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Observation of Environment and Reproductive-Endocrine Effects

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 92 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor Trial arms changed: 9 → 11
    • Secondary endpoints: 3 to 4
  2. Minor New version filed on ClinicalTrials.gov
  3. Minor New version filed on ClinicalTrials.gov
  4. Minor 9 versions Re-verified since Sep 7, 2024, no change to tracked fieldsv81-v89
  5. Minor Start date changed from estimate of Jul 8, 2024 to Jul 1, 2024v80
Show 37 earlier versionsHide 37 earlier versions
  1. Minor Start date: Jul 7, 2024 to Jul 8, 2024v79
  2. Minor Start date: Jul 4, 2024 to Jul 7, 2024v78
  3. Minor Start date: Jul 3, 2024 to Jul 4, 2024v77
  4. Minor Start date: Jul 2, 2024 to Jul 3, 2024v76
  5. Minor Start date: Jul 1, 2024 to Jul 2, 2024v75
  6. Minor Start date: Jun 30, 2024 to Jul 1, 2024v74
  7. Minor Start date: Jun 27, 2024 to Jun 30, 2024v73
  8. Minor Start date: Jun 26, 2024 to Jun 27, 2024v72
  9. Minor Start date: Jun 23, 2024 to Jun 26, 2024v71
  10. Minor Start date: Jun 20, 2024 to Jun 23, 2024v70
  11. Minor Start date: Jun 19, 2024 to Jun 20, 2024v69
  12. Minor Start date: Jun 18, 2024 to Jun 19, 2024v68
  13. Minor Start date: Jun 17, 2024 to Jun 18, 2024v67
  14. Minor Start date: Jun 16, 2024 to Jun 17, 2024v66
  15. Minor Start date: Jun 13, 2024 to Jun 16, 2024v65
  16. Minor Start date: Jun 12, 2024 to Jun 13, 2024v64
  17. Minor Start date: Jun 11, 2024 to Jun 12, 2024v63
  18. Minor Start date: Jun 10, 2024 to Jun 11, 2024v62
  19. Minor Start date: Jun 9, 2024 to Jun 10, 2024v61
  20. Minor Start date: Jun 6, 2024 to Jun 9, 2024v60
  21. Minor Start date: Jun 5, 2024 to Jun 6, 2024v59
  22. Minor Start date: Jun 4, 2024 to Jun 5, 2024v58
  23. Minor Start date: Jun 3, 2024 to Jun 4, 2024v57
  24. Minor Start date: May 30, 2024 to Jun 3, 2024v56
  25. Minor Start date: May 29, 2024 to May 30, 2024v55
  26. Minor Start date: May 28, 2024 to May 29, 2024v54
  27. Minor Start date: May 26, 2024 to May 28, 2024v53
  28. Minor Start date: May 23, 2024 to May 26, 2024v52
  29. Minor Start date: May 21, 2024 to May 23, 2024v51
  30. Minor Start date: May 20, 2024 to May 21, 2024v50
  31. Minor Start date: May 19, 2024 to May 20, 2024v49
  32. Minor Start date: May 16, 2024 to May 19, 2024v48
  33. Minor Start date: May 15, 2024 to May 16, 2024v47
  34. Minor Start date: May 14, 2024 to May 15, 2024v46
  35. Minor Start date: May 13, 2024 to May 14, 2024v45
  36. Minor Start date: May 12, 2024 to May 13, 2024v44
  37. Minor Start date: May 9, 2024 to May 12, 2024v43
  • 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: Endocrine disorders occur when the glands that make hormones do not work properly. Hormones levels that are too high or too low can cause problems such as late or early puberty, irregular periods, and infertility. Environmental factors - including pollution; chemical exposure at home and work; foods; medicines; and sleep habits - may cause problems with the endocrine and reproductive systems. Objective: To learn how environmental factors may affect the endocrine and reproductive systems. Reproductive Disorder Cohorts: Eligibility: Males or females, referring to sex assigned at birth, aged 8 years and older; they must have hypogonadism, infertility, or other reproductive disorders. Design: Adult participants will have 4 to 5 visits in 5 years. Children may have up to 12 visits; they may remain in the study up to the age of 23. Most visits will be less than 3 hours. Participants will be screened. They will have a physical exam. They will have blood and urine tests. They will complete questionnaires; they will answer questions about their diet, health, and other topics. Some may be referred for additional tests, such as imaging scans and semen analysis. Specific tests conducted during study visits will vary, depending on the participant s diagnosis. In addition to repeated blood and urine tests, these may include: Body composition measure: Participants will sit in a pod-shaped machine for about 6 minutes. The machines measures the air inside the capsule to record body fat and breathing volume. Resting energy expenditure test: Participants will lie down with a clear dome placed over their head. They will breathe quietly for 30 minutes. This test measures the number of calories their body burns at rest. Menopausal Women Cohort: Eligibility: Inclusion criteria: Females, ages 40-62, in late perimenopause (skipped at least 2 menstrual periods) or early post menopause (last menstrual period within 2 years), with a history of regular menstrual cycles during reproductive years. Exclusion Criteria: Previous surgery or procedure that induces amenorrhea or menopause, diagnosis of reproductive disorder, symptoms of irregular menstrual cycles, or medication or device use (eg, birth control pills) that would prevent the determination of menopausal status. Design: Women will have one study visit, and three at home specimen collections: Study visit, At home collections Day 7, Month 2 and Month 4. At the study visit, women will be screened, complete questionnaires, provide blood and urine for lab testing for hormones and chemical exposures, and a Body composition measure. Women will collect first morning void before their study visit, Month 2 and Month 4. A wristband (for chemical exposures) is worn from the study visit for 7 Days. Women will complete questionnaires during at home collections at Day 7, Month 2 and Month 4....
Trial Details
NCT Number NCT06280807
Lead Sponsor National Institute of Environmental Health Sciences (NIEHS)
Conditions
(from sponsor)
Hypogonadism, Hypergonadism, Precocious Puberty, Late Puberty, Amenorrhea
Related terms Amenorrhea, Hypogonadism, Puberty, Precocious
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov