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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

Primary Purpose

BACTERIAL VAGINOSIS, Signs and Symptoms to be Evaluated and Recorded Include, Vaginal Discharge Color, Odor, and Consistency

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
clindamycin phosphate vaginal cream 2%
placebo
Sponsored by
Actavis Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for BACTERIAL VAGINOSIS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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).
    • Table 1: Nugent Scoring System (0-10) for Gram-stained Vaginal Smears (a)
    • Score (b) Lactobacillus morphotypes Gardnerella and Bacteroides spp. morphotypes Curved gram-variable rods
    • 0 4+ 0 0
    • 1 3+ 1+ 1+ or 2+
    • 2 2+ 2+ 3+ or 4+
    • 3 1+ 3+
    • 4 0 4+

Source: Nugent, R. P., M. A. Krohn, and S. L. Hillier. Reliability of diagnosing bacterial vaginosis is improved by a standardized method of Gram stain interpretation. J. Clin. Microbial. 1991; 29: 297-301.

  • Morphotypes are scored as the average number seen per oil immersion field. Note that less weight is given to curved gram-variable rods. Total score = lactobacilli + G. vaginalis and Bacteroides spp/ + curved rods.
  • 0, No morphotypes present; 1, <1 morphotype present; 2, 1 to 4 morphotypes present; 3, 5 to 30 morphotypes present; 4, 30 or more morphotypes present.

Exclusion Criteria:

  1. Female subjects who are pregnant, nursing or planning to become pregnant during study participation.
  2. Menstruating when diagnosis of bacterial vaginosis is determined at Baseline visit.
  3. Primary or secondary immunodeficiency.
  4. Severe liver disease.
  5. History of regional enteritis, ulcerative colitis, or a history of "antibiotic-associated" colitis.
  6. Evidence of any vulvovaginitis other than bacterial vaginosis. (e.g., candidiasis, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Herpes simplex).
  7. Subjects with visible signs of HPV infection, i.e. visible warts.
  8. Subject with another vaginal or vulvar condition, which would confound the interpretation of clinical response.
  9. Subject will be under treatment during the study period for cervical intraepithelial neoplasia (CIN) or cervical carcinoma.
  10. History of hypersensitivity to clindamycin, lincomycin, or any of the components of the vaginal creams.
  11. Use within 2 weeks prior to baseline of 1) topical or systemic antibiotics or 2) topical or systemic antifungal.
  12. Use of spermicides, tampons, douches, diaphragms, condoms within 48 hours of the baseline visit.
  13. Concurrent use of systemic corticosteroids or systemic antibiotics.
  14. Unwilling or unable to comply with the protocol requirements.
  15. Subjects who have participated in an investigational drug study (i.e., subjects have been treated with an investigational drug) within 30 days prior to baseline will be excluded from study participation. Subjects who are participating in non-treatment studies such as observational studies or registry studies can be considered for inclusion.
  16. Subjects who have been previously enrolled in this study.

Sites / Locations

  • Akesis Investigator site 5
  • Akesis Investigator site 12
  • Akesis investigator site 6
  • Akesis Investigator site 1
  • Akesis investigator site 14
  • Akesis investigator site 17
  • Akesis investigator site 8
  • Akesis Investigator site 10
  • Akesis Investigator site 9
  • Akesis Investigator site 15
  • Akesis investigator site 16
  • Akesis investigator site 11
  • Akesis investigator site 13
  • Akesis Investigator site 7
  • Akesis investigator site 18
  • Akesis investigator site 3
  • Akesis investigator site 4
  • Akesis Investigator site 2

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

test product

reference product

placebo

Arm Description

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.)

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™)

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

Outcomes

Primary Outcome Measures

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: 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, The whiff test is negative for any amine ("fishy") odor, The saline wet mount is negative for clue cells, 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: Lactobacillus: large gram positive rods, Gardnerella / Bacteroides spp: Small gram variable coccobacilli/small Gram negative rods, Mobiluncus spp.: thin, curved Gram variable rods

Secondary Outcome Measures

Full Information

First Posted
August 4, 2014
Last Updated
January 14, 2020
Sponsor
Actavis Inc.
Collaborators
Watson Laboratories, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02210689
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Actavis Inc.
Collaborators
Watson Laboratories, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The study treatment period will be 1 day. Subject participation is 22-30 days. Expected study duration is 10 to 12 months. The study will enroll in up to 30 clinical sites. Test Product: 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.) Reference Product: 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™) Placebo Control: One single-dose, pre-filled disposable applicator delivering approximately 5 g of cream containing vehicle of the test product (Watson Laboratories, Inc.) Dose and Mode A single applicator of investigational product cream will be administered of Administration once intravaginally at any time of the day. The subject participation is 22-30 days (drug administration for 1 day).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
604 (Actual)

8. Arms, Groups, and Interventions

Arm Title
test product
Arm Type
Experimental
Arm Description
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.)
Arm Title
reference product
Arm Type
Active Comparator
Arm Description
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™)
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
One single-dose, pre-filled disposable applicator delivering approximately 5 g of cream containing vehicle of the test product (Watson Laboratories, Inc.)
Intervention Type
Drug
Intervention Name(s)
clindamycin phosphate vaginal cream 2%
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
vehicle used as placebo
Primary Outcome Measure Information:
Title
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).
Description
Clinical Cure is defined as resolution of clinical signs and symptoms from entry visit as follows: 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, The whiff test is negative for any amine ("fishy") odor, The saline wet mount is negative for clue cells, 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: Lactobacillus: large gram positive rods, Gardnerella / Bacteroides spp: Small gram variable coccobacilli/small Gram negative rods, Mobiluncus spp.: thin, curved Gram variable rods
Time Frame
22 to 30 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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). Table 1: Nugent Scoring System (0-10) for Gram-stained Vaginal Smears (a) Score (b) Lactobacillus morphotypes Gardnerella and Bacteroides spp. morphotypes Curved gram-variable rods 0 4+ 0 0 1 3+ 1+ 1+ or 2+ 2 2+ 2+ 3+ or 4+ 3 1+ 3+ 4 0 4+ Source: Nugent, R. P., M. A. Krohn, and S. L. Hillier. Reliability of diagnosing bacterial vaginosis is improved by a standardized method of Gram stain interpretation. J. Clin. Microbial. 1991; 29: 297-301. Morphotypes are scored as the average number seen per oil immersion field. Note that less weight is given to curved gram-variable rods. Total score = lactobacilli + G. vaginalis and Bacteroides spp/ + curved rods. 0, No morphotypes present; 1, <1 morphotype present; 2, 1 to 4 morphotypes present; 3, 5 to 30 morphotypes present; 4, 30 or more morphotypes present. Exclusion Criteria: 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 participated in an investigational drug study (i.e., subjects have been treated with an investigational drug) within 30 days prior to baseline will be excluded from study participation. Subjects who are participating in non-treatment studies such as observational studies or registry studies can be considered for inclusion. Subjects who have been previously enrolled in this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
nageshwar r thudi, Ph.D., CCRP
Organizational Affiliation
Actavis Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Akesis Investigator site 5
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Akesis Investigator site 12
City
La Mesa
State/Province
California
Country
United States
Facility Name
Akesis investigator site 6
City
San Diego
State/Province
California
Country
United States
Facility Name
Akesis Investigator site 1
City
Boynton Beach
State/Province
Florida
Country
United States
Facility Name
Akesis investigator site 14
City
North Miami
State/Province
Florida
Country
United States
Facility Name
Akesis investigator site 17
City
Sanford
State/Province
Florida
ZIP/Postal Code
32771
Country
United States
Facility Name
Akesis investigator site 8
City
Sunrise
State/Province
Florida
Country
United States
Facility Name
Akesis Investigator site 10
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
Akesis Investigator site 9
City
Roswell
State/Province
Georgia
Country
United States
Facility Name
Akesis Investigator site 15
City
Metairie
State/Province
Louisiana
Country
United States
Facility Name
Akesis investigator site 16
City
Lawrenceville
State/Province
New Jersey
Country
United States
Facility Name
Akesis investigator site 11
City
Port Jefferson
State/Province
New York
Country
United States
Facility Name
Akesis investigator site 13
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Akesis Investigator site 7
City
Jackson
State/Province
Tennessee
Country
United States
Facility Name
Akesis investigator site 18
City
Houston
State/Province
Texas
ZIP/Postal Code
77011
Country
United States
Facility Name
Akesis investigator site 3
City
Santo Domingo
State/Province
Republica Dominicana
Country
Dominican Republic
Facility Name
Akesis investigator site 4
City
Santo Domingo
State/Province
Republica Dominicana
Country
Dominican Republic
Facility Name
Akesis Investigator site 2
City
Ponce
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

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

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