CompletedPhase 1

Evaluation of Intravaginal Gel and Ovule Formulations of TOL-463

United States26 participantsStarted 2013-04

Plain-language summary

The purpose of this study is to determine the safety, local tolerability and pharmacokinetic parameters of TOL-463 intravaginal dosage forms in both healthy, nonpregnant females following single dose administration (Part 1), and in nonpregnant women with vaginitis following multi-dose administration (Part 2).

Who can participate

Age range

18 Years – 45 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: * Adult women of any race between 18 to 45 years of age (inclusive). * Subjects must be able to give voluntary written informed consent before any study related procedure is performed. * Subjects must have a negative serum pregnancy test at Screening and negative urine pregnancy test at all other clinical site visits, as applicable. * Subjects either have no childbearing potential (as defined below) (Note 1) or agree to avoid becoming pregnant from the day of screening through one month after the last study Day using one of the following acceptable methods of birth control (Note 2) in addition to the use of non-lubricated condoms by the male partner (even if vasectomized). * Hormonal contraceptives * Abstinence * Note 1: Non-childbearing potential is defined as being post-menopausal for at least 2 years, status after bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy or status after hysterectomy. * Note 2: Intravaginal or intra-uterine contraceptives and contraceptive devices (IUDs) are not acceptable forms of birth control for this study. * Subjects must agree to refrain from douching or using any intravaginal products (i.e., contraceptive creams, gels, foams, sponges, lubricants, etc.) or IUDs during the study period. * Subjects must agree not to donate blood during the study and up to 14 days after the end of the study. * Subjects willing and able to comply with all study requirements. For Part 1 Only * Subject…

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

The local (vulvovaginal) and systemic safety and tolerability of TOL-463 gel and ovules following a single intravaginal administration in healthy female subjects and following daily dosing for 7 days in women with BV or VVC will be assessed.

Timeframe: Following daily dosing for 1 or 7 days

Adverse events (AEs) will be monitored throughout the course of the study following administration of Investigational Product (IP).

Timeframe: Up to Day 16

Trial details

NCT IDNCT01812889

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2014-01

View on ClinicalTrials.gov More Vaginal Infection trials