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.
Investigators
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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