BACTERIAL VAGINOSISPhase 3NCT02210689
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
A Phase 3 study testing clindamycin phosphate vaginal cream 2% in people with BACTERIAL VAGINOSIS and Signs and Symptoms to be Evaluated and Recorded Include, run by Actavis Inc. at 18 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- BACTERIAL VAGINOSIS, Signs and Symptoms to be Evaluated and Recorded Include, Vaginal Discharge Color, Odor, and Consistency
- What is being tested?
- clindamycin phosphate vaginal cream 2%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 604 participants
- Where
- 18 sitesin 3 countries
- Study dates
- Jan 2014to Dec 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
18 sites in 3 countries.
18 sites in 3 countries
United States15 sites
Akesis Investigator site 5
Birmingham, Alabama
Akesis Investigator site 1
Boynton Beach, Florida
Akesis investigator site 18
Houston, Texas, 77011
Akesis Investigator site 7
Jackson, Tennessee
Akesis Investigator site 12
La Mesa, California
Akesis investigator site 16
Lawrenceville, New Jersey
Akesis Investigator site 15
Metairie, Louisiana
Akesis investigator site 14
North Miami, Florida
Akesis investigator site 13
Philadelphia, Pennsylvania
Akesis investigator site 11
Port Jefferson, New York
Akesis Investigator site 9
Roswell, Georgia
Akesis investigator site 6
San Diego, California
Akesis investigator site 17
Sanford, Florida, 32771
Akesis investigator site 8
Sunrise, Florida
Akesis Investigator site 10
West Palm Beach, Florida
Dominican Republic2 sites
Akesis investigator site 3
Santo Domingo, Republica Dominicana
Akesis investigator site 4
Santo Domingo, Republica Dominicana
About this study
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.
Read the 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
- Being tested
- clindamycin phosphate vaginal cream 2%, placebo
- Medical subject headings
- Vaginosis, Bacterial, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clindamycin phosphate vaginal cream 2%Drug
placeboOther
vehicle used as placebo
| Study group | Role | What they receive |
|---|---|---|
| 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.) Receives: 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™) Receives: 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.) Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 22 to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startJan 2014
- Primary completionOct 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BACTERIAL VAGINOSISStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 604 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actavis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Watson Laboratories, Inc.
- Responsible party
- Sponsor
- Investigators
- nageshwar r thudi, Ph.D., CCRP, Study director, Actavis Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210689
- Sponsor's protocol ID
- 13-1052
- Status last verified
- Jan 2020
- First submitted
- 4 Aug 2014
- Last updated
- 28 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02210689
- Acronym / sponsor ID
- 13-1052
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 604 participants (actual)
- Lead sponsor
- Actavis Inc.Industry (pharma, biotech, devices)
- Collaborators
- Watson Laboratories, Inc.
- Study start
- Jan 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 7 Aug 2014 (estimated)
- Results
- Posted 26 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| test product | Experimental | Drug: clindamycin phosphate vaginal cream 2%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 | Active comparator | Drug: clindamycin phosphate vaginal cream 2%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 | Placebo comparator | Other: placeboOne single-dose, pre-filled disposable applicator delivering approximately 5 g of cream containing vehicle of the test product (Watson Laboratories, Inc.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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:
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clindamycin phosphate vaginal cream 2% | Drug | reference product, test product |
| placebovehicle used as placebo | Other | placebo |
Primary outcome
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).
Time frame: 22 to 30 days
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
nageshwar r thudi, Ph.D., CCRP study director
Actavis Inc.
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing clindamycin phosphate vaginal cream 2% in people with BACTERIAL VAGINOSIS and Signs and Symptoms to be Evaluated and Recorded Include, run by Actavis Inc. at 18 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Dominican Republic, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: 22 to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.