Evaluation of Efficacy and Safety of Two New Formulations Compared to Gynomax® XL Ovule

NCT06056947 | Completed Phase 3

• 1 other identifier: MON580.130.3
• Study Type: interventional
• Target: 577
• Locations: 1 country
• Sites: 1

Brief Summary

Efficacy and safety of two new formulations compared to Gynomax® XL ovule in the treatment of trichomonal vaginitis, bacterial vaginosis, candidal vulvovaginitis and mixed vaginal infections was evaluated in this randomized, three-arms, multicentral study.

Conditions

Trichomonal Vaginitis; Bacterial Vaginosis; Candidal Vulvovaginitis; Mixed Vaginal Infections

Outcome Measures

Primary Outcomes (1)

• Percentage of patients who had complete response to treatment according to clinical findings

  Efficacy

  13 days (+/- 5 days) after treatment

Secondary Outcomes (3)

• Percentage of patients who had partial response to treatment according to clinical findings

  13 days (+/- 5 days) after treatment

• Percentage of patients who recovered according to microbiological findings

  13 days (+/- 5 days) after treatment

• Frequency and percentage of patients with SAEs/AEs in each arm

  13 days (+/- 5 days)

Study Arms (3)

fenticonazole + tinidazole + lidocaine vaginal ovule (EVEGYN A)

EXPERIMENTAL

EVEGYN A is a fixed-dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine vaginal ovule.

Drug: EVEGYN A

fenticonazole + tinidazole + lidocaine vaginal ovule (EVEGYN B)

EXPERIMENTAL

EVEGYN B is a fixed-dose combination of 600 mg fenticonazole nitrate + 2000 mg tinidazole + 100 mg lidocaine vaginal ovule.

Drug: EVEGYN B

Gynomax® XL Vaginal Ovule

ACTIVE COMPARATOR

Gynomax® XL is a fixed-dose combination of 300 mg tinidazole + 200 mg tioconazole nitrate + 100 mg lidocaine

Drug: Gynomax® XL Vaginal Ovule

Interventions

EVEGYN A DRUG

EVEGYN A: Fixed-dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine vaginal ovule Single dose, single administration (1x1)

fenticonazole + tinidazole + lidocaine vaginal ovule (EVEGYN A)

EVEGYN B DRUG

EVEGYN B: Fixed-dose combination of 600 mg fenticonazole nitrate + 2000 mg tinidazole + 100 mg lidocaine vaginal ovule Single dose, single administration (1x1)

fenticonazole + tinidazole + lidocaine vaginal ovule (EVEGYN B)

Gynomax® XL Vaginal Ovule DRUG

200 mg tioconazole + 300 mg tinidazole + 100 mg lidocaine single dose / day, during three consecutive days (1x1 / 3 days)

Gynomax® XL Vaginal Ovule

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female patients with age of ≥ 18 and ≤ 55 years who have a regular menstrual cycle (at least 10 times a year)
• Female patients who previously experienced vaginal intercourse
• Patients requiring treatment for bacterial vaginosis, candidal vulvovaginitis, trichomonal vaginitis or mixed infections according to the investigator's decision
• Signed informed consent

You may not qualify if:

• Known hypersensitivity to active ingredients (including their derivatives) of the study medications
• Vaginismus, endometriosis, dyspareunia
• Detection of urinary tract infection in urinalysis
• Pancreatitis, hypertriglyceridemia, liver diseases, benign or malign tumors and ongoing organ failure
• Usage of herbal medicines and drugs that interfere with microsomal enzymes, especially cytochrome P450 (phenytoin, phenobarbital, primidone, carbamazepine, rifampicin, topiramate, felbamate, griseofulvin, HIV protease inhibitors such as ritonavir, nucleoside reverse transcriptase inhibitors such as efavirenz)
• History of cardiovascular event
• Uncontrolled diabetes and hypertension
• Presence or known risk or of venous or arterial thromboembolism
• Undiagnosed abnormal vaginal bleeding, bleeding disorders, bleeding due to intrauterine device implantation during study period, presence of genital tumors
• Use of drugs containing ombitasvir / paritaprevir / ritonavir or dasabuvir during or two weeks before initiation of the study
• Pregnancy and/or breastfeeding
• Participation in any other trial 30 days before initiation of the study
• Postmenopausal women
• Chronic alcoholism
• Patients with organic neurological disorders

Sponsors & Collaborators

• Ege University: lead
• Monitor CRO: collaborator
• Exeltis Turkey: collaborator

Study Sites (1)

Ege University Family Planning and Infertility Application and Research Center

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Trichomonas Vaginitis; Vaginosis, Bacterial; Candidiasis, Vulvovaginal

Condition Hierarchy (Ancestors)

Trichomonas Infections; Protozoan Infections; Parasitic Diseases; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Candidiasis; Mycoses; Vulvovaginitis; Vulvitis; Vulvar Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Prof

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 28, 2023
• Study Start: July 20, 2020
• Primary Completion: May 6, 2021
• Study Completion: August 26, 2021
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)