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Clinical Trials/RBR-7jx2byj
RBR-7jx2byj
Completed
Phase 1

Treatment of Deeply infiltrative endometriosis with intravenous methotrexate carried in lipid core nanoparticles (LDE-ddMtx): a prospective pilot study

Faculdade de Medicina da Universidade de São Paulo - USP0 sitesJanuary 11, 2022

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Endometriosis
Sponsor
Faculdade de Medicina da Universidade de São Paulo - USP
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 11, 2022
End Date
April 2, 2021
Last Updated
2 years ago
Study Type
Intervention
Sex
Female

Investigators

Sponsor
Faculdade de Medicina da Universidade de São Paulo - USP

Eligibility 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

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

Outcomes

Primary Outcomes

Not specified

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