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BACTERIAL VAGINOSISPhase 2VARIANTNCT02376972

Efficacy and Safety Study of Rifaximin Vaginal Tablets in Bacterial Vaginosis

A Phase 2 study testing RIFAXIMIN VAGINAL TABLET 25 MG, RIFAXIMIN VAGINAL TABLET 100 MG and METROGEL VAGINAL in people with BACTERIAL VAGINOSIS, run by Alfasigma S.p.A. at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

THE STUDY HAS BEEN DESIGNED TO COMPARE THE EFFICACY OF TWO DOSES (25 MG AND 100 MG) OF RIFAXIMIN VAGINAL TABLETS VERSUS PLACEBO IN SUBJECTS WITH BACTERIAL VAGINOSIS Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
BACTERIAL VAGINOSIS
What is being tested?
RIFAXIMIN VAGINAL TABLET 25 MG, RIFAXIMIN VAGINAL TABLET 100 MG and METROGEL VAGINAL
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
392 participants
Where
1 siteUnited States
Study dates
Apr 2015to Feb 2016
Phase
Phase 2
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 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Clinical diagnosis of bacterial vaginosis with Amsel's criteria (4 out of 4 fulfilled criteria):
  • Off white (milky or gray), thin, homogeneous, adherent vaginal discharge
  • pH >4.5
  • Positive "whiff test"
  • Presence of clue cells ≥20%
  • Bacteriological diagnosis of bacterial vaginosis with Gram stain Nugent score ≥ 4 (patients may be enrolled/randomized without this result)
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  • Post-menarchal, pre-menopausal female patient
  • Non-pregnant (negative urine pregnancy test at Entry Visit/V1) nor breast-feeding patient
  • Patient aged between 18 50 years, inclusively
  • Patient who is willing to be asked questions about personal medical health and sexual history
  • Patient capable of and willing to conform to the study protocol
  • Patient who have been thoroughly informed of the aim of the study and the study procedures and who provided signed and dated written informed consent form
  • Patient who agrees to abstain from intercourse during the 5 day treatment period
  • Patient who agrees also to abstain from intercourse 3 days before the scheduled visits of follow-up
  • Patient who agrees to abstain from the use of any other intravaginal product (i.e., douching, feminine deodorants sprays, tampons, spermicides, gels, foams, vaginal birth control ring and diaphragms) during the entire study period
  • Patient who agrees to use an adequate method of birth control for the duration of the study to avoid pregnancy. Acceptable methods include a history of bilateral tubal ligation, male partner with a vasectomy, a hormonal contraceptive [oral, patch, injectable or implantable (excluding intrauterine implantable devices [IUD], intrauterine system [IUS] and vaginal rings), or abstinence
  • Patient who agrees to abstain from alcohol ingestion during the 5-day treatment period and for 1 day afterward

Who cannot join

  • Virginity
  • Patient with other infectious causes of vulvovaginitis (e.g., candidiasis, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, active Herpes simplex lesions, or Human Papilloma Virus lesions); patients may be enrolled/randomized without these results)
  • Other vulvovaginal or cervical conditions, abnormalities or disorders confounding the interpretation of clinical response (including total hysterectomy)
  • Symptoms suggestive of pelvic inflammatory disease
  • Patient with intra uterine device (IUD), intrauterine system (IUS), or vaginal ring as contraceptive method
  • Patient with severe hepatic insufficiency (Child C)
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  • Patient with severe cardiac insufficiency (NYHA - New York Heart Association classes 3 - 4)
  • Patient who will be being evaluated, including colposcopy and cervical biopsies, or being treated during the study period, for abnormal Pap test or cervical carcinoma. To note that if the Pap test will be performed at baseline, the result will be known after the randomization visit: patients may be enrolled without this result
  • Any condition or circumstance that would prevent completion of the study or interfere with analysis of study results, including a history of drug or alcohol abuse, mental illness or non-compliance with treatments or visits, immunological (including HIV infection), hematological or neoplastic disease (including all cervical neoplastic diseases)
  • Cervical cryotherapy, loop electrosurgical excision (LEEP), cervical laser, or any other ablative or excisional cervical procedures within the last 3 months
  • Vaginal laser within the last 3 months
  • Patient with clinically relevant pathological laboratory values
  • Known hypersensitivity to rifaximin
  • Known hypersensitivity to excipients present in rifaximin, placebo or metronidazole formulations
  • Known hypersensitivity to metronidazole, either orally or topically administered, or any forms of parabens
  • Concurrent anticoagulant therapy with coumadin or warfarin
  • Menstruating or anticipated menstruation/withdrawal bleed at Entry Visit/V1 and during the drug administration
  • Patient who received antifungal or antimicrobial therapy (systemic or intravaginal) within 14 days of randomization
  • Patient who have participated in another clinical trial or have taken an investigational drug within the last 4 weeks prior screening
  • Patient who has taken disulfuram within the last 14 days
  • Withdrawal of informed consent
  • Patient previously randomized in this study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • College of Medicine Drexel University

    Philadelphia, Pennsylvania, 191012-1192

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of Rifaximin Vaginal Tablets in the Treatment of Bacterial Vaginosis

THE STUDY HAS BEEN DESIGNED TO COMPARE THE EFFICACY OF TWO DOSES (25 MG AND 100 MG) OF RIFAXIMIN VAGINAL TABLETS VERSUS PLACEBO IN SUBJECTS WITH BACTERIAL VAGINOSIS

Read the detailed description

THIS IS A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY PLANNING TO ENROL 626 SUBJECTS AFFECTED BY BACTERIAL VAGINOSIS.

PRIMARY ENDPOINT:

TO COMPARE THE EFFICACY OF TWO DOSES (25 MG AND 100 MG) OF RIFAXIMIN VAGINAL TABLETS VERSUS PLACEBO IN SUBJECTS WITH BACTERIAL VAGINOSIS

SECONDARY ENDPOINT:

TO COMPARE THE EFFICACY OF TWO DOSES (25 MG AND 100 MG) OF RIFAXIMIN VAGINAL TABLETS VERSUS METROGEL VAGINAL IN SUBJECTS WITH BACTERIAL VAGINOSIS.

Being tested
RIFAXIMIN VAGINAL TABLET 25 MG, RIFAXIMIN VAGINAL TABLET 100 MG, PLACEBO VAGINAL TABLET, METROGEL VAGINAL
Medical subject headings
Vaginosis, Bacterial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RIFAXIMIN VAGINAL TABLET 25 MGDrug

    RIFAXIMIN VAGINAL TABLET 25 MG O.D./5 DAYS INTRAVAGINALLY

  • RIFAXIMIN VAGINAL TABLET 100 MGDrug

    RIFAXIMIN VAGINAL TABLET 100 MG O.D./5 DAYS INTRAVAGINALLY

  • PLACEBO VAGINAL TABLETDrug

    PLACEBO VAGINAL TABLET O.D./5 DAYS INTRAVAGINALLY

  • METROGEL VAGINALDrug

    METROGEL VAGINAL O.D./5 DAYS INTRAVAGINALLY

Study groups in NCT02376972
Study groupRoleWhat they receive
RIFAXIMIN VAGINAL TABLET 25 MGExperimentalRIFAXIMIN VAGINAL TABLET 25 MG ADMINISTERED ONCE A DAY FOR 5 DAYS
Receives: Drug: RIFAXIMIN VAGINAL TABLET 25 MG
RIFAXIMIN VAGINAL TABLET 100 MGExperimentalRIFAXIMIN VAGINAL TABLET 100 MG ADMINISTERED ONCE A DAY FOR 5 DAYS
Receives: Drug: RIFAXIMIN VAGINAL TABLET 100 MG
PLACEBO VAGINAL TABLETPlacebo comparatorPLACEBO VAGINAL TABLET ADMINISTERED ONCE A DAY FOR 5 DAYS
Receives: Drug: PLACEBO VAGINAL TABLET
METROGEL VAGINALActive comparatorMETROGEL VAGINAL ADMINISTERED ONCE A DAY FOR 5 DAYS
Receives: Drug: METROGEL VAGINAL

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CLINICAL CURE OF BACTERIAL VAGINOSIS

    RESOLUTION OF 3 OUT OF 4 AMSEL'S CRITERIA, I.E. NORMAL PHYSIOLOGICAL DISCHARGE, NEGATIVE "WHIFF TEST", CLUE CELLS >20%

    Measured: Day 22-30

Secondary outcomes (8)

  1. BACTERIOLOGICAL CURE OF BACTERIAL VAGINOSIS

    GRAM STAIN NUGENT SCORE <4

    Measured: Day 22-30

  2. THERAPEUTIC CURE OF BACTERIAL VAGINOSIS

    AMSEL'S CRITERIA AND GRAM STAIN NUGENT (RESOLUTION OF 3 OUT OF 4 AMSEL'S CRITERIA AND NUGENT SCORE <4)

    Measured: Day 22-30

  3. MAINTENANCE OF CLINICAL CURE OF BACTERIAL VAGINOSIS

    AMSEL'S CRITERIA (RESOLUTION OF 3 OUT OF 4 AMSEL'S CRITERIA)

    Measured: Day 61-70

  4. MAINTENANCE OF BACTERIOLOGICAL CURE OF BACTERIAL VAGINOSIS

    NUGENT SCORE <4

    Measured: Day 61-70

  5. MAINTENANCE OF THERAPEUTIC CURE OF BACTERIAL VAGINOSIS

    AMSEL'S CRITERIA AND NUGENT SCORE (MAINTENANCE OF RESOLUTION OF 3 OUT OF 4 AMSEL'S CRITERIA AND NUGENT SCORE <4)

    Measured: 60-69 DAYS AFTER THE FIRST DAY OF TREATMENT

  6. NUMBER, INTENSITY AND TYPE OF ADVERSE EVENTS

    The incidence of adverse events to be summarized by body system and MedDRA preferred term.

    Measured: Up to Day 70

  7. LOCAL OBJECTIVE TOLERABILITY

    Vaginal mucosa status in terms of erythema (score 0 to 3), edema (score 0 to 3), pethechial hemorrhages (absence/presence), ulcers (absence/presence)

    Measured: Day 22-30

  8. LOCAL SUBJECTIVE TOLERABILITY

    Grade (from 0 to 4) of vaginal itching, pain and burning

    Measured: Day 1 to Day 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

Why it stopped: According to the Recommendation of the Indipendent Data Monitoring Committee

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
392 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02376972
Sponsor's protocol ID
RFX-VAG/003/2012
Acronym
VARIANT
Status last verified
Oct 2016
First submitted
19 Feb 2015
Last updated
10 Oct 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RIFAXIMIN VAGINAL TABLET 25 MG, RIFAXIMIN VAGINAL TABLET 100 MG and METROGEL VAGINAL in people with BACTERIAL VAGINOSIS, run by Alfasigma S.p.A. at 1 site 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 17 inclusion and 22 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: stopped early, as of the sponsor's last update on 10 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was stopped early (reason given: According to the Recommendation of the Indipendent Data Monitoring Committee). Results are not available in the source record.

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 OF BACTERIAL VAGINOSIS (time frame: Day 22-30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02376972.

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 10 Oct 2016.

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