Endometriosis
Conditions
Interventions
The women participating in the study had deep intestinal endometriosis and complained of pain with a score greater than or equal to 7 on the visual analogue scale. They received one dose (3 participan
Sponsors
Faculdade de Medicina da Universidade de São Paulo - USP
Centro de Estudo e Pesquisa do Hospital Perola Byington
Eligibility
Sex/Gender
Female
Age
30 Years to 50 Years
Inclusion criteria
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
Exclusion criteria: Breastfeeding, any immunodeficiency, alcoholism, peptic ulcer, hepatic, renal or hematological disorders, active lung disease and known sensitivity to methotrexate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Brazil
Contacts
Public ContactRoberta Tavares
Outcome results
None listed