EndometriosisRELAXNCT07440043
Relugolix for Endometriosis Associated Pain
An observational study of Endometriosis and Endometriosis-related Pain, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis, Endometriosis-related Pain, Pelvic Pain Syndrome
- What is being tested?
- Patients with a diagnosis of endometriosis receiving treatment with Relugolix CT, according to clinical practice,
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 25 Feb 2026to 28 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients with a diagnosis of endometriosis who have been receiving treatment with Relugolix CT according to clinical practice for at least one month.
Who may be able to join
- 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
Who cannot join
- Menopausal status (natural or surgical)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Being tested
- Patients with a diagnosis of endometriosis receiving treatment with Relugolix CT, according to clinical practice,
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with a diagnosis of endometriosis receiving treatment with Relugolix CT, according to clinical practice,Other
Collection of clinical, demographic, laboratory, instrumental, and treatment data. Data will be collected from the patients' medical records.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of reduction of endometriosis associated pelvic pain
To evaluate the reduction of endometriosis-associated pain after a 24-week treatment period with Relugolix CT used according to current clinical practice.
Measured: 24 weeks
Secondary outcomes (4)
Evaluation of reduction in other endometriosis-associated symptoms
Change from baseline in dyspareunia, dyschezia, and dysuria after a 24-week treatment period with Relugolix CT.
Measured: 24 weeks
Evaluation of reduction in VAS score
The proportion of participants achieving ≥30% and ≥50% reduction in VAS pain score after 24 weeks of treatment compared with baseline.
Measured: 24 weeks
Changes in ultrasound findings.
Changes in findings from transvaginal ultrasound examinations.
Measured: 24 weeks
Evaluation of patient satisfaction
Patient satisfaction with treatment, assessed using a five-category scale (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied) administered at the end of the 24-week period.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start25 Feb 2026 (estimated)
- Primary completion25 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cristiano Rossitto, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07440043
- Sponsor's protocol ID
- 26987
- Acronym
- RELAX
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07440043
- Acronym / sponsor ID
- RELAX / 26987
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 25 Feb 2026 (estimated)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with a diagnosis of endometriosis who have been receiving treatment with Relugolix CT according to clinical practice for at least one month.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (1 listed)
- Menopausal status (natural or surgical)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | – |
Primary outcome
Evaluation of reduction of endometriosis associated pelvic pain
Time frame: 24 weeks
To evaluate the reduction of endometriosis-associated pain after a 24-week treatment period with Relugolix CT used according to current clinical practice.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cristiano Rossitto principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Endometriosis-related Pain, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cristiano Rossitto (+390630155701, cristiano.rossitto@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of reduction of endometriosis associated pelvic pain (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.