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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase I-B Study to Evaluate the Safety, Tolerability and Efficacy of IZN-6NVS for the Treatment of Atrophic Vaginitis or Desquamative Inflammatory Vaginitis

Brief 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).


Detailed Summary:

This will be a Phase IB study comprised of three study groups:

  • Group 1: Women who are naturally or surgically menopausal and symptomatic for AV, but who decline treatment with topical or systemic estrogen.
  • Group 2: Women rendered menopausal as a result of pharmacologic treatment (including, but not limited to, aromatase inhibitor treatment, selective estrogen receptor modifiers (SERMs), and GnRH analog treatment), who decline treatment with topical or systemic estrogen.
  • Group 3: Pre-menopausal women diagnosed with DIV.

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).

20 eligible women of groups 1 and 2 and up to 10 eligible women of group 3 will be assigned to receive 2.5 g of cream/day for the first 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, which will be the end of the study. Patient reported symptom severity will be assessed by questionnaire at baseline and after 2 and 6 weeks of treatment, and at follow-up.


Sponsor: Izun Pharma Ltd

Current Primary Outcome:

  • Safety basis of the following parameters: - General Toxicity: Vital signs (temperature, blood pressure, pulse rate, respiratory rate). - Adverse events and toxicity [ Time Frame: 6 weeks ]

    Safety and tolerability will be evaluated on the basis of the following parameters:

    • General Toxicity: Vital signs (temperature, blood pressure, pulse rate, respiratory rate).
    • Adverse events and toxicity
  • Change in composite score of vaginal symptoms as assessed by subject questionnaire from baseline [ Time Frame: Day 0, Day 14, Day 42, Day 84 ]
    At each time pion mentioned above, subjects will complete a Vaginal Symptoms questionnaire, subject will complete the questionnaire on their own.
  • Change in VMI (Vaginal Maturation Index) [ Time Frame: Day 0, Day 14, Day 42 ]
    At each time pion mentioned above, Cells will be collected to determine the vaginal maturation index.
  • Change in vaginal pH [ Time Frame: Day 0, Day 14, Day 42 ]
    At each time pion mentioned above, Vaginal pH will be determined
  • Change in pro-inflammatory cytokine levels in vaginal secretions [ Time Frame: Day 0, Day 14, Day 42 ]
    At each time pion mentioned above, vaginal secretions will be sampled by swab and samples will be frozen for determination of cytokine levels at a later time piont.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Izun Pharma Ltd

Dates:
Date Received: December 7, 2014
Date Started: December 2014
Date Completion: March 2017
Last Updated: November 13, 2016
Last Verified: November 2016