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NCT06101303 · ClinicalTrials.gov registry record
Endometriosis Pain
A clinical trial of Endometriosis and Pelvic Pain, sponsored by Washington University School of Medicine.
- Recruiting
- Registry status
- 120
- Enrollment target
- 1
- Study location
NCT06101303: Recruiting study of Endometriosis and Pelvic Pain, sponsored by Washington University School of Medicine.
NCT06101303 is a study of Endometriosis and Pelvic Pain that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 120 participants, below the 262-participant average among 48 other Endometriosis trials with a reported enrollment target (54% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06101303, a study of Endometriosis and Pelvic Pain, is actively recruiting participants, sponsored by Washington University School of Medicine.
- RECRUITING
- Registry status
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
Aim 1. To determine the factors contributing to pain in patients with chronic pelvic pain with and without endometriosis Aim 2. To determine the changes following endometriosis lesion removal surgery in pain and sex hormone levels. Aim 3. To identify factors predicting clinical pain reduction after lesion removal surgery. Additional exploratory aims might compare subgroups of patients such as patients with vs. without endometriosis, with vs. without additional chronic pain syndromes, and with vs. without hormonal treatment. In addition, the role of lesion-specific immune signatures and psychological factors on pain will be explored. Patients with pelvic pain potentially due to endometriosis will complete questionnaires including social, health, behavioral, and psychological questionnaires. Patients will also complete a 2.5 hours study visit of psychophysical assessments of thermal and pressure stimuli. In addition, blood, urine, and saliva samples will be collected for hormonal, immune, and genetic analyses. Additional samples might be collected and stored for future analyses. For some participants, these procedures will be completed several times, including before the surgery as well as 3 months, 6 months and 1 year after surgery. After the surgery, surveys assessing pain and other symptoms will be sent every week on the first month and then monthly for 1 year. In addition, during the surgery, biopsies will be collected and analyzed to determine hormonal, immune and genetic factors. For adolescents, a parent/legal guardian will be asked to assist in completing some of the health-related surveys (i.e., physical developmental survey, health survey, migraine history survey).
Primary Outcome
Rating the pain intensity level using a numerical pain scale (0-100) or visual analog scale
Conditions Studied
Interventions
- OTHER Psychophysical assessment
- BEHAVIORAL Psychophysical assessments of experimental pain
- DIAGNOSTIC_TEST Blood, urine and saliva samples
- PROCEDURE Biopsy and surgery-related data.
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2023-09-29 |
| Est. Completion | 2029-09-01 |
What NCT06101303 shows while recruiting
NCT06101303 is an observational study that tracks outcomes without assigning an intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 262-participant average among 48 other Endometriosis trials with a reported enrollment target (54% lower).
The record links to 2 conditions, with Endometriosis appearing as the primary indexed condition, and to 4 interventions - of which Psychophysical assessment is the first listed.
NCT06101303 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT06101303 about?
NCT06101303 is a clinical study titled "Endometriosis Pain". Aim 1. To determine the factors contributing to pain in patients with chronic pelvic pain with and without endometriosis Aim 2. To determine the changes following endometriosis lesion removal surgery in pain and sex hormone levels. Aim 3. To identify factors predicting clinical pain reduction after...
What is the current status of trial NCT06101303?
This trial is currently recruiting. The enrollment target is 120 participants. The study started on 2023-09-29. Estimated completion is 2029-09-01.
What conditions does trial NCT06101303 study?
This clinical trial studies the following conditions: Endometriosis, Pelvic Pain.
What interventions are being tested in trial NCT06101303?
The interventions under investigation include: Psychophysical assessment (OTHER), Psychophysical assessments of experimental pain (BEHAVIORAL), Blood, urine and saliva samples (DIAGNOSTIC_TEST), Biopsy and surgery-related data. (PROCEDURE).
Who is sponsoring clinical trial NCT06101303?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06101303 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06101303's enrollment target sits among peer trials
120 18th of 48 higher than 27 of 48 other Endometriosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Endometriosis 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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