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

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).

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria, Policlinico Sant'Orsola

Bologna, BO, 40138, Italy

Location status: Recruiting

Location contact

Alessandro Arena, MD

CONTACT

[email protected]

+390512144385

Alessandro Arena, MD

SUB_INVESTIGATOR

Renato Seracchioli, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

Time frame: 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).

Secondary outcomes

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

Time frame: 6 months

determine the rate of patients with endometriosis who were non-responsive to medical treatment at 6 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandro Arena

CONTACT

[email protected]

+390512144385

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2028
Study completion: 2029
First posted: May 14, 2024
Registry last updated: Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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