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NCT03150407 · ClinicalTrials.gov registry record · NA
Use of J3 Bioscience Lubricating Intravaginal Ring VR101 to Relieve the Symptoms of Vaginal Dryness
A NA study of Postmenopausal Symptoms and Menopause Related Conditions, sponsored by J3 Bioscience.
- Completed
- Registry status
- NA
- Development phase
- 72
- Enrollment target
- 2
- Study locations
NCT03150407: Completed NA study of Postmenopausal Symptoms and Menopause Related Conditions, sponsored by J3 Bioscience.
NCT03150407 is a NA study of Postmenopausal Symptoms and Menopause Related Conditions that has completed, run by J3 Bioscience. The registered enrollment target is 72 participants, below the 87-participant average among 7 other Postmenopausal Symptoms trials with a reported enrollment target (17% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03150407, a NA study of Postmenopausal Symptoms and Menopause Related Conditions, has completed, sponsored by J3 Bioscience.
- COMPLETED
- Registry status
- NA
- Development phase
- 72 participants
- Enrollment target
- 2
- Study locations
Study Summary
This investigation is designed to demonstrate the safety and efficacy of the VR101 lubricating intravaginal ring (IVR) in treating the symptoms of vaginal dryness. In the proposed investigation, participants will use VR101 devices and sham control rings in a crossover study design. All participants who successfully complete the crossover study will be given the option to continue using VR101 for a total of 13 consecutive weeks to evaluate the long-term safety of the new device.
Primary Outcome
The Vaginal Health Index (VHI) ranges from 5 to 20 and is calculated via addition of clinician-determined ratings for Vaginal Elasticity, Fluid Volume, Epithelial Integrity, Moisture and pH (each ranges from 1 to 5, with 5 being the best).
Conditions Studied
Interventions
- DEVICE VR101 Device (Efficacy)
- OTHER Sham Control Ring
- DEVICE VR101 Device (Safety)
Study Locations (2)
Idaho
- Advanced Clinical Research, Inc. (ACR Idaho) - Meridian
Utah
- Advanced Clinical Research, Inc. (ACR Utah) - West Jordan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2017-05-01 |
| Est. Completion | 2017-11-30 |
| Phase | NA |
What the finished NCT03150407 record still lists
NCT03150407 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 87-participant average among 7 other Postmenopausal Symptoms trials with a reported enrollment target (17% lower).
The record links to 2 conditions, with Postmenopausal Symptoms appearing as the primary indexed condition, and to 3 interventions - of which VR101 Device (Efficacy) is the first listed.
NCT03150407 reports a single indexed study location in Idaho, Utah.
Frequently Asked Questions
What is clinical trial NCT03150407 about?
NCT03150407 is a clinical study titled "Use of J3 Bioscience Lubricating Intravaginal Ring VR101 to Relieve the Symptoms of Vaginal Dryness". This investigation is designed to demonstrate the safety and efficacy of the VR101 lubricating intravaginal ring (IVR) in treating the symptoms of vaginal dryness. In the proposed investigation, participants will use VR101 devices and sham control rings in a crossover study design. All participants ...
What is the current status of trial NCT03150407?
This trial is currently completed. It is a NA study. The enrollment target is 72 participants. The study started on 2017-05-01. Estimated completion is 2017-11-30.
What conditions does trial NCT03150407 study?
This clinical trial studies the following conditions: Postmenopausal Symptoms, Menopause Related Conditions.
What interventions are being tested in trial NCT03150407?
The interventions under investigation include: VR101 Device (Efficacy) (DEVICE), Sham Control Ring (OTHER), VR101 Device (Safety) (DEVICE).
Who is sponsoring clinical trial NCT03150407?
This trial is sponsored by J3 Bioscience, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03150407 being conducted?
This trial has 2 study locations across Idaho, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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