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

NCT02210689 | Completed Phase 3 Results

• 1 other identifier: 13-1052
• Study Type: interventional
• Target: 604
• Locations: 3 countries
• Sites: 18

Brief 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.

Conditions

BACTERIAL VAGINOSIS; Signs and Symptoms to be Evaluated and Recorded Include; Vaginal Discharge Color, Odor, and Consistency; Vulvovaginal Itching and Irritation (Subjective) Absent, Mild, Moderate, or Severe; Vulvovaginal Inflammation (Objective) Absent, Mild, Moderate, or Severe

Outcome Measures

Primary Outcomes (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).

  Clinical Cure is defined as resolution of clinical signs and symptoms from entry visit as follows: 1. The original discharge characteristic of bacterial vaginosis has returned to a normal physiological vaginal discharge which varies in appearance and consistency depending on the menstrual cycle, 2. The whiff test is negative for any amine ("fishy") odor, 3. The saline wet mount is negative for clue cells, 4. Vaginal fluid pH is \< 4.7, using pH paper that measures from 3.6 to 6.1. A Bacteriological cure is defined as a Nugent score \< 4. The system used a 0-4 scale (Nugent Scoring System 0-10 for Gram-Stained Vaginal Smears) for evaluation of vaginal flora, based on the weighted sum of the following 3 bacterial morphotypes scores calculated from slide examination under oil immersion field: 1. Lactobacillus: large gram positive rods, 2. Gardnerella / Bacteroides spp: Small gram variable coccobacilli/small Gram negative rods, 3. Mobiluncus spp.: thin, curved Gram variable rods

  22 to 30 days

Study Arms (3)

test product

EXPERIMENTAL

One single-dose, pre-filled disposable applicator delivering approximately 5 g of cream containing approximately 100 mg of clindamycin phosphate vaginal cream 2% (Watson Laboratories, Inc.)

Drug: clindamycin phosphate vaginal cream 2%

reference product

ACTIVE COMPARATOR

One single-dose, pre-filled disposable applicator delivering approximately 5 g of cream containing approximately 100 mg of Clindesse® (clindamycin phosphate vaginal cream 2% ) (Ther-Rx™)

Drug: clindamycin phosphate vaginal cream 2%

placebo

PLACEBO COMPARATOR

One single-dose, pre-filled disposable applicator delivering approximately 5 g of cream containing vehicle of the test product (Watson Laboratories, Inc.)

Other: placebo

Interventions

clindamycin phosphate vaginal cream 2% DRUG

reference product; test product

placebo OTHER

vehicle used as placebo

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Oral or injectable contraceptives
• Contraceptive patches
• Depo-Provera® (stabilized for at least 3 months); Implanon™ (contraceptive implant), or abstinence with one of the above-listed methods of birth control should the Subject become sexually active.
• A sterile sexual partner is NOT considered an adequate form of birth control.
• Willing to refrain from sexual intercourse on study days 1-7 and for 48 hours prior to Visit 2 Test-of-cure.
• 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:
• Clinical diagnosis of bacterial vaginosis (e.g., thin, homogenous vaginal discharge associated with minimal or absent pruritus or inflammation AND
• Saline wet mount of vaginal discharge demonstrating the proportion of clue cell to be ≥ 20% of the total epithelial cells AND
• Vaginal pH \> 4.5, using pH paper that measures from 4.0-6.0 AND
• Positive "whiff test" after addition of a drop of 10% KOH to vaginal discharge)
• Gram stain Nugent score ≥ 4 on first day of dosing (study day 1) (per Table 1 below).

You may not qualify if:

• 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.
• Subject will be under treatment during the study period for cervical intraepithelial neoplasia (CIN) or cervical carcinoma.
• History of hypersensitivity to clindamycin, lincomycin, or any of the components of the vaginal creams.
• Use within 2 weeks prior to baseline of 1) topical or systemic antibiotics or 2) topical or systemic antifungal.
• Use of spermicides, tampons, douches, diaphragms, condoms within 48 hours of the baseline visit.
• Concurrent use of systemic corticosteroids or systemic antibiotics.
• Unwilling or unable to comply with the protocol requirements.
• Subjects who have been previously enrolled in this study.

Sponsors & Collaborators

• Actavis Inc.: lead
• Watson Laboratories, Inc.: collaborator

Study Sites (18)

Akesis Investigator site 5

Birmingham, Alabama, United States

Location

Akesis Investigator site 12

La Mesa, California, United States

Location

Akesis investigator site 6

San Diego, California, United States

Location

Akesis Investigator site 1

Boynton Beach, Florida, United States

Location

Akesis investigator site 14

North Miami, Florida, United States

Location

Akesis investigator site 17

Sanford, Florida, 32771, United States

Location

Akesis investigator site 8

Sunrise, Florida, United States

Location

Akesis Investigator site 10

West Palm Beach, Florida, United States

Location

Akesis Investigator site 9

Roswell, Georgia, United States

Location

Akesis Investigator site 15

Metairie, Louisiana, United States

Location

Akesis investigator site 16

Lawrenceville, New Jersey, United States

Location

Akesis investigator site 11

Port Jefferson, New York, United States

Location

Akesis investigator site 13

Philadelphia, Pennsylvania, United States

Location

Akesis Investigator site 7

Jackson, Tennessee, United States

Location

Akesis investigator site 18

Houston, Texas, 77011, United States

Location

Akesis investigator site 3

Santo Domingo, Republica Dominicana, Dominican Republic

Location

Akesis investigator site 4

Santo Domingo, Republica Dominicana, Dominican Republic

Location

Akesis Investigator site 2

Ponce, Puerto Rico

Location

MeSH Terms

Conditions

Vaginosis, Bacterial; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Senior Director, CE Studies
• Organization: Teva Pharmaceuticals USA. Inc.

USMedInfo@tevapharm.com

1-888-483-8279

Study Officials

• nageshwar r thudi, Ph.D., CCRP

  Actavis Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2014
• First Posted: August 7, 2014
• Study Start: January 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 28, 2020
• Results First Posted: December 26, 2019

Record last verified: 2020-01

Locations

PR (1); DO (2); US (15)