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NCT05567198 · ClinicalTrials.gov registry record
Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires
A clinical trial of Systemic Lupus Erythematosus (SLE) and Primary Ovarian Insufficiency (Poi), sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- Recruiting
- Registry status
- 100
- Enrollment target
- 1
- Study location
NCT05567198 is a study of Systemic Lupus Erythematosus (SLE) and Primary Ovarian Insufficiency (Poi) that is actively recruiting participants, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The registered enrollment target is 100 participants, below the 1,058-participant average among 14 other Systemic Lupus Erythematosus (SLE) trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05567198, a study of Systemic Lupus Erythematosus (SLE) and Primary Ovarian Insufficiency (Poi), is actively recruiting participants, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- RECRUITING
- Registry status
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
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. This may include their personal or family history of infertility. It may include any fertility treatments and any sexually transmitted infections.
Conditions Studied
Study Locations (1)
Maryland
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2023-03-03 |
| Est. Completion | 2026-05-31 |
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)93 total trials
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05567198
The ClinicalTrials.gov registry entry for NCT05567198 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,058-participant average among 14 other Systemic Lupus Erythematosus (SLE) trials with a reported enrollment target (91% lower). The listed sponsor is National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Systemic Lupus Erythematosus (SLE) appearing as the primary indexed condition, and to 0 interventions.
NCT05567198 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT05567198 about?
NCT05567198 is a clinical study titled "Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires". 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 ova...
What is the current status of trial NCT05567198?
This trial is currently recruiting. The enrollment target is 100 participants. The study started on 2023-03-03. Estimated completion is 2026-05-31.
What conditions does trial NCT05567198 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus (SLE), Primary Ovarian Insufficiency (Poi).
Who is sponsoring clinical trial NCT05567198?
This trial is sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05567198 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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