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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: Completed Phase 1 study, sponsored by Izun Pharma.
NCT02313545 is a Phase 1 study that has completed, run by Izun Pharma. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
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
Interventions
- DRUG IZN-6NVS Cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2014-12 |
| Est. Completion | 2017-03 |
| Phase | Phase 1 |
What the finished NCT02313545 record still lists
NCT02313545 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 1 intervention - of which IZN-6NVS Cream is the first listed.
NCT02313545 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02313545's enrollment target sits among peer trials
50 973rd of 2000 higher than 984 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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