Symptomatic Vaginitis due to Bacterial Vaginosis, Candidiasis or Trichomoniasis MedDRA version: 9.1 Level: PT Classification code 10062167 Term: Vaginitis bacterial MedDRA version: 9.1 Level: LLT Classification code 10046950 Term: Vaginitis MedDRA version: 9.1 Level: LLT Classification code 10046958 Term: Vaginitis trichomonal MedDRA version: 9.1 Level: LLT Classification code 10048238 Term: Yeast vaginitis
Conditions
Interventions
Product Name: Pentamycin 10 mg Vaginal Tablets
Pharmaceutical Form: Vaginal tablet
INN or Proposed INN: Pentamycin
CAS Number: 6834-98-6
Concentration unit: mg milligram(s)
Concentration type: equal
C
Sponsors
Lumavita AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Female at least 18 yrs old • With a negative urinary pregnancy test before inclusion in the study, • Practicing a reliable contraception method such as hormonal contraception, intrauterine device, condom or diaphragm • Patients who are able to understand the protocol and have given informed consent • Patients with symptomatic vaginitis: discharge (leucorrhea), itching, burning, irritation, edema, erythema and/or excoriation of the vagina/vulva, painful sexual intercourse (dyspareunia). (Rating: absent = 0; mild = 1; moderate = 2; severe = 3). • With the following findings after saline wet mount and potassium hydroxide (KOH) workup: For Bacterial Vaginosis: Amsel’s criteria require at least three findings: - Thin homogenous vaginal discharge, - Vaginal secretion pH of >4.5, - Presence of “clue cells" on microscopic examination of the saline “wet mount” - Positive “whiff test”: Fishy odor of the vaginal discharge with the addition of a drop of 10% KOH. For Candidiasis: - White, creamy, and curdy (cottage cheese-like) vaginal discharge, adherent to the epithelium. - A screening KOH preparation from the inflamed vaginal mucosa reveals yeast forms (hyphae/pseudohyphae) or budding yeasts. For Trichomoniasis: - Vaginal discharge: copious frothy discharge (white to greenish-yellow) and a raised punctate erythema of the cervix and upper portion of the vagina (strawberry cervix). The discharge is often yellow. Sometimes, it is thick enough to be confused with candidiasis - Positive wet mount: T. vaginalis is an oval- or fusiform-shaped protozoan that, with erratic, twitching motility. A large number of WBCs and epithelial cells are observed. Slides must be read within 20 minutes of obtaining sample due to loss of characteristic motility of the trichomonads. The presence of flagellated, pyriform protozoa indicates a positive result. In case of mixed infection (e.g.: bacteria and candida) the patient will be allocated to the group with the dominant pattern. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients who are pregnant. A urinary pregnancy test must be performed before inclusion in the study, • Patients who are lactating • Patients with a history of liver or renal dysfunction defined as - AST, ALT more than 3xULN - serum creatinine equal or more than 250 micromol/l • Patients who have other acute gynecological symptoms except for vaginitis (e.g., salpingitis, endometriosis) at the time of screening or admission, • Patients who are unwilling to suspend the use during the study period of other vaginal products such as douches, tampons, spermicides, or herbal preparations, • Patients who have received any other investigational drug within 1 month prior to screening or enrollment, • Serious recent medical condition which makes the patients unsuitable for study participation, • Patients with a concomitant infection that needs an additional antimicrobial agent, • Medical, sociological, or psychological condition which would make the subject unlikely to follow the study protocol, • Inability to undergo repeat treatment, clinical evaluations, and other diagnostic procedures required by the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess efficacy on: - bacteriological, mycological (candida) and protozoal (Trichomoniasis) infection outcome and on - clinical outcome (symptoms) ;Secondary Objective: To assess safety and tolerability;Primary end point(s): Bacterial Vaginosis: Clinical Cure defined as complete resolution of the clinical findings (Amsel’s criteria) from the entry visit: • The original discharge characteristic of bacterial vaginosis has returned to a normal physiological discharge which varies in appearance and consistency depending on the menstrual cycle. • The whiff test is negative for any amine (“fishy”) odor • The saline wet mount is negative for clue cells • The pH is <4.7 Candidiasis: Therapeutic Cure: Patient who is considered both clinical cure (complete resolution of signs and symptoms of the vulvovaginal infection) and mycological eradication at Visit 3 (day 21 to 30 of the study). Trichomoniasis: Therapeutic Cure: Patient who is considered both clinical cure (resolution of trichomoniasis discharge) and protozoal eradication at Visit 3 (day 21 to 30 of the study). This composite endpoint is made up of • the clinical cure rate and • the mycological / protozoal outcome (eradication or persistence) for candidiasis / trichomoniasis | — |
Countries
Estonia, Germany, Hungary
Outcome results
None listed