Identifying risk factors for hormonal therapy failure in endometriosis patients
Risk Factors for Hormonal Therapy Failure in Patients With Endometriosis.
University of Cagliari · NCT06510647
This study is trying to find out why some women with endometriosis don't get better with hormonal therapy after 6 and 12 months, by looking at their symptoms and ultrasound results.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 247 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | University of Cagliari (other) |
| Locations | 1 site (Monserrato, Cagliari) |
| Trial ID | NCT06510647 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the percentage of endometriosis patients who do not respond to hormonal therapy after 6 and 12 months. It will compare the clinical and ultrasound characteristics of non-responsive patients with those who respond to treatment. The study will involve patients aged 18 to 50 years with painful endometriosis symptoms and will be conducted across multiple centers. Participants will undergo gynecological examinations and ultrasounds to confirm their diagnosis and eligibility.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 50 with a clinical diagnosis of endometriosis and significant painful symptoms requiring hormonal therapy.
Not a fit: Patients with contraindications to hormonal therapy, a history of malignancy, or those who are postmenopausal may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify risk factors for hormonal therapy failure, leading to more effective treatment strategies for endometriosis patients.
How similar studies have performed: While there have been studies on endometriosis treatment responses, this specific observational approach focusing on risk factors for therapy failure is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 50 years; * Patients with painful symptoms related to endometriosis (dyspareunia, dyschezia, dysmenorrhea, chronic pelvic pain, dysuria, periovulatory pain, with at least one of these symptoms presenting a Numerical Pain Rating Scale intensity \> 5); * Indication for the administration of oral hormonal medical therapy for endometriosis; * Acquisition of informed consent. Exclusion Criteria: * Patients with contraindications to oral hormonal therapy; * Current or past pelvic infections; * History of malignancy or current suspicion of malignant gynecological lesions; * Previous pelvic surgery (hysterectomy, salpingectomy, ovarian cyst removal, myomectomy, surgery for endometriosis, intestinal resections); * Positive history for other causes of chronic pelvic pain; * Postmenopausal status.
Where this trial is running
Monserrato, Cagliari
- Policlinico "Duilio-Casula" — Monserrato, Cagliari, Italy (RECRUITING)
Study contacts
- Study coordinator: Stefano Angioni, PhD
- Email: sangioni@yahoo.it
- Phone: 07051093399
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Endometriosis, endometriosis, hormonal therapy, risk factors, therapy failure