An observational study in Hypogonadism, Hypergonadism and Precocious Puberty, sponsored by National Institute of Environmental Health Sciences (NIEHS). Recruiting at 1 site in United States. Open to participants aged 8 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by National Institute of Environmental Health Sciences (NIEHS) · Observational
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....
Study Description:
This study will investigate the relationship between environment, lifestyle, and reproductive function. This will include the study of these factors at enrollment and in response to clinical care for the underlying condition. This study will prospectively follow participants with endocrine reproductive disorders and collect research data, data secondary to clinical care and data regarding internal and external environmental exposures. We hypothesize that dysregulated environment is associated with reproductive and endocrine symptoms and dysfunction, and the clinical phenotype may evolve in response to treatment of the dysfunction.
Objectives:
Endpoints:
Since this is an exploratory and hypothesis generating study there are no pre-defined endpoints of this study.
320 studies on the registry are indexed under Hypogonadism; 39 are open to participants now.
This study's planned enrollment of 300 is above the median of 106 across 56 observational studies indexed under Hypogonadism.
Browse Hypogonadism studies →National Institute of Environmental Health Sciences (NIEHS) is the lead sponsor of 183 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult cisgender females, from the communities and surrounding areas of Durham, Chapel Hill and Raleigh in NC. - Currently Recruiting. Adult cisgender males and pediatric (between the ages of 8 and 18), cisgender male and females, from the communities and surrounding areas of Durham, Chapel Hill and Raleigh in NC - NOT currently recruiting. Recruitment may resume in the future. Not recruiting in Bethesda, Maryland. Recruitment may resume in the future.
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Some specific diagnoses (as defined in standard guidelines) will include:
Male or female hypogonadism
or
--Exhibiting signs of a diagnosis of hypogonadism, e.g., Bosma arrhinia microphthalmia syndrome (BAMS)
-Ability of participant, legal guardian, or Legally Authorized Representative (LAR) to understand and the willingness to sign a written document.
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
Individuals who do not meet the criteria for participation in this study (screen failure) because of an acute, reversible or transient medical reason may be rescreened upon reversal, improvement or stabilization of their clinical status. Participants who develop an acute, reversible or transient medical condition during the study may return upon reversal, improvement or stabilization of their clinical status.
MENOPAUSE COHORT INCLUSION AND EXCLUSION CRITERIA
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Previous surgery or procedure that induces amenorrhea or menopause
Specific are required for evaluation of diagnosis or for exclusionary medications or supplements.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Polycystic Ovary Syndrome (PCOS); Women who meet criteria for PCOS based on NIH/ Rotterdam or other clinical criteria
Women with Congenital Adrenal Hyperplasia
for example: Bosma arrhinia microphthalmia syndrome (BAMS)
Women who exhibit evidence of hyperandrogenism not related to Polycystic Ovarian Syndrome (PCOS); Extreme hyperinsulism, Idiopathic etc.
Isolated hypogonadotropic hypogonadism
Participants who experience secondary or primary amenorrhea, or male hypogonadism, in the setting of negative energy balance such dieting, eating disorders or exercise training
Reproductive disorders not related to the above categories. (e.g., secondary to endocrine dysfunction, thyroid disorders, Cushing syndrome, pharmacotherapy, etc.)
Perimenopausal women are those typically above age 40 years and experience secondary amenorrhea/ oligomenorrhea for two cycles ( at least 60 days ) in the last 12 months, as defined by the STRAW+10 criteria. Menopausal women have amenorrhea for at least 12 months.
Participants who display clinical evidence of delayed or precocious puberty based on standard criteria.
Women who attain menopause before age 40 years (or as defined by clinical criteria).
BMI below or above reference standard (Adult Reference: Asians/ Asian Americans- 18.5-22.9 kg/m2; Other races- 18.5-24.9 kg/m2. \*Participants may simultaneously belong to cohort of weight and any other cohort.
Investigate the relationship between environment, lifestyle, and reproductive neuroendocrinology.
We will analyze the correlation between internal exposures, and the longitudinal evolution of endocrine disorders. For instance, changes in PSQI (sleep) and DSM-5 (mood) questionnaire scores, research analytes and hormone metrics with treatment.
Time frame: at baseline and after clinical care for the underlying condition
the influence of behavioral and psychological factors on reproductive function
We will analyze the correlation between external exposures, and the longitudinal evolution of endocrine disorders. For instance, we will assess for changes in (stress), eating disorders and exposome information (derived from co-enrollment in the PEGS study) before and after treatment.
Time frame: at baseline and after clinical care for the underlying condition
the impact of stress on reproductive dysfunction
We will analyze the correlation between external exposures, and the longitudinal evolution of endocrine disorders. For instance, we will assess for changes in (stress), eating disorders and exposome information (derived from co-enrollment in the PEGS study) before and after treatment.
Time frame: at baseline and after clinical care for the underlying condition
the relationship between nutrition, diet and reproduction
We will analyze the correlation between external exposures, and the longitudinal evolution of endocrine disorders. For instance, we will assess for changes in (stress), eating disorders and exposome information (derived from co-enrollment in the PEGS study) before and after treatment.
Time frame: at baseline and after clinical care for the underlying condition
Greater exposure to EDCs will be associated with increased hot flash frequency in perimenopausal and menopausal women.
We will analyze the correlation between Endocrine Disrupting Chemicals in urine, blood, and wristband, exposome information (derived from co-enrollment in the PEGS study) and hot flash frequency.
Time frame: at baseline, month 2 and month 4
Plan to share: Yes — Aggregated and summarized data will be made available as part of associated publication, using NIH-Supported Data Sharing Resources (nlm.nih.gov/NIHbmic/generalist_repositories.html ). Aggregated summary and statistical analysis will be publicly available. All the patient-level data will require controlled access. Outside investigators may apply for research collaborations related to the original research questions, that will be IRB approved for use and a data transfer agreement will be signed, and coded, deidentified data will be provided with a data dictionary. For studies unrelated to the original research, only deidentified data can be provided and only when subjects consented to future research. Summary clinical response and adverse event data will be placed in clinicaltrials.gov one year after the final subject has completed the primary endpoint.
Supporting information: Study protocol, Informed consent form
Time frame: Data will be made available with the scientific publication upon reasonable request. In some cases, especially per journal policy and as appropriate, we will deposit deidentified data.
Access criteria: Aggregated summary and statistical analysis will be publicly available. All the patient-level data will require controlled access.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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