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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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•Actavis Inc.

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

FEMALE

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:
+15 more criteria

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.
+6 more criteria

Locations (18)

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

Key Dates

Start Date

January 1, 2014

Primary Completion Date

October 1, 2014

Completion Date

December 1, 2014

Last Updated

January 28, 2020

Enrollment

604

ACTUAL participants

Conditions

BACTERIAL VAGINOSISSigns and Symptoms to be Evaluated and Recorded IncludeVaginal Discharge Color, Odor, and ConsistencyVulvovaginal Itching and Irritation (Subjective) Absent, Mild, Moderate, or SevereVulvovaginal Inflammation (Objective) Absent, Mild, Moderate, or Severe

Interventions

clindamycin phosphate vaginal cream 2%

DRUG

placebo

OTHER

An Open Single-armed Investigation to Evaluate the Safety of pHyph Following a Prolonged Treatment Duration in Adult Women With Bacterial Vaginosis

NCT07394777

Bacterial Vaginosis (BV)

View study

ENROLLING_BY_INVITATION

Vaginal Ecosystem and Network in the United States Study

NCT06472765

Bacterial VaginosisCandidiasis+9 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 28, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Inclusion Criteria

Exclusion Criteria

An Open Single-armed Investigation to Evaluate the Safety of pHyph Following a Prolonged Treatment Duration in Adult Women With Bacterial Vaginosis

Vaginal Ecosystem and Network in the United States Study

A First-in-human Safety Trial of BNT331 Administered as Single Ascending Doses in Healthy Women and as Multiple Ascending Doses in Women Diagnosed With Bacterial Vaginosis

Feasibility of an Oral Intervention for Sexual Health in Transgender Men

A Randomised, Partly-blinded Investigation to Evaluate the Clinical Performance and Safety of pHyph in Adult Women With Bacterial Vaginosis Compared With an Untreated Control Group

Effects of a Vaginal Contraceptive Ring on Vaginal Microbiota and Local Immunity