Biweekly Long-term Occidiofungin Study for Suppression of Mycotic Recurrence (NCT07521137) | Clinical Trial Compass
RecruitingPhase 2
Biweekly Long-term Occidiofungin Study for Suppression of Mycotic Recurrence
United States36 participantsStarted 2026-06-04
Plain-language summary
A Randomized, Double-Blind, Placebo-Controlled Phase 2a Study Evaluating the Safety, Tolerability, and Efficacy of OCF001 Intravaginal Gel in Women with Acute Vulvovaginal Candidiasis
Who can participate
Age range
18 Years – 65 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
. Female participants, 18-65 years of age, inclusive.
. Clinical diagnosis of symptomatic VVC or RVVC confirmed at baseline by positive KOH wet mount (i.e., when examined microscopically, vaginal secretions obtained by swab of the vaginal mucosa, placed on a slide and diluted with 10% room temperature potassium hydroxide (KOH) reveal filamentous hyphae/pseudohyphae and/or budding yeast cells).
. Presence of at least one vulvovaginal sign be of at least moderate severity (vulvovaginal erythema, edema, or excoriation) as assessed by the investigator at baseline.
. Presence of at least one vulvovaginal symptom be of at least moderate severity (vulvovaginal itching, burning, or irritation) as reported by the subject at baseline.
. Have a body weight range of ≥45kg/99 lbs to ≤110 kg/242 lbs and a body mass index (BMI) of 18-35 kg/m2.
. Participant is not menstruating at Screening or Day 1 and, based on her menstrual cycle history, is not expected to menstruate during the 7-day intravaginal dosing period.
. In good general health with no clinically relevant abnormalities based on the medical history, vital signs, physical examination, clinical laboratory evaluations (hematology and clinical chemistry), and 12-lead electrocardiogram (ECG) that, in the opinion of the investigator and sponsor, would affect participant's safety.
. Participants who are not surgically sterile must use a medically accepted contraceptive regimen for at least 60 days before the baseline visit and agree to continue such use throughout the duration of the study. Reliable forms of contraception include intrauterine devices in place for at least 3 months, oral hormonal contraceptives, and abstinence. Women of childbearing potential must have a negative urine pregnancy test at screening and Day 1.
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
To evaluate the clinical cure of OCF001 (drug product) to treat acute VVC infection following 7-day intravaginal dose of drug product
Timeframe: 7 days
2
Evaluate the safety and local tolerability of OCF001 (drug product) intravaginal formulation in women with moderate-to-severe acute VVC.
. Clinically significant illness or clinically significant surgery within 4 weeks before the administration of study medication.
. Absence of microbiological confirmation of Candida infection at baseline, defined as: Negative fungal culture for Candida species obtained from a vaginal specimen collected at the Baseline Visit (Day 1), or Failure to obtain an adequate specimen for culture at baseline.
. Allergy to any of the components of OCF001 or similar compounds.
. Women not consenting for sexual abstinence from day 1 to day 10 and on days of drug product administration.
. Pregnant or breastfeeding women excluded
. Positive pregnancy test at screening
. Receipt of an investigational product or device, or participation in a drug research study within a period of 30 days (or 5 half-lives of the drug, whichever is longer) before baseline.