BridgeMD
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
EU CTIS ID: 2023-504727-32-00
What this study is testing
To assess the efficacy of albaconazole (XX, YY or ZZ) compared to placebo with respect to clinical cure in subjects with acute Candida vulvovaginitis.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 ≤ 4.4 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. In the case of adolescents (post-menarche women younger than 18 years of age at enrolment), assent by the subject must be given as well as consent from parent/legal representative, according to local legislation.
- 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.
You likely can't join if
- 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.
See the full eligibility criteria
Who can join
- 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 ≤ 4.4 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. In the case of adolescents (post-menarche women younger than 18 years of age at enrolment), assent by the subject must be given as well as consent from parent/legal representative, according to local legislation.
- 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.
What rules you out
- 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.
The study team makes the final eligibility decision.
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, 0-17 years, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.