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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 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.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06101303
The ClinicalTrials.gov registry entry for NCT06101303 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 262-participant average among 48 other Endometriosis trials with a reported enrollment target (54% lower). The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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