AzTrials
AzTrials

Bacterial VaginosisPhase 2NCT02866227

TOL-463 Phase 2 Study for Vaginitis

A Phase 2 study testing TOL-463 in people with Bacterial Vaginosis and Vulvovaginal Candidiasis, run by Toltec Pharmaceuticals, LLC at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a Phase II study designed to assess the safety and efficacy of an investigational product, TOL-463, to treat vaginitis. Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Bacterial Vaginosis, Vulvovaginal Candidiasis
What is being tested?
TOL-463
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
2 sitesUnited States
Study dates
15 Jul 2016to 10 Jun 2017
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
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Participants eligible to participate in this study must meet criteria 1 or 2 or both and all of the remaining inclusion criteria:
  • Diagnosis of bacterial vaginosis based on the presence of all four Amsel criteria.*
  • Homogeneous vaginal discharge (off white, milky or gray, thin), positive KOH whiff test, vaginal secretions pH of > 4.5, clue cells > /= 20 percent of vaginal squamous epithelial cells on saline "wet mount"
  • Diagnosis of VVC based on the presence of pseudohyphae on KOH preparation; must also have at least one sign and one symptom*, each rated based on severity** with minimum composite score of 2.
  • Signs include vulvovaginal edema, erythema, and/or excoriation. Symptoms include vulvovaginal itching, burning, and/or irritation. **Severity will be graded on a scale of 0-3 (absent = 0; mild = 1; moderate = 2; severe = 3).
  • Participant is willing and able to provide written informed consent.
Show all 19Show fewer
  • Participant is 18-50 years of age.
  • Participant is in general good health based on medical history, physical examination, vital signs, and pelvic examination.
  • Any Pap test performed in the prior 3 years must be normal or ASCUS HPV negative.*
  • Consistent with current Pap screening guidelines, a Pap smear must be performed at Visit 1 for any participant who meets the following criteria and cannot provide documentation (which can include self-report) of a normal or ASCUS HPV negative Pap test within the prior 3 years: is 21 years of age or older and (a) has not had a hysterectomy or (b) has had a hysterectomy and has a history of cervical intraepithelial neoplasia grade 2+ (CIN2+) in the past 20 years. If a Pap smear is conducted at Visit 1, the results are not required prior to enrollment.
  • Participant must have a negative urine pregnancy test at study enrollment.
  • Participant must agree to abstain from sexual intercourse during the seven days of study medication use.
  • Participant must be of non-childbearing potential* or must be using highly effective birth control** to avoid becoming pregnant from the time period noted below prior to and through the end of study treatment.
  • Non-childbearing potential is defined as being post-menopausal for at least 1 year, status after bilateral tubal ligation for at least 1 year, or status after bilateral oophorectomy or status after hysterectomy.
  • Acceptable methods of birth control include use of hormonal contraceptives from 30 days prior to study drug dosing or having been abstinent from vaginal sexual intercourse from 21 days prior to study drug dosing and agreeing to abstain from oral, anal, and vaginal sexual intercourse during study drug dosing and, if sexually active, use of non-lubricated condoms (in addition to hormonal contraception) for the remainder of the study through the final visit (V3). Intravaginal or intrauterine contraceptives and contraceptive devices are not acceptable forms of birth control for this study.
  • Participant is willing and able to cooperate to the extent and degree required by this protocol at the discretion of the investigator.
  • Participant is willing to refrain from douching and applying any intravaginal products/medications* throughout the course of the trial.
  • e.g., antifungal preparations, deodorant sprays, spermicides, contraceptive creams, gels, foams, sponges
  • Participant is willing to refrain from using tampons and diaphragms for the seven days of the study product use.

Who cannot join

  • A diagnosis of vaginitis other than BV or VVC or another vaginal or vulvar condition* that might confuse interpretation of response to study product.
  • Examples of such conditions include erosive lichen planus, desquamative interstitial vaginitis, or contact dermatitis involving the vulvar epithelium.
  • Presence of T. vaginalis on wet mount or evidence of other infectious cause of cervicitis or vaginitis on physical examination.
  • Active genital lesions, including ulcers, vesicles consistent with herpes, or warts.
  • Use of metronidazole or other 5-nitro-imidazole derivative or clindamycin or an antifungal agent (intravaginal or systemic) for the treatment of any condition within 14 days of start of study.
  • Planned ongoing immunosuppressive therapy or systemic antibiotic treatment during the course of the study.
Show all 13Show fewer
  • Use of any investigational drug within 30 days prior to screening.
  • History of hypersensitivity to any ingredient in the formulations.
  • Women with cervical intraepithelial neoplasia (CIN) or cervical carcinoma.
  • Currently breastfeeding.
  • Menstruating at the time of diagnosis.*
  • Women menstruating at the time of diagnosis may be rescreened at a later time.
  • Any other condition that, in the opinion of the investigator, would interfere with participation in the study.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Alabama at Birmingham School of Medicine- Infectious Disease

    Birmingham, Alabama, 35294

  • University of Washington - Harborview Medical Center - Center for AIDS and STD

    Seattle, Washington, 98104-2499

Other trials in United States

About this study

Official title: A Randomized Single Blind Safety and Efficacy Study of TOL-463 Vaginal Gel or Insert in the Treatment of Vaginitis (BV and/or VVC)

This is a Phase II study designed to assess the safety and efficacy of an investigational product, TOL-463, to treat vaginitis.

Read the detailed description

This is a Phase II randomized single blind safety and efficacy study of TOL-463, administered to female adults to treat vaginitis. Participants will be randomly assigned (1:1) to dose TOL-463 Gel or TOL-463 Insert. Study medication will be administered vaginally, once nightly for seven days. The duration of the study for each participant will be approximately 21-30 days.

Being tested
TOL-463
Keywords
Bacterial, Candidiasis, Gel, Insert, TOL-463, Vaginal, Vaginitis, Vaginoses, Vulvovaginal
Medical subject headings
Vaginosis, Bacterial, Candidiasis, Vulvovaginal, Candidiasis, Vaginitis

What participants receive

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

  • TOL-463Drug

    TOL-463 vaginal gel

  • TOL-463Drug

    TOL-463 vaginal insert

Study groups in NCT02866227
Study groupRoleWhat they receive
BV and/or VVC infection - Gel TreatmentExperimentalRandomized 1:1 to gel nightly for 7 days. N = 40
Receives: Drug: TOL-463
BV and/or VVC infection - Vaginal Insert TreatmentExperimentalRandomized 1:1 to insert nightly for 7 days. N = 40
Receives: Drug: TOL-463

What is being measured

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

  1. Proportion of participants w/ clinical cure (score 0 at TOC for any sign/symptom scored 1-2 at baseline or score 0-1 at TOC for any sign/symptom scored 3 at baseline w/o further treatment needed) at Visit 2 among participants w/ VVC at baseline overall.

    Measured: Day 9-12

  2. Proportion of participants with clinical cure (defined as absence of: positive KOH whiff test, homogeneous discharge characteristic of BV, clue cells > /= 20% of vaginal squamous epithelial cells) at Visit2 among participants with BV at baseline overall.

    Measured: Day 9-12

  3. Proportion of participants with clinical cure at Visit 2 among participants with BV at baseline who received TOL-463 Gel.

    Measured: Day 9-12

  4. Proportion of participants with clinical cure at Visit 2 among participants with BV at baseline who received TOL-463 Insert.

    Measured: Day 9-12

  5. Proportion of participants with clinical cure at Visit 2 among participants with VVC at baseline who received TOL-463 Gel.

    Measured: Day 9-12

  6. Proportion of participants with clinical cure at Visit 2 among participants with VVC at baseline who received TOL-463 Insert.

    Measured: Day 9-12

Secondary outcomes (13)

  1. Among participants with concomitant BV and VVC infections at baseline, the proportion of participants meeting BV clinical cure at Visit 2.

    Measured: Day 9-12

  2. Among participants with concomitant BV and VVC infections at baseline, the proportion of participants meeting VVC clinical cure at Visit 2.

    Measured: Day 9-12

  3. The median time (time defined as earliest time point of reported symptom resolution) to symptom relief (at least one day free of all symptoms) as assessed by the participant.

    Measured: Day 1-7

  4. The occurrence of adverse events considered product-related following initiation of study treatment and through the final study visit.

    Measured: Day 1-30

  5. The occurrence of secondary VVC following initiation of study treatment and through the final study visit in participants with BV at baseline.

    Measured: Day 1-30

  6. The proportion of participants experiencing symptom relief (at least one day free of all symptoms) as assessed by the participant.

    Measured: Day 1-7

  7. The proportion of participants who need additional treatment per physician opinion following initiation of study treatment and through the final study visit.

    Measured: Day 1-30

  8. The proportion of participants with clinical cure at Visit 3 among participants with BV at baseline.

    Measured: Day 21-30

  9. The proportion of participants with clinical cure at Visit 3 among participants with VVC at baseline.

    Measured: Day 21-30

  10. The proportion of participants with microbiologic cure (Nugent score of 0-3) at Visits 2 and 3 among participants with BV at baseline.

    Measured: Day 9-12, Day 21-30

  11. The proportion of participants with mycological cure at Visits 2 and 3 among participants with VVC at baseline.

    Measured: Day 9-12, Day 21-30

  12. The proportion of participants with therapeutic cure at Visits 2 and 3 among participants with BV at baseline.

    Measured: Day 9-12, Day 21-30

  13. The proportion of participants with therapeutic cure at Visits 2 and 3 among participants with VVC at baseline.

    Measured: Day 9-12, Day 21-30

Timeline

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

  1. First posted15 Aug 2016 (estimated)
  2. Study start15 Jul 2016
  3. Primary completion10 Jun 2017
  4. Study completion10 Jun 2017

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
Single blind
Who is masked
Outcomes assessor
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02866227
Sponsor's protocol ID
15-0039
Other IDs
HHSN272201300012I
Status last verified
Mar 2018
First submitted
28 Jul 2016
Last updated
9 Mar 2018
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Marrazzo JM, Dombrowski JC, Wierzbicki MR, Perlowski C, Pontius A, Dithmer D, Schwebke J. Safety and Efficacy of a Novel Vaginal Anti-infective, TOL-463, in the Treatment of Bacterial Vaginosis and Vulvovaginal Candidiasis: A Randomized, Single-blind, Phase 2, Controlled Trial. Clin Infect Dis. 2019 Feb 15;68(5):803-809. doi: 10.1093/cid/ciy554.

    PubMed 30184181

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TOL-463 in people with Bacterial Vaginosis and Vulvovaginal Candidiasis, run by Toltec Pharmaceuticals, LLC at 2 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 19 inclusion and 13 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 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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. 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 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?

Proportion of participants w/ clinical cure (score 0 at TOC for any sign/symptom scored 1-2 at baseline or score 0-1 at TOC for any sign/symptom scored 3 at baseline w/o further treatment needed) at Visit 2 among participants w/ VVC at baseline overall. (time frame: Day 9-12). The study lists 6 primary outcomes in all. 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 NCT02866227, which also lists 1 linked publication.

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 9 Mar 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in