title: Single and multiple exposure tolerance study of cellulose sulfate gel: a Phase I safety and colposcopy study.
abstract: Vaginally applied gels offer a promising approach for preventing unwanted pregnancies and sexually transmitted infections. Cellulose sulfate (CS) is a non-cytotoxic antifertility agent that also exhibits in vitro antimicrobial activity against sexually transmitted pathogens, including HIV. This was a randomized, double-blinded, Phase I study of 2.5 mL and 5.0 mL doses of 6% CS gel. A single vaginal application of the gel followed by five consecutive daily doses was assessed for genital irritation, safety, vaginal leakage, and product acceptability compared to two controls, Conceptrol, which is a marketed contraceptive gel containing nonoxynol-9, and K-Y jelly. The results suggest that the safety of 6% CS was comparable to that of Conceptrol and K-Y jelly, and it may be associated with less genital irritation. The 2.5 mL dose of CS may be preferable according to the participants' reports of leakage. All the products had similar acceptability profiles.
authors.affiliation: CONRAD Program, Arlington, VA, USA. cmauck@ronrad.org
authors.forename: C
authors.initials: C
authors.lastname: Mauck
authors.forename: D H
authors.initials: DH
authors.lastname: Weiner
authors.forename: S
authors.initials: S
authors.lastname: Ballagh
authors.forename: M
authors.initials: M
authors.lastname: Creinin
authors.forename: D F
authors.initials: DF
authors.lastname: Archer
authors.forename: J
authors.initials: J
authors.lastname: Schwartz
authors.forename: H
authors.initials: H
authors.lastname: Pymar
authors.forename: J J
authors.initials: JJ
authors.lastname: Lai
authors.forename: M
authors.initials: M
authors.lastname: Callahan
mesh_terms: D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D000890:Anti-Infective Agents / Q000494:pharmacology*; D000998:Antiviral Agents / Q000494:pharmacology*; D002482:Cellulose / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000494:pharmacology*; D003127:Colposcopy; D003271:Contraceptive Agents, Female / Q000494:pharmacology*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005782:Gels / Q000008:administration & dosage; D005836:Genitalia, Female / Q000187:drug effects; D005990:Glycerol / Q000494:pharmacology; D006801:Humans; D008875:Middle Aged; D017137:Nonoxynol / Q000494:pharmacology; D010342:Patient Acceptance of Health Care; D010710:Phosphates / Q000494:pharmacology; D011409:Propylene Glycols / Q000494:pharmacology; D012749:Sexually Transmitted Diseases / Q000517:prevention & control; D023422:Skin Irritancy Tests; D013089:Spermatocidal Agents / Q000494:pharmacology*; D013997:Time Factors; D014622:Vaginal Creams, Foams, and Jellies
chemical_list: D000890:Anti-Infective Agents; D000998:Antiviral Agents; D003271:Contraceptive Agents, Female; D005782:Gels; C042973:K-Y jelly; D010710:Phosphates; D011409:Propylene Glycols; D013089:Spermatocidal Agents; D014622:Vaginal Creams, Foams, and Jellies; D017137:Nonoxynol; D002482:Cellulose; C020254:cellulose sulfate; D005990:Glycerol