Treatment of Endometriosis using the drug methotrexate associated with lipid substances that facilitate the action of medication at the site of the disease

Phase 1

• Conditions: Endometriosis; Pelvic Pain; Dysmenorrhea; Dyspareunia; SP2.006.022

• Registration Number: RBR-7jx2byj
• Lead Sponsor: Faculdade de Medicina da Universidade de São Paulo - USP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-04-02
• Study Start: 2022-01-11
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Data analysis completed
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

We included women in the reproductive period between 30 and 50 years, with no future intention of pregnancy; DIE affecting at least the inner muscular intestinal layer; with at least one pelvic pain symptom (dysmenorrhea, deep dyspareunia, chronic pelvic pain, dyschezia and/or dysuria during the menstrual period) with a score of 7 or higher on the visual analogue scale (VAS) (Maxwell et al., 1978), with no current use of hormone therapy including gonadotropin-releasing hormone (GnRH) analogs or progestogens for at least six months prior to the beginning of the study or no use of combined hormonal contraceptives for three months prior to medication of the present study or still use of any hormonal therapy and maintain complaints of significative pain (VAS equal or higher than 7); and no pregnancy.

Exclusion Criteria

Breastfeeding, any immunodeficiency, alcoholism, peptic ulcer, hepatic, renal or hematological disorders, active lung disease and known sensitivity to methotrexate

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Outcome found 1: There was a significant improvement in the complaint of dyspareunia, acyclic pelvic pain and dyschezia over 180 days, with the use of the medication methotrexate coupled with LDE lipid nanoemulsion (LDE-MTX);Expected outcome 1: Assess whether there was improvement in pelvic pain (dysmenorrhea, acyclic pelvic pain, depth dyspareunia, dyschezia and dysuria) in patients with deep intestinal endometriosis assessed by the Visual Analog Pain Scale. Outcomes will be analyzed according to drug dose and follow-up time.

Secondary Outcome Measures

Name	Time	Method
Expected outcome 2: Evaluate the presence of side effects and toxicity with the use of the drug methotrexate coupled with lipid nanoemulsion LDE (LDE-MTX);Outcome found 2: There were no serious adverse events, as well as no signs of myelotoxicity or liver or kidney toxicity, after administration of the drug methotrexate coupled with lipid nanoemulsion LDE (LDE-MTX);Expected outcome 3: Evaluate the reduction of pelvic and intestinal endometriosis lesions after the use of methotrexate coupled to LDE lipid nanoemulsion (LDE-MTX), evaluated through transvaginal ultrasound with bowel preparation.;Outcome found 3: There was no significant change in the size of intestinal endometriotic lesions on transvaginal ultrasound with bowel preparation, nor of other pelvic lesions related to endometriosis, after administration of the medication methotrexate coupled with LDE lipid nanoemulsion (LDE-MTX)