vaginitis MedDRA version: 14.0 Level: LLT Classification code 10046950 Term: Vaginitis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Clotrigel C
Pharmaceutical Form: Pessary
CAS Number: 23593-75-1
Other descriptive name: CLOTRIMAZOLE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2
Sponsors
Glenmark Farmaceutica LTDA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Female subjects aged ?18 and ?60 years. Subjects who provide a written Informed Consent, which includes agreement to comply with all protocol-indicated study requirements, including a negative UPT for those of child-bearing potential. Subjects deemed reliable and mentally competent to complete the study by the study personnel. Subjects with a diagnosis of symptomatic mixed vaginitis, defined as having the following: ?Bacterial vaginosis (BV), as evidenced by: ?the presence of clue cells ?20% of the total epithelial cells on microscopic examination of a saline wet mount ?off-white (milky or gray), thin, homogeneous discharge with minimal or absent pruritus and inflammation of the vulva and vagina ?vaginal secretion with a pH of >4.5 ?a fishy odor of the vaginal discharge with the addition of a drop of 10% potassium hydroxide (KOH) (i.e., a positive whiff test) ?a Gram?s stain Nugent Score of ?7 in the absence of clue cells and ?4 in the presence of clue cells ?Vulvovaginal candidiasis (VVC), as evidenced by: ?Clinical signs and symptoms including itching, burning, irritation, edema, erythema, and/or excoriation of the vagina and/or the vulva ?A 10% KOH test of vaginal discharge which demonstrates yeast forms (hyphae/pseudohyphae) or budding yeasts Subjects must agree to abstain from sexual intercourse for the duration of study treatment (either 3 or 10 days). Following the treatment period and until Visit 2, subjects must agree to use a non-lubricated condom when engaging in sexual intercourse.Subjects must agree to refrain from the use of intravaginal products throughout the study (e.g., douches, feminine deodorant sprays, spermicides, lubricated condoms, tampons, nonoxynol-9 [N-9] products, and diaphragms). Subjects must agree to abstain from alcohol for the duration of study treatment and at least 2 days post-study treatment (at least 5 or 12 days). 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 184 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects who are pregnant or breast feeding at the time of Day 0 or intend on becoming pregnant during the study. Subjects suffering from a disease or disorder (e.g., diabetes, an immunodeficiency disorder [such as Human Immunodeficiency Virus (HIV) infection]) that predisposes her to recurrent mycological infection. Subjects who have a gynecological condition contraindicating the use of intravaginal ovules or creams. Subjects on current therapy with immunosuppressants and/or corticosteroids. Subjects who used intravaginal or systemic antimicrobial therapy within 14 days of Day 0. Subjects who used intravaginal or systemic antifungal therapy within 7 days of Day 0. Subjects with other infectious causes of vaginitis (e.g., Trichomonas vaginalis [or any other protozoa], Chlamydia trachomatis, Neisseria gonorrhoeae, Herpes simplex, or human papilloma virus [HPV]) as confirmed by the rapid diagnostic test FemLab® Vaginitis Test Kit, which will be done at Screening. Subjects with another vaginal or vulvar condition that would confound the interpretation of the clinical response.Subjects who have any vaginal bleeding. Subjects who are anticipating menses during the study treatment period (the next 10 days). Subjects receiving treatment or surgery during the study period for cervical intraepithelial neoplasia (CIN) or cervical carcinoma. Subjects receiving treatment for anticoagulation (e.g., coumadin, warfarin) during the four weeks prior to Day 0, with the exception of low-dose aspirin (maximum 100 mg/day) for use as a cardiovascular prophylaxis. Subjects with a known allergy or sensitivity to any of the study drugs, components or derivatives of the formulation excipients, or with chemically related similar drugs or formulation additives. Subjects who took disulfuram within 14 days of Day 0. 1Subjects who used any investigational agent within 30 days of Day 0. Subjects who have a medical disorder or other condition that, in the opinion of the Investigator or Sponsor, would preclude accurate evaluation or interfere with participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and safety of clotrimazole/clindamycin 200 mg/100 mg FDC) ovules in the treatment of mixed vaginitis.The primary efficacy endpoint is the Therapeutic Cure, defined as the subject achieving all 3 cures, i.e., Clinical, Mycological, and Bacterial Cures;Secondary Objective: A secondary objective is to evaluate the safety of the eggs of clotrimazole / clindamycin (200 mg/100 mg, ADF) in the treatment of vaginitis of mixed etiology.;Primary end point(s): The primary efficacy endpoint is the Therapeutic Cure, defined as the subject achieving all 3 cures, i.e., Clinical, Mycological, and Bacterial Cures;Timepoint(s) of evaluation of this end point: At visit 2 (end of study / test of cure [FdE / TOC] days 21 to 30). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Scored the severity of clinical signs and symptoms reported by the patient, itching, vaginal discharge (eg., Color, odor, amount), irritation, itching, edema, dyspareunia, and dysuria;Timepoint(s) of evaluation of this end point: Day 0, days 4 to 6, days 11 to 13 and days 21 to 30 | — |
Countries
Spain
Contacts
Public ContactAnna Jurczynska
Quantum Experimental S.L.
Outcome results
None listed