Vaginal InfectionPhase 1NCT01812889
Evaluation of Intravaginal Gel and Ovule Formulations of TOL-463
A Phase 1 study testing TOL-463 Vaginal ovule and TOL-463 Vaginal gel in people with Vaginal Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Infection
- What is being tested?
- TOL-463 Vaginal ovule and TOL-463 Vaginal gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to May 2014
- Phase
- Phase 1
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
- Subjects must be healthy as determined by medical history, physical examination, vital signs, pelvic examination and laboratory evaluations (hematology, clinical chemistry and urinalysis tests) within study-defined ranges at Screening.
- Subjects must be without current symptomatic or asymptomatic bacterial vaginosis, candida vulvovaginitis or any other form of vaginitis by clinical and microbiologic testing.
- Subjects must be willing to abstain from sexual intercourse for 24 hours prior to each site visit.
- For Part 2 Only
- Subjects with vaginitis must be otherwise healthy based on medical history, physical examination, vital signs, pelvic examination and laboratory evaluations (hematology, clinical chemistry and urinalysis tests) within study-defined ranges at Screening.
- Subjects with vaginitis must be willing to abstain from sexual intercourse 24 hours prior to the first dose of study medication and throughout the last visit of the study.
Who cannot join
- A history of clinically significant acute illness (resolved within 4 weeks of screening) or any other condition which, in the opinion of the Site Principal Investigator (PI), would jeopardize the safety of the subject or impact the validity of the study results.
- Subjects with intrauterine devices.
- Subjects with renal dysfunction (serum creatinine >/= 1.2 mg/dL).
- Subjects with underlying metabolic or endocrine dysfunction, such as diabetes mellitus, Cushing's disease, Addison's disease, or hypo- or hyperthyroidism.
- Subjects who test positive for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody.
- Subjects who have diseases known to cause immunodeficiency, e.g., AIDS, advanced malignancy, anemia or severe vitamin deficiency.
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- Subjects who test positive for Trichomonas vaginalis, Neisseria gonorrhea, or Chlamydia trachomatis at screening.
- Subjects with active genital lesions at screening, including syphilitic chancre, herpetic lesions, or genital warts (HPV).
- Subjects who have had major surgery within 4 weeks of screening.
- Subjects with an uncontrolled active illness (e.g., active infection) or fever (oral temperature >/=100 degrees F or >/= 37.7 degrees C) at screening.
- Subjects with a known sensitivity to any ingredient in TOL-463 vaginal gel or ovule.
- With the exception of oral contraceptives, use of a prescription medication, notably antimicrobial agents, corticosteroids or other immuno-suppressants, within 14 days prior to Day 1 of study treatment, unless in the opinion of the PI, the substance would not likely impact the conduct or results of this study.
- Subjects with any current unstable medical condition(s) requiring prescription medication(s) that would preclude accurate evaluation of subjects or otherwise impact the conduct or results of the study.
- Subjects who have received an investigational drug in a clinical trial within 30 days prior to screening.
- Women who are pregnant or breast feeding. Subject has a positive history for alcohol abuse or dependence and/or a positive urine screen test for alcohol and drugs of abuse [amphetamines, barbiturates, benzodiazepines, cocaine metabolites, marijuana, opiates, phencyclidine (PCP)] at screening or at any check-in prior to receiving study drug.
- Subjects who have donated blood within the past 30 days prior to Day 1 of treatment with study drugs.
Trial locations and contacts
1 site in 1 country.
United States1 site
Quintiles Phase I Services - Overland Park
Overland Park, Kansas, 66211-1553
About this study
Official title: A Two Part Randomized, Open-Label Phase I Safety and Pharmacokinetic Evaluation of Gel and Ovule Formulations of TOL-463 (Intravaginal Therapy) in 18-45 Year Old Healthy Female Subjects and Women With Vaginitis
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).
Read the detailed description
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).
- Conditions
- Vaginal Infection
- Being tested
- TOL-463 Vaginal ovule, TOL-463 Vaginal gel
- Keywords
- bacterial vaginosis, vulvovaginal candidiasis, TOL-463, intravaginal therapy, vaginitis, women, cross-over
- Medical subject headings
- Vaginitis, Vaginosis, Bacterial, Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOL-463 Vaginal ovuleDrug
TOL-463 Vaginal Ovule
TOL-463 Vaginal gelDrug
TOL-463 Vaginal Gel
| Study group | Role | What they receive |
|---|---|---|
| Part 2 | Active comparator | 10 women diagnosed with BV, 10 diagnosed with VVC will be randomized to receive either TOL-463 gel or TOL-463 ovules administered intravaginally once daily for 7 consecutive days Receives: Drug: TOL-463 Vaginal ovule; Drug: TOL-463 Vaginal gel |
| Part 1 | Active comparator | 20 Healthy women randomized, two-way crossover design will receive a single dose of TOL-463 gel and ovule intravaginally, separated by a minimum of 7 day washout period between administrations Receives: Drug: TOL-463 Vaginal ovule; Drug: TOL-463 Vaginal gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Up to Day 16
Secondary outcomes (1)
Standard PK parameters (half-life, Cmax, Tmax and AUC), will be assessed following single-dose administration of TOL-463 gel and ovule in healthy subjects and after single- and multiple-dose administration of TOL-463 gel or ovules in women with BV or VVC
Measured: Once daily for 1 or 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionJan 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal InfectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01812889
- Sponsor's protocol ID
- 11-0077
- Other IDs
- HHSN272200800024C, TOL-463
- Status last verified
- May 2014
- First submitted
- 14 Mar 2013
- Last updated
- 16 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two Part Randomized, Open-Label Phase I Safety and Pharmacokinetic Evaluation of Gel and Ovule Formulations of TOL-463 (Intravaginal Therapy) in 18-45 Year Old Healthy Female Subjects and Women With Vaginitis
- ClinicalTrials.gov ID
- NCT01812889
- Acronym / sponsor ID
- 11-0077
- Conditions
- Vaginal Infection
- Keywords
- bacterial vaginosis, vulvovaginal candidiasis, TOL-463, intravaginal therapy, vaginitis, women, cross-over
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Apr 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 18 Mar 2013 (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 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).
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 2 | Active comparator | Drug: TOL-463 Vaginal ovule, Drug: TOL-463 Vaginal gel10 women diagnosed with BV, 10 diagnosed with VVC will be randomized to receive either TOL-463 gel or TOL-463 ovules administered intravaginally once daily for 7 consecutive days |
| Part 1 | Active comparator | Drug: TOL-463 Vaginal ovule, Drug: TOL-463 Vaginal gel20 Healthy women randomized, two-way crossover design will receive a single dose of TOL-463 gel and ovule intravaginally, separated by a minimum of 7 day washout period between administrations |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- 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).
- 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.
Key exclusion criteria (16 listed)
- A history of clinically significant acute illness (resolved within 4 weeks of screening) or any other condition which, in the opinion of the Site Principal Investigator (PI), would jeopardize the safety of the subject or impact the validity of the study results.
- Subjects with intrauterine devices.
- Subjects with renal dysfunction (serum creatinine >/= 1.2 mg/dL).
- Subjects with underlying metabolic or endocrine dysfunction, such as diabetes mellitus, Cushing's disease, Addison's disease, or hypo- or hyperthyroidism.
- Subjects who test positive for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody.
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 |
|---|---|---|
| TOL-463 Vaginal ovuleTOL-463 Vaginal Ovule | Drug | Part 1, Part 2 |
| TOL-463 Vaginal gelTOL-463 Vaginal Gel | Drug | Part 1, Part 2 |
Primary outcome
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.
Time frame: 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).
Time frame: Up to Day 16
1 secondary outcome
Standard PK parameters (half-life, Cmax, Tmax and AUC), will be assessed following single-dose administration of TOL-463 gel and ovule in healthy subjects and after single- and multiple-dose administration of TOL-463 gel or ovules in women with BV or VVC
Time frame: Once daily for 1 or 7 days
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 16 May 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TOL-463 Vaginal ovule and TOL-463 Vaginal gel in people with Vaginal Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 18 inclusion and 16 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 16 May 2014. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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. (time frame: Following daily dosing for 1 or 7 days). The study lists 2 primary outcomes in all. 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 16 May 2014.