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 range18 Years – 50 Years

SexFEMALE

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.
✕. 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.

What they're measuring

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

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

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

Timeframe: Day 9-12

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

Timeframe: Day 9-12

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

Timeframe: Day 9-12

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

Timeframe: Day 9-12

Trial details

NCT IDNCT02866227

SponsorToltec Pharmaceuticals, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-06-10

View on ClinicalTrials.gov More Bacterial Vaginosis trials

Who can participate

Age range18 Years – 50 Years

SexFEMALE

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.
✕. 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.

What they're measuring

Timeframe: Day 9-12

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

Timeframe: Day 9-12

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

Timeframe: Day 9-12

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

Timeframe: Day 9-12

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

Timeframe: Day 9-12