methylcellulose and Vaginal-Diseases

To determine the safety and acceptability of vaginal application of Carraguard, a carrageenan-derived candidate microbicide gel.. A randomized, placebo-controlled, triple-blinded clinical trial was conducted in Chiang Rai, northern Thailand.. Women were asked to insert one applicator of study gel vaginally at least three times per week (with or without sex) and to use gel with condoms every time they had sex. Safety was assessed by visual inspection of the vagina and cervix, changes in vaginal flora and self-reported symptoms at day 14, month 1 and then monthly for up to 1 year. Acceptability was assessed through reported use of the gel, return of used and unused applicators, and quarterly interviews.. One hundred sixty-five women were randomized: 83 to Carraguard and 82 to the placebo (methylcellulose gel) group. Study gel use was similarly high in both groups throughout the trial with an average of four applicators per week. Carraguard use was not associated with abnormal genital clinical findings, abnormal vaginal flora, Pap smear abnormalities or other abnormal clinical signs or symptoms. Adverse events were mostly mild, not attributed to gel use, and similarly distributed between groups. Participants in both groups reported high acceptability.. Carraguard can safely be used an average of four times per week with or without sex and is acceptable to Thai women. A Phase III efficacy trial of Carraguard is warranted and is currently ongoing in South Africa.

Topics: Administration, Intravaginal; Anti-Infective Agents; Drug Delivery Systems; Female; Gels; Humans; Methylcellulose; Patient Acceptance of Health Care; Placebos; Safety; Sexual Behavior; Sexually Transmitted Diseases; Thailand; Vaginal Diseases

In this study, the efficacy of metronidazole as a local spermicidal agent was investigated. The drug was formulated in a concentration of 5% as an acid gel for vaginal application as a local contraception. The minimum spermicidal concentration of metronidazole was evaluated in-vitro and found to be 0.2% w/v. The formulated gel showed instant immobilization and death of all sperm within 30 s. A clinical study was conducted to determine the drug concentrations in vaginal secretions of healthy women and women with symptoms suggesting genital tract infection every 15 min for a 1-h period after application of 1 g of the gel in the vagina. Drug concentrations in the infected group were significantly lower (P < 0.05) than those in the healthy group at all time intervals. The drug concentrations in vaginal secretions after 1 h of vaginal medication remained above the determined minimum spermicidal concentration (0.2%) in the two groups. Measurement of vaginal pH before and after medication revealed a significant drop (P < 0.05) in pH to its normal value in both healthy and infected groups as a result of gel application. In conclusion, the designed gel has potential advantages of achieving a long retention time and effective drug concentrations in the vagina for at least 1 h after application, and of maintaining vaginal pH within its normal range.

Topics: Acetic Acid; Administration, Intravaginal; Adult; Bacterial Infections; Body Fluids; Contraception; Drug Combinations; Female; Gels; Humans; Hydrogen-Ion Concentration; In Vitro Techniques; Male; Methylcellulose; Metronidazole; Middle Aged; Rheology; Solubility; Spermatocidal Agents; Vagina; Vaginal Diseases

To evaluate the feasibility and acceptability of the Micralax applicator and of methyl cellulose placebo gel for use in vaginal microbicide clinical trials.. A two-centre prospective study following women for 2 months.. Two primary health care clinics in South Africa.. Female volunteers (n = 28) 18 years or older who were HIV negative and had no clinically detectable genital tract abnormalities or reproductive tract infections.. Participants used pre-filled Micralax applicators to apply methyl cellulose gel every other day, as well as up to 1 h before to every episode of vaginal sex.. Consistency in the weight of gel dispensed per application; side-effects attributed to applicator or gel use; and acceptability of the applicator and of the gel.. Over a 2 month follow-up period the 22 women completing the study reported no adverse events related to gel or applicator use. The Micralax applicator proved acceptable. The gel was not too messy and did not reduce sexual frequency or pleasure. On average, the applicator dispensed 4.7 ml per use (close to the 4 ml planned).. The Micralax applicator performs well as a delivery system for potential vaginal microbicides; and methyl cellulose is an appropriate placebo for future microbicide trials.

Topics: Administration, Intravaginal; Adolescent; Adult; Anti-Infective Agents; Drug Delivery Systems; Female; Gels; Humans; Methylcellulose; Patient Acceptance of Health Care; Placebos; Vaginal Diseases