Halted Phase II and Phase III (Integrated) female patients with bacterial vaginosis (BV), respectively vulvovaginal candidiasis (VVC)

A phase II/III multi-centre, open-label, parallel group study to prove the non-inferiority of safety and efficacy of Metronidazole/Neomycin Sulfate/ Nystatin, 500mg/ 65.000UI/100.000UI pessaries (Antibiotice SA) versus Tergynan® vaginal tablets (Bouchara–Recordati Laboratories) in the treatment of specific and non-specific vaginitis

EU CTIS ID: 2024-518862-28-00

What this study is testing

Efficacy comparison between Metronidazole/Neomycin Sulfate/ Nystatin, 500mg/ 65.000UI/100.000UI pessaries (Antibiotice SA) and Tergynan® vaginal tablets (Bouchara–Recordati Laboratories) considering the therapeutic cure (both clinical and microbiologic/mycological cure) after a 10-day treatment.

Phase II and Phase III (Integrated)

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

1. Diagnosis of bacterial vaginosis (BV) based on the presence of at least three of the following Amsel criteria: a. Homogeneous vaginal discharge (off white, yellowish, milky or grey, thin), b. positive KOH (whiff test), c. vaginal secretions pH of > 4.5, d. clue cells > /= 20 percent of vaginal squamous epithelial cells on saline "wet mount" or Gram coloration The BV diagnosis will be confirmed by a Nugent score equal or higher than seven on bacteriological analysis of vaginal samples.
10. Subjects must agree to abstain from sexual intercourse throughout the first 10 days of the study. Following the first 10 days, subjects must agree to use a non-lubricated condom when engaging in sexual intercourse.
11. Subjects must be willing to abstain from alcohol ingestion during the 10 days treatment period and for 1 day afterward.
12. Subjects must agree to refrain from the use of intra-vaginal products throughout the study (e.g., douches, feminine deodorant sprays, spermicides, lubricated condoms, tampons, and diaphragms).
13. Subject is willing and able to cooperate to the extent and degree required by this protocol at the discretion of the investigator.
2. Diagnosis of vulvovaginal candidiasis (VVC) based on the presence of hyphae or pseudohyphae on KOH or saline preparation; with a vaginal pH less than or equal to 4.5 and clinically must have at least two or more of the following signs and symptoms of VVC, each rated based on severity* with minimum composite score of 2. Signs include vulvovaginal edema, erythema, and/or excoriation. Symptoms include vulvovaginal itching, burning, and/or irritation. *Severity will be graded on a scale of 0-3 (absent = 0; mild = 1; moderate = 2; severe = 3).

You likely can't join if

1. Subjects with clinical manifestation of other active vaginal infections, such as infection by Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Herpes simplex type 2 (HSV-2, or genital herpes) or known infection with HPV, or another vaginal or vulvar condition, that in opinion of the Investigator might confuse interpretation of response to study product. (e.g.- erosive lichen planus, desquamative interstitial vaginitis, contact dermatitis involving the vulvar epithelium, allergy. The above-mentioned infections are detected during clinical examination, as per Investigator’s opinion and experience
10. Participation in any experimental study or ingestion of any experimental drug 12 months before the start of this study;
11. Consumes excessive amounts of alcohol, abuses drugs, or has any condition that would compromise compliance;
12. Subjects who in Investigator's opinion would be non-compliant or Subjects with other vaginal or vulvar conditions, which in the investigator's opinion may confound interpretation of clinical response;
13. Female subjects that are pregnant or lactating or planning to become pregnant during the study period;
14. Virgin female subjects.

See the full eligibility criteria

Who can join

1. Diagnosis of bacterial vaginosis (BV) based on the presence of at least three of the following Amsel criteria: a. Homogeneous vaginal discharge (off white, yellowish, milky or grey, thin), b. positive KOH (whiff test), c. vaginal secretions pH of > 4.5, d. clue cells > /= 20 percent of vaginal squamous epithelial cells on saline "wet mount" or Gram coloration The BV diagnosis will be confirmed by a Nugent score equal or higher than seven on bacteriological analysis of vaginal samples.
10. Subjects must agree to abstain from sexual intercourse throughout the first 10 days of the study. Following the first 10 days, subjects must agree to use a non-lubricated condom when engaging in sexual intercourse.
11. Subjects must be willing to abstain from alcohol ingestion during the 10 days treatment period and for 1 day afterward.
12. Subjects must agree to refrain from the use of intra-vaginal products throughout the study (e.g., douches, feminine deodorant sprays, spermicides, lubricated condoms, tampons, and diaphragms).
13. Subject is willing and able to cooperate to the extent and degree required by this protocol at the discretion of the investigator.
2. Diagnosis of vulvovaginal candidiasis (VVC) based on the presence of hyphae or pseudohyphae on KOH or saline preparation; with a vaginal pH less than or equal to 4.5 and clinically must have at least two or more of the following signs and symptoms of VVC, each rated based on severity* with minimum composite score of 2. Signs include vulvovaginal edema, erythema, and/or excoriation. Symptoms include vulvovaginal itching, burning, and/or irritation. *Severity will be graded on a scale of 0-3 (absent = 0; mild = 1; moderate = 2; severe = 3).
3. Post-menarche women, between 18 and 50 years old;
4. Participant is in general good health based on medical history, physical examination, vital signs, and pelvic examination.
5. Subjects who have regular menstrual cycles (Subjects with regular menstrual cycles with intervals between 21 to 35 days)
6. Subject is willing and able to provide written informed consent prior to any study related procedures being performed.
7. Women of child bearing potential must have a negative high sensitivity urine pregnancy test or negative serum pregnancy test result upon entry into the study.
8. Women of childbearing potential must agree to practice reliable contraception* for the 28-day period before enrollment through 30 days following treatment. * Acceptable birth control methods for the purposes of this study may include, but are not limited to, abstinence from intercourse with a malepartner, monogamous relationship with vasectomized partner, barrier methods to include non-lubricated condoms and diaphragms, intrauterine devices, and licensed hormonal methods. NuvaRing® contraceptive use will be prohibited from this study since the device can alter vaginal secretions.
9. Any Pap test performed in the prior 3 years must be normal or ASCUS Human papillomavirus (HPV) negative.

What rules you out

1. Subjects with clinical manifestation of other active vaginal infections, such as infection by Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Herpes simplex type 2 (HSV-2, or genital herpes) or known infection with HPV, or another vaginal or vulvar condition, that in opinion of the Investigator might confuse interpretation of response to study product. (e.g.- erosive lichen planus, desquamative interstitial vaginitis, contact dermatitis involving the vulvar epithelium, allergy. The above-mentioned infections are detected during clinical examination, as per Investigator’s opinion and experience
10. Participation in any experimental study or ingestion of any experimental drug 12 months before the start of this study;
11. Consumes excessive amounts of alcohol, abuses drugs, or has any condition that would compromise compliance;
12. Subjects who in Investigator's opinion would be non-compliant or Subjects with other vaginal or vulvar conditions, which in the investigator's opinion may confound interpretation of clinical response;
13. Female subjects that are pregnant or lactating or planning to become pregnant during the study period;
14. Virgin female subjects.
15. Subjects who have a known hypersensitivity to components of the formula.
16. Menstruating at the time of diagnosis or expected to menstruated during the course of the treatment (10 days)
2. Subjects diagnosed with cervical intraepithelial neoplasia) class 2 or class 3 (CIN 2 or 3) or carcinoma of the cervix;
3. Subjects who have undergone gynaecological procedures in the month prior to inclusion (such as cauterization of the cervix, cervical biopsy, high-frequency surgery);
4. Subjects who received intravaginal or systemic antimicrobial or antifungal therapy one-month prior randomization;
5. Subjects on immunosuppressive medications (such as corticosteroids, cyclosporine, etc.);
6. Knowledge of positive test result for human immunodeficiency virus or viral hepatitis B or C;
7. Active disease or history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinoma of the skin which is considered cured with minimal risk of recurrence
8. Diabetes Mellitus Type I or Type II;
9. Subjects diagnosed with Pelvic Inflammatory Disease;

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, 18-64 years. The study team makes the final eligibility decision.

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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.