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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: Completed Early Phase 1 study, sponsored by J3 Bioscience.

NCT02029053 is a Early Phase 1 study that has completed, run by J3 Bioscience. The registered enrollment target is 21 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Assessment of patient reported vaginal lubrication/moisturization while the intravaginal ring is inserted.

Interventions

  • DEVICE Vaginal Lubrication Ring for Vaginal Dryness

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2014-01
Est. Completion 2014-05
Phase Early Phase 1
J3 Bioscience

3 total trials

What the finished NCT02029053 record still lists

NCT02029053 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (60% lower).

The record links to 0 conditions, and to 1 intervention - of which Vaginal Lubrication Ring for Vaginal Dryness is the first listed.

NCT02029053 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT02029053's enrollment target sits among peer trials

21 1130th of 2000 higher than 845 of 2,000 other Early Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Early 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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Source: ClinicalTrials.gov NCT02029053, the US trial registry maintained by the National Library of Medicine. NCT02029053 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.