A Phase I study of the functional performance, safety and acceptability of the BufferGel Duet.
BACKGROUND
The purpose of this study was to assess the functional performance of the BufferGel Duet, a buffering microbicide and spermicide gel applied to the cervix and vagina by a novel applicator that also serves as a mechanical barrier.


METHODS
This was a noncomparative Phase I safety trial in 30 healthy couples, aged 20-50 years, at low risk for sexually transmitted infections, who agreed to use the gel-device combination twice in 1 week and respond to detailed questionnaires about their experience. The female participants were examined with colposcopy before and 6-18 h after using the second device.


RESULTS
Based on written instructions alone, 25 women successfully placed and 28 women successfully removed the device. Three women reported feeling the device dislodge around the time of intercourse. The product was equally acceptable to both men and women. Most users concluded that intercourse was the same or better with the device than with no product. About 73% would choose Duet over male condoms, and no one preferred the standard diaphragm. Colposcopic findings were noted in 79% of women with external genital findings (9) or cervicovaginal peeling (18) predominating. Only one finding breached the epithelium. Most product-related adverse events were mild (10/11) and confined to the genitourinary tract.


CONCLUSIONS
The successful placements and acceptability suggest that further product development is warranted and could target over-the-counter use. During increased duration of use or more frequent dosing, cervicovaginal monitoring is advised based on the extent of peeling and external colposcopic findings in this short-term study.
Ballagh
Susan A
SA
CONRAD Clinical Research Center, Eastern Virginia Medical School Norfolk, VA 23507, USA. ballagsa@gmail.com
Brache
Vivian
V
Mauck
Christine
C
Callahan
Marianne M
MM
Cochon
Leila
L
Wheeless
Angie
A
Moench
Thomas R
TR
D000180:Acrylic Resins; D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage*; D003127:Colposcopy; D003274:Contraceptive Devices, Female; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D012449:Safety; D012749:Sexually Transmitted Diseases / Q000517:prevention & control; D013089:Spermatocidal Agents / Q000008:administration & dosage*; D016896:Treatment Outcome; D014566:Urogenital System / Q000187:drug effects; D014621:Vagina / Q000166:cytology / Q000293:injuries / Q000473:pathology*; D014622:Vaginal Creams, Foams, and Jellies / Q000008:administration & dosage / Q000009:adverse effects
D000180:Acrylic Resins; D000998:Antiviral Agents; C420918:BufferGel; D013089:Spermatocidal Agents; D014622:Vaginal Creams, Foams, and Jellies