A Phase III, randomized, controlled study of furazidin for bacterial vaginosis.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Adamed Pharma S.A.

Participant type

Patients

Age range

18-64 years

Gender

Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

23 Feb 2026 → ongoing

Decision date (initial)

2025-12-02

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

Primary objective is to demonstrate that the treatment with furazidin 5 mg vaginal tablets is not less effective than treatment with clindamycin 2% vaginal cream.

Secondary objectives 3

1. To demonstrate non-inferiority of Furazidin, vaginal tablets, 5 mg in comparison to clindamycin cream 2% in the scope of the microbiological cure.
2. To demonstrate that safety profile (based on the incidence of AE/SAE and bacterial vaginosis recurrences) of Furazidin, vaginal tablets, 5 mg is not worse than clindamycin cream 2%.
3. To demonstrate that participants’ quality of life during and after treatment with Furazidin, vaginal tablets, 5 mg is not worse than clindamycin cream 2%.

Conditions and MedDRA coding

Bacterial vaginosis

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. A written informed consent signed before any study-specific evaluation is performed.
2. Female patients with age ≥ 18 ≤ 65
3. Patients with bacterial vaginosis, diagnosed based on Amsel’s criteria.
4. PAP Results-Negative test result for intraepithelial lesion (LSIL), High-Grade Squamous Intraepithelial Lesion (HSIL), or malignancy in the past 12 months. If rial participants do not have a negative test result for LSIL, HSIL or malignancy in the past 12 months, PAP smear/tests in accordance with the Bethesda classification will be performed during screening. In circumstances where the results of the PAP smear are pending at the time of randomization, eligible trial participants may be randomized. In the case of ASCUS result (previous or from screening), test should be repeated in first possible term.
5. Women must have a negative pregnancy test before randomization and may not be lactating or planning to become pregnant during the study period up to Long Term Follow Up Visit 5
6. Agreement of female trial participant of childbearing potential to use highly effective methods of contraception according CTGA vr. 1.2 07Mar2024 (method that can achieve a failure rate of <1% per year when used consistently and correctly e.g. combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, progestin intrauterine device, all oral contraceptives, transdermal hormonal contraceptives with exception of spermicides, or diaphragms, intravaginal contraception) or to abstain from heterosexual intercourse from screening up to Long Term Follow Up Visit 5. For postmenopausal female trial participants it should no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
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

Exclusion criteria 25

1. Patients with active clinical symptoms of other infectious causes of vulvovaginitis-Vulvovaginal candidiasis, HSV or HPV).
2. Patients with positive test results for Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Syphilis.
3. Patients with another vaginal or vulvar condition, which would confound the interpretation of the clinical response.
4. Use of any other local or systemic bactericidal/bacteriostatic, anti-protozoa or antifungal agent within the 2 weeks prior to the study start.
5. Known hypersensitivity/allergy to active ingredients or any of the excipients of the study medications (including lincomycin).
6. History of antibiotic-associated colitis in medical history.
7. History vaginismus, dyspareunia in medical history.
8. Urinary tract infection within the 2 weeks prior to the study start and during screening. Uncomplicated UTI patients described as presence of at least two of the following clinical symptoms: dysuria, urinary frequency, urinary urgency, suprapubic pain.
9. Hepatic impairment with AST or ALT >5 x Upper Limit of Normal Clinically significant kidney function impairment (eGFR<60 ml/min/1.73m2).
10. History of recurrent bacterial vaginosis (≥3 episodes per period) in medical history within last 12 months.
11. Clinically significant cardiovascular function impairment-NYHA scale 3 and 4.
12. Uncontrolled severe hypertension ≥180/110 mmHg.
13. Uncontrolled diabetes HbA1C ≥7.5%.
14. Episodes of venous or arterial thromboembolism in Medical History.
15. Undiagnosed abnormal vaginal bleeding, genital tumors (excluding myoma) which in opinion of investigator are clinically significant.
16. Pregnancy and/or breastfeeding
17. Participation in any other trial 30 days before initiation of the study.
18. Dementia or altered mental status that would prohibit informed consent process.
19. Use spermicides, or diaphragms, intravaginal contraception delivery system, probiotics, hygiene products containing probiotics during the study.
20. Diagnosed human immunodeficiency virus (HIV) seropositivity or clinically diagnosed acquired immunodeficiency syndrome (AIDS) or its related complex.
21. Diagnosed hepatitis B or C viral infection.
22. Immunosuppressive condition (e.g., end-stage renal disease) or is currently taking immunosuppressants, (e.g., steroids for systemic use, cyclosporine); Inhaled steroids and locally applied steroids are not considered immunosuppressive therapy.
23. Malignancy of any type diagnosed within last 5 years.
24. Any other condition the Investigator believes would interfere with the trial participant’s ability to provide informed consent, comply with study instructions, or puts the trial participant at undue risk.
25. Women currently menstruating or expecting menstruation within 1 week.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Clinical cure rate at Visit 3 (test of cure, Day 8-10), based on Amsel criteria. Clinical cure is defined as the resolution of the abnormal vaginal discharge, a negative whiff test, and the presence of clue cells at less than 20% of the total epithelial cells on microscopic examination of the saline wet mount.

Secondary endpoints 5

1. Percentage of participants with Nugent score ranging from 0 to 3 (Visit 4, Day 21-30).
2. Percentage of participants who achieved clinical cure at Visit 3 (Test of cure, Day 8-10) and had a Nugent score ranging from 0 to 3 (Visit 4, Day 21-30).
3. Incidence of adverse events (AEs) and serious adverse events (SAEs), both related and unrelated to the investigational medicinal product (IMP).
4. Percentage of Bacterial Vaginosis recurrences within 12 weeks of follow-up (assessed with Amsel criteria) in participants who achieved clinical cure status at Visit 3 (Day 8-10).
5. Assessment of participants’ quality of life based on VAS scale from the baseline visit to the end of the observation (Visit 5, at least in 13 or 14 week after end of treatment).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Adamed Pharma S.A.

Sponsor organisation

Adamed Pharma S.A.

Address

Ul. Mariana Adamkiewicza 6a, Pienkow Pienkow

City

Czosnow

Postcode

05-152

Country

Poland

Scientific contact point

Organisation

Adamed Pharma S.A.

Contact name

Blanka Seklecka

Public contact point

Organisation

Adamed Pharma S.A.

Contact name

Blanka Seklecka

Third parties 1

Locations

4 EU/EEA countries · 26 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 64 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications