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Minor9 versionsRe-verified since Sep 7, 2024, no change to tracked fieldsv81-v89
MinorStart date changed from estimate of Jul 8, 2024 to Jul 1, 2024v80
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MinorStart date: Jul 7, 2024 to Jul 8, 2024v79
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MinorStart date: May 13, 2024 to May 14, 2024v45
MinorStart date: May 12, 2024 to May 13, 2024v44
MinorStart 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Stopped: an ongoing trial was terminated, suspended or withdrawn.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....