TOL-463 Phase 2 Study for Vaginitis (NCT02866227) | Clinical Trial Compass
CompletedPhase 2
TOL-463 Phase 2 Study for Vaginitis
United States106 participantsStarted 2016-07-15
Plain-language summary
This is a Phase II study designed to assess the safety and efficacy of an investigational product, TOL-463, to treat vaginitis.
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Diagnosis of bacterial vaginosis based on the presence of all four Amsel criteria.\*
. 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.
. Participant is willing and able to provide written informed consent.
. 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.\*
. 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.
Exclusion criteria
. A diagnosis of vaginitis other than BV or VVC or another vaginal or vulvar condition\* that might confuse interpretation of response to study product.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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.
Timeframe: 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.
Timeframe: Day 9-12
3
Proportion of participants with clinical cure at Visit 2 among participants with BV at baseline who received TOL-463 Gel.
Timeframe: Day 9-12
4
Proportion of participants with clinical cure at Visit 2 among participants with BV at baseline who received TOL-463 Insert.
Timeframe: Day 9-12
5
Proportion of participants with clinical cure at Visit 2 among participants with VVC at baseline who received TOL-463 Gel.
Timeframe: Day 9-12
6
Proportion of participants with clinical cure at Visit 2 among participants with VVC at baseline who received TOL-463 Insert.
. 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.
. 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.