Hypogonadism Clinical Trial
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. Objective: To learn how environmental factors may affect the endocrine and reproductive systems. 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. ...
Status | Recruiting |
Enrollment | 300 |
Est. completion date | March 31, 2039 |
Est. primary completion date | March 28, 2039 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 99 Years |
Eligibility | - INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Male or female, referring to sex assigned at birth (cis gender) 2. Age > 8 years and weight >= 12 kg 3. 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) 4. 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: 1. 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. 2. Inability to follow up with the research study and/or perform study procedures, at the discretion of the PI or AI. 3. 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. |
Country | Name | City | State |
---|---|---|---|
United States | NIEHS Clinical Research Unit (CRU) | Research Triangle Park | North Carolina |
Lead Sponsor | Collaborator |
---|---|
National Institute of Environmental Health Sciences (NIEHS) |
United States,
Corona 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. — View Citation
Gravholt 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. — View Citation
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. — View Citation
Roychoudhury 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. — View Citation
Sharma 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | at baseline and after clinical care for the underlying condition | |
Secondary | 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. | at baseline and after clinical care for the underlying condition | |
Secondary | 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. | at baseline and after clinical care for the underlying condition | |
Secondary | 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. | at baseline and after clinical care for the underlying condition |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03126656 -
Effects of Testosterone on Myocardial Repolarization
|
Phase 4 | |
Withdrawn |
NCT02137265 -
Assessing the Efficacy of Clomiphene Citrate in Patients With Azoospermia and Hypoandrogenism
|
N/A | |
Terminated |
NCT02419105 -
Effects of Transdermal Testosterone and/or Monthly Vitamin D on Fall Risk in Pre--frail Hypogonadal Seniors
|
Phase 3 | |
Completed |
NCT02222558 -
Oral Testosterone for the Treatment of Hypogonadism in Males
|
Phase 2 | |
Completed |
NCT02233751 -
Pharmacokinetic Study of Subcutaneous Testosterone Enanthate
|
Phase 1 | |
Completed |
NCT01887418 -
Pharmacokinetic Study of Testosterone Enanthate
|
Phase 1/Phase 2 | |
Terminated |
NCT01092858 -
NEBIDO in Symptomatic Late Onset Hypogonadism (SLOH)
|
Phase 4 | |
Completed |
NCT00624624 -
Follow-up of Serum Androgen Profile After Bariatric Surgery in Men With Obesity Related Hypogonadotropic Hypogonadism
|
N/A | |
Completed |
NCT00752869 -
Efficacy Study for Use of Dutasteride (Avodart) With Testosterone Replacement
|
Phase 4 | |
Completed |
NCT00613288 -
Testosterone and Lipolysis, Insulin Sensitivity and Protein Metabolism
|
N/A | |
Completed |
NCT00838838 -
Efficacy of Nebido on Bone Mineral Density (BMD) in Hypogonadal Paraplegic Patients With Confirmed Osteoporosis
|
N/A | |
Completed |
NCT00119483 -
Older Men and Testosterone
|
N/A | |
Completed |
NCT00004438 -
Leuprolide in Treating Adults With Hypogonadotropism
|
N/A | |
Withdrawn |
NCT00398034 -
Analgesic Efficacy of Testosterone Replacement in Hypogonadal Opioid-treated Chronic Pain Patients: A Pilot Study.
|
Phase 2 | |
Completed |
NCT02937740 -
Open-Label Study, Evaluating Patient Satisfaction and Symptom Improvement When Treating Male Hypogonadism With Natestoâ„¢
|
Phase 4 | |
Completed |
NCT02921386 -
The Effect of Various Amounts of Fat on PK of Oral Testosterone Undecanoate
|
Phase 2 | |
Completed |
NCT01717768 -
Oral Testosterone for the Treatment of Hypogonadism
|
Phase 2 | |
Terminated |
NCT01460654 -
Testosterone and Alendronate in Hypogonadal Men
|
Phase 2 | |
Completed |
NCT00998933 -
Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure
|
Phase 1 | |
Completed |
NCT00857454 -
A Trial to Evaluate the Ongoing Skin Safety of Testosterone MD-Lotion Formulations
|
Phase 3 |