Completed

Understanding Neural Immune Mechanisms and Genetic Influences on Chronic Pelvic Pain in Women with Endometriosis

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Study Aim

This study aims to observe and understand the menstrual dynamics of systemic cytokine expression in endometriosis, focusing on measuring the expression of pro-inflammatory cytokines, stem cells, immunologic activity, and neurotransmitters in endometriosis lesions and the endometrium in women with chronic pelvic pain.

What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Urogenital Diseases+3

+ Genital Diseases

+ Endometriosis

From 18 to 50 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: April 2004
See protocol details

Summary

Principal SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
Last updated: February 6, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 22, 2004

Actual date on which the first participant was enrolled.

Endometriosis, a condition where endometrial tissue grows outside the uterus, often leads to chronic pelvic pain in women during their reproductive years. This study aims to deepen our understanding of this pain and discover new treatment methods. Not all women with endometriosis experience pain, and some feel pain in areas not related to the disease location. Current treatments, which involve altering hormone levels or surgically removing endometriosis tissue, only provide temporary relief. This suggests that the current approach to classifying and treating pain may not be sufficient. The study will explore how sex hormones, pain processing, immune system substances, and pain-related genes interact to cause chronic pelvic pain in women with endometriosis. Participants in this observational study will undergo various assessments. The study will measure changes in hormonal and immune substances in the blood, endometriosis lesions, and normal endometrial tissue. It will also evaluate the role of the nerve, muscle, and skeletal systems in pelvic pain through a comprehensive pain assessment. Additionally, the study will investigate how stress hormones may contribute to chronic pain. The primary outcome includes evaluating menstrual cycle variation in systemic secretion of inflammatory mediators (IL-6) and hormones, estradiol and progesterone. The study will also measure the expression of pro-inflammatory cytokines, stem cells, immunologic activity, and neurotransmitters in endometriosis lesions and the endometrium.

Official TitleThe Neural Immune Mechanisms and Genetic Influences on Chronic Pelvic Pain in Women With Endometriosis
NCT00073801
Principal SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
Last updated: February 6, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

78 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesEndometriosisFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleFemale Urogenital Diseases

Criteria

8 inclusion criteria required to participate
Are using abstinence, mechanical (condoms, diaphragms) or sterilization methods of contraception and are willing to continue using them throughout the study.

Willing and able to comply with study requirements.

BMI < than 32 kg/m^2.

Excellent health other than a three-month history of pelvic pain and documented endometriosis at laparoscopy. Chronic medications may be acceptable at the discretion of the Principal Investigator (PI). Use of antidepressants, medications for migraines and headaches, allergy medications, and treatment of bowel symptoms such as irritable bowel disease will be allowed.

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10 exclusion criteria prevent from participating
Lactation.

Use of hormonal contraception, selective estrogen receptor modulators, progestins, estrogens, steroids, or ovulation induction in the last 3 months.

Pregnancy.

Significant abnormalities in the physical or laboratory examination including renal and liver function more than twice the normal range.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

National Institutes of Health Clinical Center

Bethesda, United StatesOpen National Institutes of Health Clinical Center in Google Maps
CompletedOne Study Center