IMR Press / CEOG / Volume 47 / Issue 4 / DOI: 10.31083/j.ceog.2020.04.5304
Open Access Original Research
Proof of concept study of a novel bioadhesive clindamycin phosphate 2% vaginal gel to treat bacterial vaginosis
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1 OBGYN Associates of Montgomery, Montgomery, AL, United States
2 Trilogic Pharma, Montgomery, AL, United States
3 Daré Bioscience, Inc., San Diego, CA, United States
*Correspondence: dfriend@darebioscience.com (DAVID R. FRIEND)
Clin. Exp. Obstet. Gynecol. 2020, 47(4), 516–518; https://doi.org/10.31083/j.ceog.2020.04.5304
Submitted: 10 July 2019 | Accepted: 23 September 2019 | Published: 15 August 2020
Copyright: © 2020 Dupre et al. Published by IMR Press.
This is an open access article under the CC BY 4.0 license http://creativecommons.org/licenses/by/4.0/.
Abstract

The objective of the study was to evaluate the efficacy and safety of a novel single 2% clindamycin phosphate vaginal gel for the treatment of bacterial vaginosis (BV). The vaginal gel, a thermosetting bioadhesive formulation containing 2% clindamycin phosphate, was studied in a single center, single arm, open-label study. Patients (n = 30) were screened for BV using the four Amsel criteria (visit 1). A subset of ten women were also assessed using Nugent scores. Eligible patients were consented and provided a single dose of 2.0% clindamycin phosphate gel in a prefilled vaginal applicator (5-gram total dose). Patients returned to the clinic 7 to 14 days (visit 2) after dosing and again between 21 and 30 days (visit 3). Two subjects were excluded from cure rate calculations. Of the evaluable 28 patients, 24 (86%) were successfully treated (clinical cure) with a single dose of 2% clindamycin gel at visit 2. Of the ten patients evaluated for Nugent scoring, seven subjects were evaluable for bacteriologic cure. After a single dose of 2% clindamycin gel, four of seven (57%), and four of seven (57%) had a bacteriologic and therapeutic response, respectively. Of the 24 women who completed visit 2 and were cured based on Amsel criteria, 23 (96%) remained cured at visit 3. Of the subset of ten patients evaluated using Nugent scoring (bacteriologic evaluation), seven of nine (78%) had a score of 3 or less at visit 3. In this group, six of nine women were considered therapeutically cured (67%). There were no reports of adverse reactions, including local reactions to the vaginal gel product over the course of the study. These data support the expanded clinical evaluation of 2% clindamycin gel.

Keywords
Bacterial vaginosis
Clindamycin phosphate
Vaginal gel
Funding
Van Yuzuncu Yil University the scientific research program
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