A Phase II, Randomized, Parallel design, Open label, Dose ranging Study to evaluate the efficacy and safety of Furazidin vaginal tablets in women with bacterial vaginosis.
- Conditions
- Bacterial Vaginosis (BV)MedDRA version: 20.1Level: PTClassification code 10004055Term: Bacterial vaginosisSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2021-004579-16-HU
- Lead Sponsor
- Adamed Pharma S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 185
1.A written informed consent signed before any study-specific evaluation is performed.
2.Female patients with age = 18 and = 50 years.
3.Patients requiring treatment for bacterial vaginosis.
4.Papanicolaou (Pap) smear/tests will be performed for subjects who do not have a negative test for intraepithelial lesion or malignancy or atypical squamous cells of undetermined significance in the past 24 months; in circumstances where the results of the Pap smear are pending at the time of randomization, eligible subjects may be randomized.
5.Women of childbearing potential must have a negative pregnancy test before randomization and may not be lactating or planning to become pregnant during the study period (up to Follow Up Visit 4 – Day 21-30).
6.Agreement of female subject of childbearing potential to use highly effective methods of contraception (progestin intrauterine device, all oral contraceptives, transdermal hormonal contraceptives) or to abstain from sexual intercourse during the treatment.
7.Willing to refrain from the use of intravaginal products during the treatment period (including spermicides, condoms, tampons etc.).
8.The positive result of BV blue test.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 185
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Patients with other infectious causes of vulvovaginitis (e.g., vulvovaginal candidiasis, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Herpes simplex, or human papillomavirus).
2.Patients with another vaginal or vulvar condition, which would confound the interpretation of the clinical response.
3.Patients who are currently receiving antibacterial therapy unrelated to BV
4.Known hypersensitivity/allergy to active ingredients of the study medications.
5.Vaginismus, dyspareunia.
6.Detection of urinary tract infection in urinalysis.
7.Clinically significant liver or kidney function impairment (eGFR<60 ml/min/1.73m2).
8.History of recurrent bacterial vaginosis (=3 episodes per year).
9.Clinically significant cardiovascular function impairment.
10.Severe hypertension and non-controlled diabetes.
11.Presence of known risk or of venous or arterial thromboembolism.
12.Undiagnosed abnormal vaginal bleeding, bleeding disorders, genital tumors.
13.Pregnancy and/or breastfeeding.
14.Participation in any other trial 30 days before initiation of the study.
15.Postmenopausal women.
16.Abuse of alcohol.
17.Any gynecological condition contraindicating the use of vaginal ovule or cream.
18.Use of any other local or systemic bactericidal, anti-protozoa or antifungal agent within the 2 weeks prior to the study start or during it.
19.Use spermicides, or diaphragms, intravaginal contraception delivery system, probiotics, hygiene products containing probiotics.
20.Presence of a sexually transmitted disease such as syphilis, gonorrhea, human papilloma virus, herpes zoster virus etc.
21.Previously diagnosed human immunodeficiency virus seropositivity or clinically diagnosed acquired immunodeficiency syndrome or its related complex.
22.Immunosuppressive condition (eg, end-stage renal disease) or is currently taking immunosuppressants, (eg, steroids, cyclosporine).
23.Malignancy of any type.
24.Any other condition the Investigator believes would interfere with the subject’s ability to provide informed consent, comply with study instructions, or puts the subject at undue risk.
25.The positive result of SARS-CoV-2 test.
26.Presence of test for intraepithelial lesion or malignancy or atypical squamous cells of undetermined significance.
27.Women currently menstruating or expecting menstruation within 1 week.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method