Bacterial VaginosisPhase 3NCT01621399
Safety and Efficacy Study to Treat Bacterial Vaginosis
A Phase 3 study testing Product 55394 in people with Bacterial Vaginosis, run by Medicis Global Service Corporation at 37 sites in United States.
Trial summary
The purpose of this study is to determine if product 55394 is safe and efficacious for the treatment of bacterial vaginosis. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- Product 55394
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 651 participants
- Where
- 37 sitesUnited States
- Study dates
- May 2012to Dec 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Have a clinical diagnosis of bacterial vaginosis as determined by the investigator.
- Other items as identified in the protocol.
Who cannot join
- Have a known or suspected other infectious cause of vulvovaginitis.
- Other items as identified in the protocol.
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
United States37 sites
Study site
Atlanta, Georgia
Study site
Augusta, Georgia
Study site
Birmingham, Alabama
Study site
Boyton Beach, Florida
Study site
Chicago, Illinois
Study site
Clearwater, Florida
Study site
Columbia, South Carolina
Study site
Columbus, Ohio
Study site
Corpus Christi, Texas
Study site
Denver, Colorado
Study site
Detroit, Michigan
Study site
Falls River, Massachusetts
Study site
Groton, Connecticut
Study site
Houston, Texas
Study site
Jackson, Tennessee
Study site
Jenkintown, Pennsylvania
Study site
La Mesa, California
Study site
Lawrenceville, New Jersey
Study site
Lincoln, Nebraska
Study site
Los Angeles, California
Study site
Marrero, Louisiana
Study site
Miami, Florida
Study site
Neptune City, New Jersey
Study site
North Miami, Florida
Study site
Philadelphia, Pennsylvania
Study site
Phoenix, Arizona
Study site
Plainsboro, New Jersey
Study site
Roswell, Georgia
Study site
Saginaw, Michigan
Study site
San Diego, California
Study site
Schertz, Texas
Study site
Seattle, Washington
Study site
Sunrise, Florida
Study site
Tacoma, Washington
Study site
Torrance, California
Study site
Virginia Beach, Virginia
Study site
Williston, Vermont
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Vehicle-controlled Study to Evaluate the Safety and Efficacy of Product 55394 in the Treatment of Bacterial Vaginosis
The purpose of this study is to determine if product 55394 is safe and efficacious for the treatment of bacterial vaginosis.
- Conditions
- Bacterial Vaginosis
- Being tested
- Product 55394, Placebo Vehicle (non-treatment)
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Product 55394Drug
Product 55394 vaginal gel in a prefilled applicator.
Placebo Vehicle (non-treatment)Drug
The vehicle vaginal gel in an applicator (placebo).
| Study group | Role | What they receive |
|---|---|---|
| Vehicle | Placebo comparator | Treatment with the vehicle (placebo) Receives: Drug: Placebo Vehicle (non-treatment) |
| Product 55394 | Experimental | Treatment with product 55394 Receives: Drug: Product 55394 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Cure
The proportion of subjects with a clinical cure at the Day 21 visit, as assessed by the investigator.
Measured: Day 21
Secondary outcomes (1)
Therapeutic Cure
The proportion of subjects with a therapeutic cure at the Day 21 visit. Therapeutic cure is defined as both a clinical cure and bacteriological cure as assessed by the investigator and the central laboratory, respectively.
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionOct 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 651 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicis Global Service Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ron Staugaard, Study director, Medicis Pharmaceutical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01621399
- Sponsor's protocol ID
- MP-1601-01
- Status last verified
- Aug 2013
- First submitted
- 14 Jun 2012
- Last updated
- 21 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-blind, Vehicle-controlled Study to Evaluate the Safety and Efficacy of Product 55394 in the Treatment of Bacterial Vaginosis
- ClinicalTrials.gov ID
- NCT01621399
- Acronym / sponsor ID
- MP-1601-01
- Conditions
- Bacterial Vaginosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 651 participants (actual)
- Lead sponsor
- Medicis Global Service CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 18 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if product 55394 is safe and efficacious for the treatment of bacterial vaginosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vehicle | Placebo comparator | Drug: Placebo Vehicle (non-treatment)Treatment with the vehicle (placebo) |
| Product 55394 | Experimental | Drug: Product 55394Treatment with product 55394 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have a clinical diagnosis of bacterial vaginosis as determined by the investigator.
- Other items as identified in the protocol.
Key exclusion criteria (2 listed)
- Have a known or suspected other infectious cause of vulvovaginitis.
- Other items as identified in the protocol.
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 |
|---|---|---|
| Product 55394Product 55394 vaginal gel in a prefilled applicator. | Drug | Product 55394 |
| Placebo Vehicle (non-treatment)The vehicle vaginal gel in an applicator (placebo). | Drug | Vehicle |
Primary outcome
Clinical Cure
Time frame: Day 21
The proportion of subjects with a clinical cure at the Day 21 visit, as assessed by the investigator.
1 secondary outcome
Therapeutic Cure
Time frame: Day 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2013.
Related trials for Bacterial Vaginosis
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 2
WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
RecruitingPhase 1
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
Randomized, Open-label
Not yet recruitingPhase 1
A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
Bacterial Vaginosis
Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Bacterial Vaginoses
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.
Ron Staugaard study director
Medicis Pharmaceutical
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Product 55394 in people with Bacterial Vaginosis, run by Medicis Global Service Corporation at 37 sites in United States.
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 2 inclusion and 2 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 21 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical Cure (time frame: Day 21). 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 21 Aug 2013.