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A Phase I study of the functional performance, safety and acceptability of the BufferGel Duet.
Contraception. 2008 Feb; 77(2):130-7.C

Abstract

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.

STUDY DESIGN

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.

Authors+Show Affiliations

CONRAD Clinical Research Center, Eastern Virginia Medical School Norfolk, VA 23507, USA. ballagsa@gmail.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase I
Journal Article
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.

Language

eng

PubMed ID

18226678

Citation

Ballagh, Susan A., et al. "A Phase I Study of the Functional Performance, Safety and Acceptability of the BufferGel Duet." Contraception, vol. 77, no. 2, 2008, pp. 130-7.
Ballagh SA, Brache V, Mauck C, et al. A Phase I study of the functional performance, safety and acceptability of the BufferGel Duet. Contraception. 2008;77(2):130-7.
Ballagh, S. A., Brache, V., Mauck, C., Callahan, M. M., Cochon, L., Wheeless, A., & Moench, T. R. (2008). A Phase I study of the functional performance, safety and acceptability of the BufferGel Duet. Contraception, 77(2), 130-7. https://doi.org/10.1016/j.contraception.2007.10.003
Ballagh SA, et al. A Phase I Study of the Functional Performance, Safety and Acceptability of the BufferGel Duet. Contraception. 2008;77(2):130-7. PubMed PMID: 18226678.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A Phase I study of the functional performance, safety and acceptability of the BufferGel Duet. AU - Ballagh,Susan A, AU - Brache,Vivian, AU - Mauck,Christine, AU - Callahan,Marianne M, AU - Cochon,Leila, AU - Wheeless,Angie, AU - Moench,Thomas R, Y1 - 2007/12/27/ PY - 2007/08/29/received PY - 2007/10/20/revised PY - 2007/10/29/accepted PY - 2008/1/30/pubmed PY - 2008/5/13/medline PY - 2008/1/30/entrez SP - 130 EP - 7 JF - Contraception JO - Contraception VL - 77 IS - 2 N2 - 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. STUDY DESIGN: 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. SN - 0010-7824 UR - https://www.unboundmedicine.com/medline/citation/18226678/A_Phase_I_study_of_the_functional_performance_safety_and_acceptability_of_the_BufferGel_Duet_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0010-7824(07)00455-6 DB - PRIME DP - Unbound Medicine ER -