Risk Factors for Hormonal Therapy Failure in Patients With Endometriosis.

NCT06510647 | Recruiting

• 1 other identifier: ENDOFAIL-01
• Study Type: observational
• Target: 247
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of our study is to determine the percentage of patients with endometriosis who are non-responsive to medical therapy after 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 who are responsive to medical therapy (control group). The secondary objective of the study will be to determine the percentage of patients with endometriosis who are non-responsive to medical therapy after 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 who are responsive to medical therapy (control group).

Conditions

Endometriosis

Keywords

endometriosis; hormonal therapy; risk factors; therapy failure

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with endometriosis who are non-responsive to medical therapy after 12 months

  To determine the percentage of patients with endometriosis who are non-responsive to medical therapy after 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 who are responsive to medical therapy (control group).

  12 months

Secondary Outcomes (1)

• Percentage of patients with endometriosis who are non-responsive to medical therapy after 6 months

  6 months

Study Arms (2)

Group A

Patients with endometriosis who are non-responsive to medical therapy after 12 months

Other: Hormonal Therapy Agent

Group B

Patients with endometriosis who are responsive to medical therapy after 12 months

Other: Hormonal Therapy Agent

Interventions

Hormonal Therapy Agent OTHER

With an endometriosis diagnosis in which hormonal therapy is indicated, patients who satisfy inclusion and exclusion criteria will be administered scientifically validated questionnaires at the time of the visit (time 0): Endometriosis Health Profile-30 and the Short Form Health Survey SF-12. The second evaluation will be conducted 6 months later (time 1) along with a gynecological examination and gynecological ultrasound, and the same two questionnaires will be administered. Patients will be defined as non-responsive to medical therapy if their Endometriosis Health Profile 30 scores are equal to or higher at the "time 1" visit compared to the enrollment visit at "time 0". Patients will then be re-evaluated 12 months (time 2) after the first visit with the same criteria, and the two questionnaires will be administered once more. Similarly, patients with EHP-30 scores equal to or higher than the previous control at time 1 will be defined as non-responsive to medical therapy.

Group A; Group B

Eligibility Criteria

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

Study Population

Patients with a clinical and ultrasound diagnosis of endometriosis with an indication for hormonal therapy.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cagliari: lead

Study Sites (1)

Policlinico "Duilio-Casula"

Monserrato, Cagliari, 09042, Italy

RECRUITING

Related Publications (9)

• Dunselman GA, Vermeulen N, Becker C, Calhaz-Jorge C, D'Hooghe T, De Bie B, Heikinheimo O, Horne AW, Kiesel L, Nap A, Prentice A, Saridogan E, Soriano D, Nelen W; European Society of Human Reproduction and Embryology. ESHRE guideline: management of women with endometriosis. Hum Reprod. 2014 Mar;29(3):400-12. doi: 10.1093/humrep/det457. Epub 2014 Jan 15.

  PMID: 24435778 BACKGROUND

• Cornillie FJ, Oosterlynck D, Lauweryns JM, Koninckx PR. Deeply infiltrating pelvic endometriosis: histology and clinical significance. Fertil Steril. 1990 Jun;53(6):978-83. doi: 10.1016/s0015-0282(16)53570-5.

  PMID: 2140994 BACKGROUND

• Montanari G, Di Donato N, Benfenati A, Giovanardi G, Zannoni L, Vicenzi C, Solfrini S, Mignemi G, Villa G, Mabrouk M, Schioppa C, Venturoli S, Seracchioli R. Women with deep infiltrating endometriosis: sexual satisfaction, desire, orgasm, and pelvic problem interference with sex. J Sex Med. 2013 Jun;10(6):1559-66. doi: 10.1111/jsm.12133. Epub 2013 Apr 3.

  PMID: 23551753 BACKGROUND

• Seracchioli R, Poggioli G, Pierangeli F, Manuzzi L, Gualerzi B, Savelli L, Remorgida V, Mabrouk M, Venturoli S. Surgical outcome and long-term follow up after laparoscopic rectosigmoid resection in women with deep infiltrating endometriosis. BJOG. 2007 Jul;114(7):889-95. doi: 10.1111/j.1471-0528.2007.01363.x. Epub 2007 May 15.

  PMID: 17501958 BACKGROUND

• Stratton P, Khachikyan I, Sinaii N, Ortiz R, Shah J. Association of chronic pelvic pain and endometriosis with signs of sensitization and myofascial pain. Obstet Gynecol. 2015 Mar;125(3):719-728. doi: 10.1097/AOG.0000000000000663.

  PMID: 25730237 BACKGROUND

• Vercellini P, Buggio L, Somigliana E. Role of medical therapy in the management of deep rectovaginal endometriosis. Fertil Steril. 2017 Dec;108(6):913-930. doi: 10.1016/j.fertnstert.2017.08.038.

  PMID: 29202965 BACKGROUND

• Becker CM, Gattrell WT, Gude K, Singh SS. Reevaluating response and failure of medical treatment of endometriosis: a systematic review. Fertil Steril. 2017 Jul;108(1):125-136. doi: 10.1016/j.fertnstert.2017.05.004.

  PMID: 28668150 BACKGROUND

• Jones G, Kennedy S, Barnard A, Wong J, Jenkinson C. Development of an endometriosis quality-of-life instrument: The Endometriosis Health Profile-30. Obstet Gynecol. 2001 Aug;98(2):258-64. doi: 10.1016/s0029-7844(01)01433-8.

  PMID: 11506842 BACKGROUND

• Del Forno S, Mabrouk M, Arena A, Mattioli G, Giaquinto I, Paradisi R, Seracchioli R. Dienogest or Norethindrone acetate for the treatment of ovarian endometriomas: Can we avoid surgery? Eur J Obstet Gynecol Reprod Biol. 2019 Jul;238:120-124. doi: 10.1016/j.ejogrb.2019.04.010. Epub 2019 May 2.

  PMID: 31132690 BACKGROUND

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Stefano Angioni, PhD

CONTACT

07051093399; sangioni@yahoo.it

Salvatore Giovanni Vitale, PHD

CONTACT

3479354575; salvatoreg.vitale@unica.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Gynecology and Obstetrics

Study Record Dates

• First Submitted: July 14, 2024
• First Posted: July 19, 2024
• Study Start: February 26, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: July 19, 2024

Record last verified: 2024-07

Locations

IT (1)