ENDO1000 - A UK-wide Endometriosis Research Project

January 8, 2026 updated by: University of Edinburgh

Approximately 1.5 million people in the UK, and 200 million globally live with endometriosis, and it is estimated to affect 1 in 10 women of reproductive age. Endometriosis is a chronic pain condition where the lining of the uterus (endometrium) grows in areas outside the uterus. This can cause patients a range of symptoms including severe pain, fatigue, irregular periods, infertility and gastrointestinal symptoms.

There is a clear unmet need for early diagnosis and more effective pain management for people who suffer from endometriosis. Endometriosis is a heterogeneous disease in terms of symptoms, trajectory, and indicated therapeutic course, which highlights the need to develop personalised/targeted approaches for effective longitudinal management which are acceptable and accessible to patients and their health care team.

The goal of this study is to accelerate discovery and advance data-driven research into endometriosis diagnosis and treatment by collecting large, multimodal, longitudinal data.

To achieve this goal, the investigators plan to deliver a longitudinal cohort study. Approximately 3000 UK individuals with endometriosis will be invited over a 24-month period to self-report symptoms that include, pain, menstrual cycle, painkiller use, sleep, exercise, diet and bowel habits via a bespoke ENDO1000 mobile app. A cohort of 1000 women will be asked to complete more in-depth questionnaires asking about endometriosis history, quality of life and treatments. This cohort of women will be asked to take self-collected biological samples (blood, urine, saliva, vaginal swab and faeces). The investigators will look at, for example, inflammatory markers, examine the microbiome and may look at DNA, with permission to see if there are any markers that can help with diagnosis or treatment of endometriosis. At the same time participants will be asked to wear a smartwatch which will monitor, for example, temperature, ambient light, sleep patterns and movement. All this will help the investigators to build a picture over time of the participant's endometriosis symptoms, treatments and what may cause symptoms to flare which in turn could lead to more patient led treatments.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

BACKGROUND Endometriosis is characterised by the presence of endometrial-like tissue ('lesions') outside the uterus, commonly on the lining of the pelvic cavity. It is a chronic, inflammatory gynaecological condition that affects approximately 6-10% of women and those assigned female at birth. It is associated with debilitating pelvic pain, gastrointestinal and urinary symptoms, fatigue and infertility. Endometriosis can profoundly affect quality of life, limiting daily activities, social engagement, physical and sexual health, relationships, career and educational pursuits, mental well-being, and overall health. It is associated with a 45% reduction in work productivity with an annual cost for caring for women with endometriosis estimated at > £8.2 billion per year in the UK.

People with endometriosis experience an average of 8 years of delay in the UK from the onset of their symptoms before receiving a diagnosis. There are no validated non-invasive tests for endometriosis and the current gold standard for diagnosis is via a diagnostic laparoscopy. Currently, the waiting time for this procedure in the UK is variable across NHS Trusts and can be up to two years.

Treatment options typically include:

  • Painkillers e.g. paracetamol, NSAIDs.
  • Surgery to remove endometriosis lesions, although this is ineffective in an estimated 30 % of women and, even when its effective, symptoms return in up to 50% of women within 5 years of surgery.
  • Hormone therapies, which are not curative, can have significant side effects and are contraceptive.

Some individuals explore lifestyle changes, such as dietary adjustments or exercise, but research on the effectiveness of these approaches remains limited.

RATIONALE FOR STUDY

Endometriosis is a heterogeneous disease in terms of symptoms, trajectory, and indicated therapeutic course, which highlights the need to develop personalised and targeted approaches for effective longitudinal management which are acceptable and accessible to patients and their health care team.

There is a clear unmet need for earlier diagnosis and more effective pain management for people who suffer from the condition.

The goal of this study is to accelerate discovery and advance data-driven research into endometriosis diagnosis and treatment by collecting large, multimodal, longitudinal data. This study is for the collection of data which will be retrospectively analysed. No feedback will be given to the individual participants on the results.

To achieve this goal, the investigators plan to deliver a longitudinal cohort Approximately 3000 UK individuals with endometriosis will be invited to take part in the study. participants will be asked to do the following over a 24-month period:

  1. Record information about their pain, physical functioning, mental health/emotional functioning, diet/sleep, medical/surgical interventions and self-management strategies on a bespoke smartphone app specifically developed for the needs of this project
  2. Wear smartwatches for up to four, six-week periods to collect raw actigraphy data (three-dimensional acceleration, wrist temperature, ambient light) from which we can objectively infer longitudinal physical activity, sleep, and circadian variability characteristics using algorithms we have developed in-house. The smartwatches will be posted to participants and include pre-paid envelopes for their return to the research team, following similar protocols we have already developed and successfully deployed at the University of Edinburgh in related longitudinal studies (e.g. the SHAW study, https://www.shaw.business-school.ed.ac.uk/).
  3. Obtain serial self-collected samples of saliva, blood, faeces and urine on up to four occasions. Sample collection kits will be sent to participants by our research team by post, self-collected at home and posted by participants back to our research team for analysis in our laboratory. This approach in collecting samples remotely will allow us to collect information from a diverse population of patients with endometriosis UK-wide and builds on our experience with longitudinal data collection.

The proposed study has been informed by those with lived experience of endometriosis and by representatives from the UK patient organisation, Endometriosis UK.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
      • Edinburgh, United Kingdom
        • Recruiting
        • University of Edinburgh
        • Contact:
          • Andrew Horne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Anyone living within the UK with a self-reported diagnosis of endometriosis

Description

INCLUSION CRITERIA

  1. Aged 16 or over
  2. Participants who confirm that they have received a clinical diagnosis of endometriosis (based on MRI, ultrasound or laparoscopy) within the last 10 years
  3. Living within the UK
  4. Willing and able to consent to installing and using the mobile ENDO1000 app on their smartphone or use our web-based equivalent.

EXCLUSION CRITERIA

  1. Pregnant
  2. Known severe coagulation disorder
  3. Known active Hepatitis B/C and/or HIV (due to Royal Mail restrictions on biospecimen postage)

Study Plan

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

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To generate a unique biomedical endometriosis resource with detailed clinical and lifestyle phenotyping.
Time Frame: 5 years

This study aims to characterise overall endometriosis symptom severity. This is a multifaceted objective to cover the breadth of symptoms of endometriosis and there is not a single scale that captures this that could be assigned as "primary outcome measure". We aim to define a new gold standard, on the basis of the largest longitudinal multimodal endometriosis study ever conducted. We envisage the resulting clinical score will be derived by combining different symptoms as experienced by patients and combining different data modalities.

Specifically, we will elicit responses where participants self-quantify: pain (EHP-30), fatigue (BFI), sleep problems (PSQI and PROMIS), bowel habits (NHS questionnaire), diet (FFQ), epidemiological and genetic data (WERF EPHect Patient Questionnaire).

Additional inputs will be provided by biological samples and data from a wrist-worn wearable sensor, from which we have validated algorithms to characterise physical activity, sleep and diurnal rhythm.
5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To use the biomedical endometriosis resource to address fundamental questions in our understanding of endometriosis.
Time Frame: 5 years

(i) To investigate the potential for patient stratification/prediction of treatment response from clinical/biological data profiles.

(ii) To investigate the relationship between symptoms of pelvic pain and the gut-brain axis (including microbiome) using multi-omics data.

(iii) To demonstrate longitudinal endometriosis symptom trajectories using app-based patient reported outcome measures (PROMs) and wearable technology.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Edinburgh

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Clinical Hospital Centre Zagreb
Endometriosis UK

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrew W Horne, PhD, MB ChB, University of Edinburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 5, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 101157146 (Other Grant/Funding Number: Horizon Europe)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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