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New treatment option for Candidiasis, Vulvovaginal
Official title Biweekly Long-term Occidiofungin Study for Suppression of Mycotic Recurrence
ClinicalTrials.gov ID: NCT07521137
What this study is testing
What is OCF001 Intravaginal Gel?
OCF001 Intravaginal Gel is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for candidiasis, vulvovaginal.
Also referred to as Occidiofungin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65, women only
You may be able to join if
- Participants will be selected for study participation, if they meet the following 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...
- VSS ≥ 5
- KOH or wet prep positive for budding yeast or pseudohyphae
You likely can't join if
- Participants will be excluded from the study, if they meet any of the following criteria:
- Clinically significant cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, gastrointestinal, immunological, dermatological...
- 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...
- 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.
See the full eligibility criteria
Who can join
- Participants will be selected for study participation, if they meet the following 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...
- VSS ≥ 5
- KOH or wet prep positive for budding yeast or pseudohyphae
- Vaginal pH ≤ 4.5
- 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...
- 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...
- Participants must be non-lactating.
- Able to provide written informed consent.
- Able to comply with all protocol-specified assessments and the study visit schedule.
What rules you out
- Participants will be excluded from the study, if they meet any of the following criteria:
- Clinically significant cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, gastrointestinal, immunological, dermatological, neurological, or psychiatric disease.
- 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...
- 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.
- Prescription medications that have not been taken on a stable dosing regimen for at least 30 days.
- Participants must not use any systemic (e.g., oral or injectable) corticosteroid therapy during the study or within 30 days prior to Screening. However, use of topical (no vulvar or vaginal steroids), inhaled...
- Participants must not have received an immunosuppressive medication (e.g. cyclosporine, tacrolimus, methotrexate, etc.), or radiation therapy within 3 months prior to Screening or have a medical condition where it would...
- Use of any intravaginal prescription medication or over-the-counter products within fourteen (14) days before administration of study medication.
- Presence of clinically significant vulvar, vaginal, or cervical lesions (including ulcerations, crusted lesions, painful erosions, or genital warts) suggestive of herpes simplex virus (HSV), human papillomavirus (HPV)...
- Presence of a vaginal discharge consistent with Chlamydia, Trichomonas or bacterial vaginosis. Mixed infections of fungi and parasitic/bacterial origin.
- people with signs, symptoms, or diagnostic findings suggestive of other infectious causes of vulvovaginitis or mixed infection (e.g., bacterial vaginosis, Trichomonas vaginalis, sexually transmitted infections, herpes...
- Clinically significant inguinal lymphadenopathy suggestive of an alternative genital infection or other condition inconsistent with uncomplicated vulvovaginal candidiasis.
- Donation of blood over 500 mL within three months prior to Screening.
- Participants must not be using drugs with a narrow therapeutic index that are metabolized by CYP3A4 and sensitive to induction or inhibition of CYP3A4, CYP2C9 and CYP2C19 during the study.
- Serum alanine aminotransferase (ALT), serum aspartate aminotransferase (AST) \>2.5x the upper limit of normal (ULN) of the reference range.
- Serum creatinine elevation \> 2.0 mg/dL
- Serum total bilirubin \>1.5x the ULN of the reference range, unless the elevation is consistent with Gilbert's Syndrome.
- QTcF interval≥500 ms as corrected by the Fridericia formula or QTcF interval change from baseline \>60 ms, or any clinically significant electrocardiographic abnormality.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.