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NCT02313545 · ClinicalTrials.gov registry record · Phase 1
Phase I-B Study to Evaluate the Safety, Tolerability and Efficacy of IZN-6NVS for the Treatment of AV and DIV
A Phase 1 study, sponsored by Izun Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT02313545 is a Phase 1 study that has completed, run by Izun Pharma. The registered enrollment target is 50 participants.
The verdict
NCT02313545, a Phase 1 study, has completed, sponsored by Izun Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
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).
Interventions
- DRUG IZN-6NVS Cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2014-12 |
| Est. Completion | 2017-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02313545
The ClinicalTrials.gov registry entry for NCT02313545 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Izun Pharma, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which IZN-6NVS Cream is the first listed.
NCT02313545 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02313545 about?
NCT02313545 is a clinical study titled "Phase I-B Study to Evaluate the Safety, Tolerability and Efficacy of IZN-6NVS for the Treatment of AV and DIV". 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 ...
What is the current status of trial NCT02313545?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2014-12. Estimated completion is 2017-03.
What interventions are being tested in trial NCT02313545?
The interventions under investigation include: IZN-6NVS Cream (DRUG).
Who is sponsoring clinical trial NCT02313545?
This trial is sponsored by Izun Pharma, which has 2 total clinical trials registered on ClinicalTrials.gov.
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