Recruiting

Observational Study

Sponsor:

National Institute of Environmental Health Sciences (NIEHS)

Code:

NCT06280807

Conditions

Hypogonadism

Hypergonadism

Precocious Puberty

Late Puberty

Amenorrhea

Eligibility Criteria

Sex: All

Age: 8 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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....

Conditions

Hypogonadism

Hypergonadism

Precocious Puberty

Late Puberty

Amenorrhea

Study ID

NCT06280807

Start date

Jul 1, 2024

Status verified date

Sep 24, 2026

Completion date

Mar 31, 2039

Anticipated

Primary completion date

Mar 28, 2039

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 70+

Healthy Volunteers: Not accepted

  • INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  • Male or female, referring to sex assigned at birth (cis gender)
  • Age >8 years and weight >=12 kg
  • A diagnosis of hypogonadism, infertility or other reproductive dysfunction

Some specific diagnoses (as defined in standard guidelines) will include:

  • Male or female hypogonadism

  • Obesity/metabolic syndrome related to hypogonadism.
  • Other reproductive dysfunction (e.g., secondary to endocrine dysfunction, thyroid disorders, Cushing syndrome, pharmacotherapy, etc.)
  • Premature Ovarian Insufficiency
  • Isolated hypogonadotropic hypogonadism
  • Polycystic Ovarian Syndrome
  • Delayed Puberty
  • Precocious puberty
  • Perimenopause and post-menopausal states
  • Androgen Excess States (Nonclassic Congenital Adrenal Hyperplasia, Extreme hyperinsulism, Idiopathic etc.)

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 informed consent document.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

  • A diagnosis of a serious medical disorder such as malignancy or heart disease will be grounds for exclusion at the discretion of the PI or AI.
  • Inability to follow up with the research study and/or perform study procedures, at the discretion of the PI or AI.
  • Pregnant participants, less than 18 years of age, for their safety, since there is not a trained doctor on the study to give proper medical care to pregnant individuals less than 18 years of age.

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:

  • Female, referring to sex assigned at birth (cis gender)
  • Age 40 - 62 years
  • Late perimenopausal or early postmenopausal status, defined by STRAW+10 criteria:
  • Late perimenopause (Stage -1): Amenorrhea >=60 days (2 cycles) in 12 months in the absence of other causes
  • Early postmenopause (Stage +1a/+1b): Amenorrhea >=12 months but <=2 years since final menstrual period (FMP)
  • History of regular menstrual cycles (consistent cycle length of 25 - 35 days) during the reproductive years (approximately 25-40 years of age), without medical intervention
  • Ability of participant to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

  • Previous surgery or procedure that induces amenorrhea or menopause

  • Prior hysterectomy (with ovarian conservation)
  • Prior bilateral oophorectomy
  • Prior endometrial ablation
  • Prior chemotherapy or pelvic radiation causing premature ovarian failure (unless age at menopause is clearly documented prior to intervention)
  • Current levonorgestrel-releasing intrauterine device (LNG-IUD)
  • 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.
  • Pregnant or breastfeeding
  • A diagnosis of a serious medical disorder such as malignancy or heart disease will be grounds for exclusion at the discretion of the PI or AI.
  • Inability to follow up with the research study and/or perform study procedures, at the discretion of the PI or AI.

Specific wash-out periods are required for evaluation of diagnosis or for exclusionary medications or supplements.

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Androgen Excess States- NOT Currently Recruiting[Recruitment may resume in the future.]

Polycystic Ovary Syndrome (PCOS); Women who meet criteria for PCOS based on NIH/ Rotterdam or other clinical criteria

Congenital Adrenal Hyperplasia - Currently Recruiting

Women with Congenital Adrenal Hyperplasia

Exhibiting signs of a diagnosis of hypogonadism- NOT Currently Recruiting

for example: Bosma arrhinia microphthalmia syndrome (BAMS)

Hyperandrogenism- NOT Currently Recruiting[Recruitment may resume in the future.]

Women who exhibit evidence of hyperandrogenism not related to Polycystic Ovarian Syndrome (PCOS); Extreme hyperinsulism, Idiopathic etc.

Hypogonadism / Infertility - NOT Currently Recruiting [Recruitment may resume in the future.]

Isolated hypogonadotropic hypogonadism

Hypothalamic Amenorrhea (female) Functional Hypogonadism (male) - NOT Currently Recruiting

Participants who experience secondary or primary amenorrhea, or male hypogonadism, in the setting of negative energy balance such dieting, eating disorders or exercise training

Miscellaneous - NOT Currently Recruiting[Recruitment may resume in the future.]

Reproductive disorders not related to the above categories. (e.g., secondary to endocrine dysfunction, thyroid disorders, Cushing syndrome, pharmacotherapy, etc.)

Perimenopause Menopause- Currently Recruiting[Recruitment may resume in the future.]

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.

Precocious or Delayed Puberty - NOT Currently Recruiting[Recruitment may resume in the future.]

Participants who display clinical evidence of delayed or precocious puberty based on standard criteria.

Premature Ovarian Insufficiency - NOT Currently Recruiting [Recruitment may resume in the future.]

Women who attain menopause before age 40 years (or as defined by clinical criteria).

Weight *Overweight/Underweight - NOT Currently Recruiting [Recruitment may resume in the future.]

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.

Primary outcome measure

  • Investigate the relationship between environment, lifestyle, and reproductive neuroendocrinology. [ Time Frame: at baseline and after clinical care for the underlying condition ]

Central Contacts and Locations

Central contacts

NIEHS Join A Study Recruitment Group

(855) 696-4347myniehs@nih.gov

Natalie D Shaw, M.D.

(984) 287-3716natalie.shaw@nih.gov

Locations

NIEHS Clinical Research Unit (CRU)

Recruiting

Research Triangle Park, North Carolina, United States, 27709

Contacts

NIH Clinical Center Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

NIEHS Join A Study Recruitment Group

(855) 696-4347myniehs@nih.gov

More Information

Sponsor

National Institute of Environmental Health Sciences (NIEHS)

Last update posted

Sep 28, 2026

Last verified

Sep 24, 2026

Keywords

  • Endocrine
  • Reproductive Disorders
  • Hypothalamic-Pituitary-Gonadal Endocrine Axis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by National Institute of Environmental Health Sciences (NIEHS) on 2026-09-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.