HypogonadismNCT06280807
Observation of Environment and Reproductive-Endocrine Effects
An observational study of Hypogonadism and Hypergonadism, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 99 years
- Conditions the study is for
- Hypogonadism, Hypergonadism, Precocious Puberty
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 31 Mar 2039
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Show all 25Show fewer
- 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.
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NIEHS Clinical Research Unit (CRU)
Research Triangle Park, North Carolina, 27709
NIH Clinical Center Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
NIEHS Join A Study Recruitment Group, (855) 696-4347, myniehs@nih.gov
About this study
Official title: OBServation of Environment and ReproductiVe Endocrine Effects Study (OBSERVE Study)
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.
Read more
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....
Read the detailed description
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:
- To study the hypothesis that external and internal environmental factors are associated with reproductive and endocrine symptoms and dysfunction
- To generate hypothesis for future studies investigating the impact of environment on human health
Endpoints:
Since this is an exploratory and hypothesis generating study there are no pre-defined endpoints of this study.
- Conditions
- Hypogonadism, Hypergonadism, Precocious Puberty, Late Puberty, Amenorrhea
- Keywords
- Endocrine, Reproductive Disorders, Hypothalamic-Pituitary-Gonadal Endocrine Axis
- Medical subject headings
- Hypogonadism, Puberty, Precocious, Amenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at baseline and after clinical care for the underlying condition
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at baseline, month 2 and month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Jul 2024
- Primary completion28 Mar 2039 (estimated)
- Study completion31 Mar 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HypogonadismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Natalie D Shaw, M.D., Principal investigator, National Institute of Environmental Health Sciences (NIEHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280807
- Sponsor's protocol ID
- 10001617
- Other IDs
- 001617-E
- Status last verified
- 24 Sep 2026
- First submitted
- 24 Feb 2024
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Moran LJ, Hutchison SK, Norman RJ, Teede HJ. Lifestyle changes in women with polycystic ovary syndrome. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD007506. doi: 10.1002/14651858.CD007506.pub3.
PubMed 21735412Sharma R, Biedenharn KR, Fedor JM, Agarwal A. Lifestyle factors and reproductive health: taking control of your fertility. Reprod Biol Endocrinol. 2013 Jul 16;11:66. doi: 10.1186/1477-7827-11-66.
PubMed 23870423Roychoudhury S, Chakraborty S, Choudhury AP, Das A, Jha NK, Slama P, Nath M, Massanyi P, Ruokolainen J, Kesari KK. Environmental Factors-Induced Oxidative Stress: Hormonal and Molecular Pathway Disruptions in Hypogonadism and Erectile Dysfunction. Antioxidants (Basel). 2021 May 24;10(6):837. doi: 10.3390/antiox10060837.
PubMed 34073826Corona G, Rastrelli G, Morelli A, Sarchielli E, Cipriani S, Vignozzi L, Maggi M. Treatment of Functional Hypogonadism Besides Pharmacological Substitution. World J Mens Health. 2020 Jul;38(3):256-270. doi: 10.5534/wjmh.190061. Epub 2019 Aug 29.
PubMed 31496147Gravholt CH, Chang S, Wallentin M, Fedder J, Moore P, Skakkebaek A. Klinefelter Syndrome: Integrating Genetics, Neuropsychology, and Endocrinology. Endocr Rev. 2018 Aug 1;39(4):389-423. doi: 10.1210/er.2017-00212.
PubMed 29438472
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OBServation of Environment and ReproductiVe Endocrine Effects Study (OBSERVE Study)
- ClinicalTrials.gov ID
- NCT06280807
- Acronym / sponsor ID
- 10001617
- Conditions
- Hypogonadism, Hypergonadism, Precocious Puberty, Late Puberty, Amenorrhea
- Keywords
- Endocrine, Reproductive Disorders, Hypothalamic-Pituitary-Gonadal Endocrine Axis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 28 Mar 2039 (estimated)
- Study completion
- 31 Mar 2039 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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....
Detailed description
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:
- To study the hypothesis that external and internal environmental factors are associated with reproductive and endocrine symptoms and dysfunction
- To generate hypothesis for future studies investigating the impact of environment on human health
Endpoints:
Since this is an exploratory and hypothesis generating study there are no pre-defined endpoints of this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 8 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (25 listed)
- 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
- Male or female hypogonadism
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Investigate the relationship between environment, lifestyle, and reproductive neuroendocrinology.
Time frame: at baseline and after clinical care for the underlying condition
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.
4 secondary outcomes
the influence of behavioral and psychological factors on reproductive function
Time frame: at baseline and after clinical care for the underlying condition
the impact of stress on reproductive dysfunction
Time frame: at baseline and after clinical care for the underlying condition
the relationship between nutrition, diet and reproduction
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.
Time frame: at baseline, month 2 and month 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Background: PubMed 21735412Moran LJ, Hutchison SK, Norman RJ, Teede HJ. Lifestyle changes in women with polycystic ovary syndrome. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD007506. doi: 10.1002/14651858.CD007506.pub3.
- Background: PubMed 23870423Sharma R, Biedenharn KR, Fedor JM, Agarwal A. Lifestyle factors and reproductive health: taking control of your fertility. Reprod Biol Endocrinol. 2013 Jul 16;11:66. doi: 10.1186/1477-7827-11-66.
- Background: PubMed 34073826Roychoudhury S, Chakraborty S, Choudhury AP, Das A, Jha NK, Slama P, Nath M, Massanyi P, Ruokolainen J, Kesari KK. Environmental Factors-Induced Oxidative Stress: Hormonal and Molecular Pathway Disruptions in Hypogonadism and Erectile Dysfunction. Antioxidants (Basel). 2021 May 24;10(6):837. doi: 10.3390/antiox10060837.
- Background: PubMed 31496147Corona G, Rastrelli G, Morelli A, Sarchielli E, Cipriani S, Vignozzi L, Maggi M. Treatment of Functional Hypogonadism Besides Pharmacological Substitution. World J Mens Health. 2020 Jul;38(3):256-270. doi: 10.5534/wjmh.190061. Epub 2019 Aug 29.
- Background: PubMed 29438472Gravholt CH, Chang S, Wallentin M, Fedder J, Moore P, Skakkebaek A. Klinefelter Syndrome: Integrating Genetics, Neuropsychology, and Endocrinology. Endocr Rev. 2018 Aug 1;39(4):389-423. doi: 10.1210/er.2017-00212.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Natalie D Shaw, M.D. principal investigator
National Institute of Environmental Health Sciences (NIEHS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypogonadism and Hypergonadism, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact NIEHS Join A Study Recruitment Group ((855) 696-4347, myniehs@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigate the relationship between environment, lifestyle, and reproductive neuroendocrinology. (time frame: at baseline and after clinical care for the underlying condition). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06280807, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.