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NCT06397885 · ClinicalTrials.gov registry record
Prospective on Market Patient-reported Outcomes for Milli
A clinical trial of Dyspareunia and Vaginismus, sponsored by Materna Medical.
- Active
- Registry status
- 200
- Enrollment target
- 1
- Study location
NCT06397885: Active study of Dyspareunia and Vaginismus, sponsored by Materna Medical.
NCT06397885 is a study of Dyspareunia and Vaginismus that is active but no longer recruiting, run by Materna Medical. The registered enrollment target is 200 participants, above the 53-participant average among 10 other Dyspareunia trials with a reported enrollment target (277% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06397885, a study of Dyspareunia and Vaginismus, is active but no longer recruiting, sponsored by Materna Medical.
- ACTIVE NOT RECRUITING
- Registry status
- 200 participants
- Enrollment target
- 1
- Study location
Study Summary
To assess the effectiveness of the Milli device in achieving vaginal intercourse
Primary Outcome
Ability to achieve full vaginal penetration with the penis of the partner (intercourse) as measured by the Penetration Efficiency Questionnaire (Score of ≥2 on PEQ Question #1) at six months
Conditions Studied
Interventions
- DEVICE Milli Vaginal Dilator
Study Locations (1)
California
- Materna Clinic - Mountain View
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2024-05-12 |
| Est. Completion | 2025-12-30 |
What the registry record for NCT06397885 still lists
NCT06397885 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, above the 53-participant average among 10 other Dyspareunia trials with a reported enrollment target (277% higher).
The record links to 2 conditions, with Dyspareunia appearing as the primary indexed condition, and to 1 intervention - of which Milli Vaginal Dilator is the first listed.
NCT06397885 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06397885 about?
NCT06397885 is a clinical study titled "Prospective on Market Patient-reported Outcomes for Milli". To assess the effectiveness of the Milli device in achieving vaginal intercourse
What is the current status of trial NCT06397885?
This trial is currently active not recruiting. The enrollment target is 200 participants. The study started on 2024-05-12. Estimated completion is 2025-12-30.
What conditions does trial NCT06397885 study?
This clinical trial studies the following conditions: Dyspareunia, Vaginismus.
What interventions are being tested in trial NCT06397885?
The interventions under investigation include: Milli Vaginal Dilator (DEVICE).
Who is sponsoring clinical trial NCT06397885?
This trial is sponsored by Materna Medical, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06397885 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06397885's enrollment target sits among peer trials
200 2nd of 10 the highest of 10 other Dyspareunia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dyspareunia 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.
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