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

NCT ID: NCT02210689

Last Updated: 2020-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 604 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-12-31

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).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.)

Group Type: EXPERIMENTAL

clindamycin phosphate vaginal cream 2%

Intervention Type: DRUG

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™)

Group Type: ACTIVE_COMPARATOR

clindamycin phosphate vaginal cream 2%

Intervention Type: DRUG

placebo

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

vehicle used as placebo

Interventions

clindamycin phosphate vaginal cream 2%

Intervention Type: DRUG

placebo

vehicle used as placebo

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Watson Laboratories, Inc.

INDUSTRY

Sponsor Role: collaborator

Actavis Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

nageshwar r thudi, Ph.D., CCRP

Role: STUDY_DIRECTOR

Actavis Inc.

Locations

Akesis Investigator site 5

Birmingham, Alabama, United States

Akesis Investigator site 12

La Mesa, California, United States

Akesis investigator site 6

San Diego, California, United States

Akesis Investigator site 1

Boynton Beach, Florida, United States

Akesis investigator site 14

North Miami, Florida, United States

Akesis investigator site 17

Sanford, Florida, United States

Akesis investigator site 8

Sunrise, Florida, United States

Akesis Investigator site 10

West Palm Beach, Florida, United States

Akesis Investigator site 9

Roswell, Georgia, United States

Akesis Investigator site 15

Metairie, Louisiana, United States

Akesis investigator site 16

Lawrenceville, New Jersey, United States

Akesis investigator site 11

Port Jefferson, New York, United States

Akesis investigator site 13

Philadelphia, Pennsylvania, United States

Akesis Investigator site 7

Jackson, Tennessee, United States

Akesis investigator site 18

Houston, Texas, United States

Akesis investigator site 3

Santo Domingo, Republica Dominicana, Dominican Republic

Akesis investigator site 4

Santo Domingo, Republica Dominicana, Dominican Republic

Akesis Investigator site 2

Ponce, , Puerto Rico

Countries

United States; Dominican Republic; Puerto Rico

Other Identifiers

13-1052

Identifier Type: -

Identifier Source: org_study_id