Condition: Systemic Lupus Erythematosus (Sle) · Primary Ovarian Insufficiency (Poi) · Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Background: Systemic lupus erythematosus (SLE) is a disease that affects females nine times more often than males. People with SLE are often treated with cyclophosphamide (CYC). But CYC can damage a woman s ovaries; it may cause infertility. A drug called GnRHa is sometimes given to protect the ovaries during CYC therapy. But no one really knows how effective GnRHa treatment is. This natural history survey will compare women who received GnRHa during CYC therapy with those who did not. Objective: To find out whether GnRHa can help protect women s ovaries during CYC. Eligibility: Women under age 40 years starting CYC treatment with or without GnRHa. Design: This study will do 2 things: It will conduct patient surveys. It will collect data from medical records. Participants will complete a one-time survey. They will answer questions about their menstrual cycle. They will be asked about their history of pregnancy or infertility. Participants can take the survey in 4 ways: On paper, sent through the mail. Online, in a secure web page managed by the NIH. By phone. In person, during a routine visit to the NIH clinic. The survey will take about 30 minutes. Participants medical records will be reviewed. Researchers will look for data about the participants SLE disease. This may include their symptoms and the results of their blood tests. It may also include the details of prior treatments. Researchers will also collect data about participants reproductive history. Thi…
This description comes directly from the study's public registry record.
Sarfaraz A Hasni, M.D. · (301) 451-1599 · hasnisa@mail.nih.gov
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| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Bethesda, Maryland, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05567198