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Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 141 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor Re-verified, no change to tracked fields
  2. Minor New version filed on ClinicalTrials.gov
  3. Minor 10 versions Re-verified since Mar 31, 2026, no change to tracked fieldsv130-v139
  4. Notable Primary and study completion dates: May 31, 2026 to May 31, 2027v129
  5. Notable Primary completion date: May 31, 2025 to May 31, 2026v128
Show 36 earlier versionsHide 36 earlier versions
  1. Minor Study completion date: May 31, 2025 to May 31, 2026v127
  2. Minor Re-verified, no change to tracked fieldsv126
  3. Notable Primary and study completion dates: May 31, 2024 to May 31, 2025v125
  4. Minor 3 versions Re-verified since Oct 24, 2023, no change to tracked fieldsv122-v124
  5. Notable Primary and study completion dates: May 31, 2023 to May 31, 2024v121
  6. Minor Start date changed from estimate of Apr 6, 2023 to Mar 3, 2023v120
  7. Minor Re-verified, no change to tracked fieldsv119
  8. Minor Start date: Apr 4, 2023 to Apr 6, 2023v118
  9. Minor Start date: Apr 3, 2023 to Apr 4, 2023v117
  10. Minor Start date: Mar 31, 2023 to Apr 3, 2023v116
  11. Minor Start date: Mar 30, 2023 to Mar 31, 2023v115
  12. Minor Start date: Mar 28, 2023 to Mar 30, 2023v114
  13. Minor Start date: Mar 27, 2023 to Mar 28, 2023v113
  14. Minor Start date: Mar 24, 2023 to Mar 27, 2023v112
  15. Minor Start date: Mar 22, 2023 to Mar 24, 2023v111
  16. Minor Start date: Mar 21, 2023 to Mar 22, 2023v110
  17. Minor Start date: Mar 20, 2023 to Mar 21, 2023v109
  18. Minor Start date: Mar 19, 2023 to Mar 20, 2023v108
  19. Minor Start date: Mar 16, 2023 to Mar 19, 2023v107
  20. Minor Start date: Mar 15, 2023 to Mar 16, 2023v106
  21. Minor Start date: Mar 14, 2023 to Mar 15, 2023v105
  22. Minor Start date: Mar 13, 2023 to Mar 14, 2023v104
  23. Minor Start date: Mar 12, 2023 to Mar 13, 2023v103
  24. Minor Start date: Mar 9, 2023 to Mar 12, 2023v102
  25. Minor Start date: Mar 8, 2023 to Mar 9, 2023v101
  26. Minor Start date: Mar 7, 2023 to Mar 8, 2023v100
  27. Minor Start date: Mar 6, 2023 to Mar 7, 2023v99
  28. Minor Start date: Mar 5, 2023 to Mar 6, 2023v98
  29. Minor Start date: Mar 2, 2023 to Mar 5, 2023v97
  30. Minor Start date: Feb 28, 2023 to Mar 2, 2023v96
  31. Minor Start date: Feb 24, 2023 to Feb 28, 2023v95
  32. Minor Start date: Feb 23, 2023 to Feb 24, 2023v94
  33. Minor Start date: Feb 22, 2023 to Feb 23, 2023v93
  34. Minor Start date: Feb 21, 2023 to Feb 22, 2023v92
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05567198
Lead Sponsor National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions
(from sponsor)
Systemic Lupus Erythematosus (Sle), Primary Ovarian Insufficiency (Poi)
Related terms Lupus Erythematosus, Systemic, Nephritis, Primary Ovarian Insufficiency
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov