Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Izun Pharma Ltd
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.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
