixo. Grande proporçäo delas näo se prevenia das DST, em particular, as de status baixo. Em todos os grupos, o condom masculino foi o método de prevençäo mais referido. Houve associaçäo negativa entre parceiro fixo e uso de condom, e a principal razäo para näo usá-lo foi "só ter um parceiro e confiar nele". Em meio às adolescentes, ocorreu associaçäo positiva entre escolaridade acima da oitava série e uso de condom, bem como negativa entre idade e uso desse método. Entre adultas o uso exclusivo de condom esteve, em geral, positivamente associado a status sócio-econômico.