A double-blind, randomised, dose-finding trial to assess the efficacy, safety and pharmacokinetics of a single dose of albaconazole versus fluconazole and placebo in the treatment of acute Candida vulvovaginitis

Phase 1

Recruiting

• Conditions: Acute vulvovaginal candidiasis; MedDRA version: 20.1Level: PTClassification code: 10047784Term: Vulvovaginal candidiasis Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: CTIS2023-504727-32-00
• Lead Sponsor: Palau Pharma S.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-31
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 500

Inclusion Criteria

Female post-menarche subjects, Diagnosed with acute Candida vulvovaginitis according to the following criteria: a. Two or more of the signs and symptoms of Candida vulvovaginitis (itching, burning, irritation, oedema, redness, or excoriation), with at least one with moderate intensity of vulvovaginal signs and symptoms Grade of symptoms is defined as follows: 0 = absent, 1 = mild, 2 = moderate, 3 = severe. b. Rapid antigen test positive for Candida spp. c. Vaginal pH = 4.5 The diagnosis must be confirmed by a positive Candida spp. culture. Swabs for the culture have to be taken before the intake of IP., Written informed consent/assent given freely after the nature of the trial and disclosure of data has been explained to the subject., For females of childbearing potential only: must use highly effective methods of birth control, e.g. male or female condoms, diaphragms, combined hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner or sexual abstinence (if defined as refraining from heterosexual intercourse during the entire period of risk associated with the trial treatment). For barrier methods as male condoms, female condoms and diaphragms it is recommended to use 2 methods of birth control.

Exclusion Criteria

Pregnant or lactating subjects., Wish of pregnancy within 4 weeks following treatment., Recurrent Candida vulvovaginitis (4 or more confirmed episodes of Candida spp. vaginal infection over the last 12 months prior to Visit 1)., Other active vulvovaginal infection (e.g., bacterial vaginosis, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Herpes simplex or the human papilloma virus) or mixed infections., Subjects with any other vaginal or vulvar condition which may confound the interpretation of the clinical response to treatment., Known contraindications/hypersensitivity to the trial medication, any of the excipients of the trial medication (protocol Section 10.1 and 10.2) or to azole derivatives., Prior treatment with topical vaginal or vulvar antifungal agents within the last 7 days prior to Visit 1 or with systemic antifungal agents within the last 28 days prior to Visit 1.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified