Risk Factors for Non-response to Hormonal Medical Therapy in Patients With Endometriosis

NCT06413381 | Recruiting

• 1 other identifier: ENDOFAIL - 01
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Determine the proportion of patients with endometriosis unresponsive to medical therapy and to compare the clinical and ultrasonographic characteristics of this group of patients (study group) with the clinical and ultrasonographic characteristics of patients responsive to medical therapy (control group).

Conditions

Endometriosis

Keywords

pelvic pain; endometriosis; hormone therapy; therapeutic non-response; risk factors; reproduction; infertility

Outcome Measures

Primary Outcomes (1)

• Rate of patients with endometriosis non-responsive to medical treatment at 12 months

  determine the rate of patients with endometriosis who were non-responsive to medical treatment at 12 months and to compare the clinical and ultrasound characteristics of this group of patients (study group) with the clinical and ultrasound characteristics of patients responsive to medical treatment (control group).

  12 months

Secondary Outcomes (1)

• Rate of patients with endometriosis non-responsive to medical treatment at 6 months

  6 months

Study Arms (2)

Focus group

non-responsive patients to medical treatment

Control group

responsive patients to medical treatment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients with clinical and ultrasound diagnosis of endometriosis with indication for administration of hormone therapy

You may qualify if:

• age between 18 and 50 years;
• patients with endometriosis-related pain symptoms (dyspareunia, dyschezia, dysmenorrhea, chronic pelvic pain, dysuria, periovulatory pain, with at least one of these symptoms presenting Numerical Pain Rating Scale intensity \> 5);
• indication for administration of oral hormonal medical treatment for endometriosis;
• acquisition of informed consent.

You may not qualify if:

• patients with contraindications to oral hormone treatment
• current or previous pelvic infections
• history of malignancy or current suspicion of gynecologic malignant lesions
• previous pelvic surgery (hysterectomy, salpingectomy, ovarian cyst removal, myomectomy, surgery for endometriosis, bowel resections)
• positive history of other causes of chronic pelvic pain
• post-menopausal status

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria, Policlinico Sant'Orsola

Bologna, BO, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Endometriosis; Pelvic Pain; Infertility

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Alessandro Arena

CONTACT

+390512144385; alessandro.arena6@unibo.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 14, 2024
• Study Start: April 19, 2024
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): November 28, 2029
• Last Updated: August 1, 2024

Record last verified: 2024-03

Locations

IT (1)