A prospective, multicentre, uncontrolled study of Geonistin vaginal tablets effectiveness with pharmacokinetic evaluation for unspecific and mixed vulvovaginal infections characterized by vaginal discharge

• Register: EUCTR
• Last refreshed on: 2 October 2017
• Main ID: EUCTR2016-000078-39-HR
• Date of registration: 06/07/2016
• Prospective Registration: No
• Primary sponsor: PLIVA Hrvatska d.o.o.
• Public title: A prospective, multicentre, uncontrolled study of Geonistin vaginal tablets effectiveness with pharmacokinetic evaluation for unspecific and mixed vulvovaginal infections characterized by vaginal discharge
• Scientific title: A prospective, multicentre, uncontrolled study of Geonistin vaginal tablets effectiveness with pharmacokinetic evaluation for unspecific and mixed vulvovaginal infections characterized by vaginal discharge - GENIE
• Date of first enrolment: 25/05/2016
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-000078-39
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Croatia

Contacts

• Name: Managing director
• Affiliation: Clinres farmacija d.o.o.

• Name: Managing director
• Affiliation: Clinres farmacija d.o.o.

Key inclusion & exclusion criteria

Inclusion criteria:
1. Unspecific and mixed vulvovaginal infections characterized by vaginal discharge (pathological and/or unusual) and at least one additional sign/symptom.
2. Women of reproductive age, who are =18 years of age.
3. Lactobacillary grade =2 in vaginal exam.
4. According to investigator’s judgment the patients should receive local treatment only.
5. Signed informed consent.

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 190
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
a. Trichomonas vaginalis infection (detected by wet preparation of vaginal smear or confirmed by OSOM® rapid test).
b. Neisseria gonorrhea infection (clinically suspected).
c. Chlamydia trachomatis infection (clinically suspected).
d. Infection with Herpes simplex virus (clinically suspected).
e. Patients with other vaginal or vulvar condition, which would confound the interpretation of clinical response.
f. Women with cervical carcinoma.
g. Women under treatment for cervical intraepithelial neoplasia (CIN).
h. Recurrent BV (three or more episodes of BV in 12 months).
i. Recurrent VVC (four or more VVC episodes in 12 months).
j. Use of a topical or systemic antimicrobial treatment within 30 days before the study.
k. On-going immunosuppressant treatment.
l. On-going systemic antimicrobial therapy.
m. On-going use of vaginal probiotics (oral and vaginal
capsules, and all other form
which helps regeneration of
vaginal flora).
n. Women currently menstruating or expecting menstruation within 1 week.
o. Women using an intrauterine contraceptive device.
p. Pregnancy (excluded by pregnancy urine test).
q. Lactation.
r. Patients who gave birth or underwent gynecological surgery within 2 months before the study.
s. History of allergic reactions to nystatin or oxytetracycline or to excipients of the pharmaceutical product.
t. Participation in another clinical study.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Unspecific and mixed vulvovaginal infections characterized by vaginal discharge.

Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

Intervention(s)

Trade Name: Geonistin vaginal tablets
Product Name: Geonistin vagianl tablets
Pharmaceutical Form: Vaginal tablet

Primary Outcome(s)

Secondary Objective: The secondary objectives of the study are as follows: To assess systemic exposure to oxytetracycline following local treatment of vulvovaginal infections with Geonistin vaginal tablets; Cure rate according to the Nugent score (where applicable); Microbiology results (outcome); to evaluate safety of Geonistin vaginal tablets.

Main Objective: The primary objective of the study is to evaluate the clinical effectiveness of Geonistin vaginal tablets administered in empirical treatment of female adult patients with unspecific and mixed vulvovaginal infections characterized by vaginal discharge (pathological and/or unusual)..

Primary end point(s): Clinical cure rate after 6 days of treatment.

Timepoint(s) of evaluation of this end point: Clinical effectiveness of 6 day treatment with Geonistin vaginal tablets in empirical treatment of vulvovaginal infections at day 13±2.

Secondary Outcome(s)

Secondary end point(s): Trough steady-state serum concentrations of oxytetracycline, Cure rate according to the Nugent score (where applicable), Microbiological cure rate, Safety evaluation.

Timepoint(s) of evaluation of this end point: 30 days after the start of treatment.

Secondary ID(s)

GEO-2014/01-HR

Source(s) of Monetary Support

PLIVA Hrvatska d.o.o.