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NCT02029053 · ClinicalTrials.gov registry record · Early Phase 1
Preliminary Study of a Vaginal Lubrication Ring to Treat the Symptoms of Vaginal Dryness
A Early Phase 1 study, sponsored by J3 Bioscience.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 21
- Enrollment target
NCT02029053 is a Early Phase 1 study that has completed, run by J3 Bioscience. The registered enrollment target is 21 participants.
The verdict
NCT02029053, a Early Phase 1 study, has completed, sponsored by J3 Bioscience.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
This is a pilot study, assessing the ability and safety of the use of VR101 intravaginal ring to relieve the symptoms of vaginal dryness, in peri and post-menopausal women. VR1010 is designed to release glycerol. The study will assess the duration of lubrication/ moisturization of the vagina with the VR101 intravaginal ring in place (up to 7 days) and participant satisfaction of the device. Study participants will insert the intravaginal ring and leave it in place for an initial 7 days and then repeat this process a 2nd time. Participants will respond to questionnaires, complete a daily diary and come in for 4 separate study visits. Each study visit will involve a brief vaginal exam. Upon removal of the initially inserted device (7 days after first study visit), participants will insert a second device for an additional 7 days and undergo the same evaluation.
Interventions
- DEVICE Vaginal Lubrication Ring for Vaginal Dryness
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2014-01 |
| Est. Completion | 2014-05 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02029053
The ClinicalTrials.gov registry entry for NCT02029053 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is J3 Bioscience, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Vaginal Lubrication Ring for Vaginal Dryness is the first listed.
NCT02029053 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02029053 about?
NCT02029053 is a clinical study titled "Preliminary Study of a Vaginal Lubrication Ring to Treat the Symptoms of Vaginal Dryness". This is a pilot study, assessing the ability and safety of the use of VR101 intravaginal ring to relieve the symptoms of vaginal dryness, in peri and post-menopausal women. VR1010 is designed to release glycerol. The study will assess the duration of lubrication/ moisturization of the vagina with th...
What is the current status of trial NCT02029053?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 21 participants. The study started on 2014-01. Estimated completion is 2014-05.
What interventions are being tested in trial NCT02029053?
The interventions under investigation include: Vaginal Lubrication Ring for Vaginal Dryness (DEVICE).
Who is sponsoring clinical trial NCT02029053?
This trial is sponsored by J3 Bioscience, which has 3 total clinical trials registered on ClinicalTrials.gov.
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