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