MedTrace Logo

Phase I-B Study to Evaluate the Safety, Tolerability and Efficacy of IZN-6NVS for the Treatment of AV and DIV

NCT02313545 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-03-14

No results posted yet for this study

Summary

In this open label study, 50 eligible women will be assigned to receive the investigational product (IZN-6NVS) - 2.5 g of cream/day for 14 days, followed by 3 applications per week for the next 4 weeks. Clinical assessment of the severity of vaginitis will be performed at baseline and after 2 and 6 weeks of treatment.

The study will evaluate safety, tolerability and efficacy of IZN-6NVS vaginal cream, in the treatment of atrophic vaginitis (AV) and desquamative inflammatory vaginitis (DIV).

Conditions

  • Atrophic Vaginitis

Interventions

DRUG

IZN-6NVS Cream

IZN-6NVS, a hydrocream containing three herbal extracts, is a polymolecular agent derived from botanical sources. It is composed of a blend of three herbal extracts, Centella asiatica, Echinacea purpurea, and Sambucus nigra. Cream concentration: 5%

Sponsors & Collaborators

  • Izun Pharma Ltd

    lead INDUSTRY

Principal Investigators

  • Gabe Nussbaum, MD, PhD · Izun Pharma Ltd

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-12-31
Completion
2017-03-31

Countries

  • United States
  • Israel

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02313545 on ClinicalTrials.gov