| NCT ID | NCT06101303 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Washington University School of Medicine |
| Condition | Pelvic Pain |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-09-29 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2023-09-29 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
Inclusion criteria: * Patients with pelvic pain with and without endometriosis scheduled for an operative laparoscopic surgery for endometriosis diagnosis and/or treatment * Age 12-45 * Females Exclusion criteria: * Pregnancy * Planned hysterectomy or oophorectomy * Co-occurring vaginismus and/or vulvodynia * For patients aged 12-17 not having a parent/legal guardian willing to sign the consent and answer surveys about their child's health
Contact & Investigator
Hadas Nahman-Averbuch, PhD
PRINCIPAL INVESTIGATOR
Washington University School of Medicine
Frequently Asked Questions
Who can join the NCT06101303 clinical trial?
This trial is open to female participants only, aged 12 Years or older, up to 45 Years, studying Pelvic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06101303 currently recruiting?
Yes, NCT06101303 is actively recruiting participants. Contact the research team at painlab@wustl.edu for enrollment information.
Where is the NCT06101303 trial being conducted?
This trial is being conducted at St Louis, United States.
Who is sponsoring the NCT06101303 clinical trial?
NCT06101303 is sponsored by Washington University School of Medicine. The principal investigator is Hadas Nahman-Averbuch, PhD at Washington University School of Medicine. The trial plans to enroll 120 participants.