Atrophic Vaginitis Clinical Trial
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
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).
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.
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