A randomized Phase I vaginal safety study of three concentrations of C31G vs. Extra Strength Gynol II

• Published in: Contraception (Stoneham) Vol. 70; no. 3; pp. 233 - 240
• Main Authors: Mauck, Christine K., Weiner, Debra H., Creinin, Mitchell D., Barnhart, Kurt T., Callahan, Marianne M., Bax, Richard
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.09.2004; Elsevier Science
• Subjects: Adolescent; Adult; Anti-Infective Agents - administration & dosage; Anti-Infective Agents - adverse effects; Betaine - administration & dosage; Betaine - adverse effects; Betaine - analogs & derivatives; Biological and medical sciences; Birth control; Cervix; Colposcopy; Contraception; Double-Blind Method; Fatty Acids, Unsaturated - administration & dosage; Fatty Acids, Unsaturated - adverse effects; Female; Genital irritation; Genital system. Reproduction; Genitalia, Female - drug effects; Gynecology. Andrology. Obstetrics; Humans; Medical sciences; Microbicide; Middle Aged; Nonoxynol - administration & dosage; Nonoxynol - adverse effects; Other methods of contraception. Sterilization; Patient Satisfaction; Pharmacology. Drug treatments; Phase I clinical trial; Spermatocidal Agents - administration & dosage; Spermatocidal Agents - adverse effects; Spermicide; Vagina; Vagina - drug effects; Vaginitis - chemically induced; Genital irritation; Phase I clinical trial; Microbicide; Vagina; Contraception; Cervix; Spermicide; Intravaginal administration; Amphoteric surfactant; Toxicity; Uterine cervix; Female genital diseases; Randomization; Activity concentration relation; Phase I trial; Nonoxinol; Contraceptive; Antibacterial agent; Comparative study; Irritation

C31G is an antimicrobial and spermicidal agent that contains two surface-active compounds, cetyl betaine and myristamine oxide. It is being developed as a vaginal microbicide and contraceptive. Three C31G concentrations (0.5%, 1.0% and 1.7%) were tested and compared with Extra Strength Gynol II®, a...