Endometriosis, Endometriosis-related Pain, Pelvic Pain Syndrome
Conditions
Brief 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. 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
OTHERPatients 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.
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of reduction of endometriosis associated pelvic pain | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of patient satisfaction | 24 weeks | 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. |
| Evaluation of reduction in other endometriosis-associated symptoms | 24 weeks | Change from baseline in dyspareunia, dyschezia, and dysuria after a 24-week treatment period with Relugolix CT. |
| Evaluation of reduction in VAS score | 24 weeks | The proportion of participants achieving ≥30% and ≥50% reduction in VAS pain score after 24 weeks of treatment compared with baseline. |
| Changes in ultrasound findings. | 24 weeks | Changes in findings from transvaginal ultrasound examinations. |
Contacts
CONTACTCristiano Rossitto
PRINCIPAL_INVESTIGATORCristiano Rossitto
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Outcome results
None listed