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Clinical and Experimental Obstetrics & Gynecology  2020, Vol. 47 Issue (4): 516-518    DOI: 10.31083/j.ceog.2020.04.5304
Original Research Previous articles | Next articles
Proof of concept study of a novel bioadhesive clindamycin phosphate 2% vaginal gel to treat bacterial vaginosis
A. Dupre1, H.H. Alur2, D.R. Friend3, *()
1OBGYN Associates of Montgomery, Montgomery, AL, United States
2Trilogic Pharma, Montgomery, AL, United States
3Daré Bioscience, Inc., San Diego, CA, United States
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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.

Key words:  Bacterial vaginosis      Clindamycin phosphate      Vaginal gel     
Submitted:  10 July 2019      Accepted:  23 September 2019      Published:  15 August 2020     
Fund: Van Yuzuncu Yil University the scientific research program
*Corresponding Author(s):  D.R. Friend     E-mail:  dfriend@darebioscience.com

Cite this article: 

A. Dupre, H.H. Alur, D.R. Friend. Proof of concept study of a novel bioadhesive clindamycin phosphate 2% vaginal gel to treat bacterial vaginosis. Clinical and Experimental Obstetrics & Gynecology, 2020, 47(4): 516-518.

URL: 

https://ceog.imrpress.com/EN/10.31083/j.ceog.2020.04.5304     OR     https://ceog.imrpress.com/EN/Y2020/V47/I4/516

Table 1  — Summary of clinical, bacteriologic, and therapeutic cure.
Study Visit Clinical Cure Bacteriologic Cure Therapeutic Cure
Visit 2 24 of 28 (86%) 4 of 7 (57%) 4 of 7 (57%)
Visit 3 23 of 24 (96%) 7 of 9 (78%) 6 of 9 (67%)
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