Relugolix for Endometriosis Associated Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Patients with a diagnosis of endometriosis receiving treatment with Relugolix CT, according to clinical practice,.
- Who it may be relevant to
- Registry conditions: Endometriosis, Endometriosis-related Pain, Pelvic Pain Syndrome. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Ambispective, Single-center Observational Study Evaluating the Effectiveness of Relugolix Combination Therapy in Reducing Endometriosis-associated Pain Over 24 Weeks in a Real-world Clinical Setting
Overview
Endometriosis is a chronic, estrogen-dependent condition frequently associated with pelvic pain and reduced quality of life. Relugolix combination therapy (CT), an oral GnRH receptor antagonist-based treatment, has demonstrated efficacy in randomized clinical trials, but real-world data remain limited. The RELAX study is a single-center, ambispective observational study evaluating the effectiveness of relugolix CT in reducing endometriosis-associated pain over 24 weeks in routine clinical practice. The primary endpoint is the change from baseline in pelvic pain measured by the Visual Analog Scale (VAS). Secondary outcomes include changes in pain-related symptoms, ultrasonographic findings, patient satisfaction, and safety.
Detailed description
Endometriosis is a chronic, estrogen-dependent condition frequently associated with pelvic pain and impaired quality of life. Despite available hormonal treatments, unmet clinical needs remain in terms of long-term efficacy and tolerability. Relugolix combination therapy (CT), an oral GnRH receptor antagonist combined with estradiol and norethisterone acetate, has shown efficacy in randomized trials, but real-world data are limited.
The RELAX study is a single-center, ambispective observational study evaluating the effectiveness of relugolix CT in routine clinical practice. Women aged 18-50 years with laparoscopically or radiologically confirmed endometriosis receiving relugolix CT will be included. Both retrospective and prospective data will be collected.
The primary objective is to assess the change from baseline in chronic pelvic pain measured by the Visual Analog Scale (VAS) after 24 weeks of treatment. Secondary outcomes include changes in dyspareunia, dyschezia, and dysuria; the proportion of patients achieving ≥30% and ≥50% reduction in VAS pain score; changes in transvaginal ultrasound findings; patient satisfaction; and safety.
This study aims to provide real-world evidence to support clinical decision-making in the management of endometriosis-associated pain.
Interventions
- Other Patients with a diagnosis of endometriosis receiving treatment with Relugolix CT, according to clinical practice,
Collection of clinical, demographic, laboratory, instrumental, and treatment data. Data will be collected from the patients' medical records.
Primary outcome measures
- Evaluation of reduction of endometriosis associated pelvic pain [Time frame: 24 weeks]
Secondary outcome measures (4)
- Evaluation of reduction in other endometriosis-associated symptoms [Time frame: 24 weeks]
- Evaluation of reduction in VAS score [Time frame: 24 weeks]
- Changes in ultrasound findings. [Time frame: 24 weeks]
- Evaluation of patient satisfaction [Time frame: 24 weeks]
Eligibility criteria
Inclusion criteria
- Female aged between 18 and 50 years
- Endometriosis confirmed laparoscopically or radiologically (via ultrasound or MRI)
- Receiving treatment with Relugolix CT according to clinical practice for at least one month
- Pain score ≥40 on the VAS scale
- Regular menstrual cycles, (i.e., not in a menopausal or perimenopausal state)
- Signed informed consent
Exclusion criteria
\- Menopausal status (natural or surgical)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07440043 · 26987