A Multi-center, Double-blind, Randomized Study, Comparing Clindamycin Phosphate Vaginal Cream 2% (Watson Laboratories, Inc.) to Clindesse® (Ther-Rx™, Clindamyin Phosphate Vaginal Cream 2%) and Both Active Treatments to a Placebo Control in the Treatment of Bacterial Vaginosis in Non-pregnant Women
United States604 participantsStarted 2014-01
Plain-language summary
A multi-center, double-blind, randomized, placebo controlled, parallel-group study, comparing Clindamycin phosphate vaginal cream 2% (Watson Laboratories, Inc.) to Clindesse® (Ther-Rx™, Clindamyin Phosphate Vaginal Cream 2%) and both active treatments to a placebo control in the treatment of bacterial vaginosis in non-pregnant women.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits and must provide the written informed consent prior to any study related procedure being performed.
✓. Healthy non-pregnant female aged ≥ 18 years with no known medical conditions that, in the investigator's opinion, may interfere with study participation or may interfere with the evaluation of bacterial vaginosis.
✓. Female subjects of childbearing potential (excluding women who are surgically sterilized or postmenopausal for at least 1 year), in addition to having a negative urine pregnancy test must be willing to use an acceptable form of birth control during the study from the day of the first dose administration to the Visit 2 Test-of-cure. For the purpose of this study the following are considered acceptable methods of birth control:
✓. Willing to refrain from using any vaginal product (e.g., spermicide, tampon, douche, diaphragm, or condom) other than study product, on study Days 1-7, for 48 hours prior to the first dose of study product, and for 48 hours prior to Visit 2 Test-of-cure.
✓. Diagnosis of bacterial vaginosis, defined as the presence of all of the following:
Exclusion criteria
What they're measuring
1
Number of Participants With Both a Clinical and a Bacteriological Cure (Nugent Score <4), Evaluated at Visit 2 Test-of-cure (Study Day 22-30).
. Female subjects who are pregnant, nursing or planning to become pregnant during study participation.
✕. Menstruating when diagnosis of bacterial vaginosis is determined at Baseline visit.
✕. Primary or secondary immunodeficiency.
✕. Severe liver disease.
✕. History of regional enteritis, ulcerative colitis, or a history of "antibiotic-associated" colitis.
✕. Evidence of any vulvovaginitis other than bacterial vaginosis. (e.g., candidiasis, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Herpes simplex).
✕. Subjects with visible signs of HPV infection, i.e. visible warts.
✕. Subject with another vaginal or vulvar condition, which would confound the interpretation of clinical response.