Last reviewed · How we verify
NCT01511588
Hormonal Regulation of Puberty and Fertility
trial in Endocrine Disease in 111 participants. Completed.
Quick facts
| Lead sponsor | National Institute of Environmental Health Sciences (NIEHS) |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 111 |
| Start date | 25 April 2012 |
| Sites | 2 locations across United States |
Conditions studied
- Endocrine Disease — all drugs for Endocrine Disease →
- Infertility — all drugs for Infertility →
- Hypogonadism — all drugs for Hypogonadism →
- Amenorrhea — all drugs for Amenorrhea →
Sponsor
National Institute of Environmental Health Sciences (NIEHS)
Who can join
14 and older, any sex, with Endocrine Disease or Infertility. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: \- The body produces gonadotropin-releasing hormone (GnRH) about every 2 hours. GnRH travels through the bloodstream to the pituitary gland, where it stimulates the gland to produce hormones called gonadotropins. These hormones stimulate the testicles or ovaries. The testicles produce testosterone and develop sperm. The ovaries produce estrogen and prepare for ovulation. Normal estrogen and testosterone levels are required for puberty. Some people, however, have either low levels or total lack of GnRH. This can cause problems with puberty and fertility. Researchers want to study people with low or no GnRH to better understand how it affects puberty and fertility. Objectives: \- To study disorders of GnRH production. Eligibility: * Adult men and women at least 18 years of age with low or no gonadotropin levels. * Adolescents between 14 and 18 years of age with low or no gonadotropin levels. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. * Participants will have tests to look at their hormone levels. Blood samples may be collected after taking different drugs, including insulin and cortisone. A 24-hour urine sample will be collected. * Participants will have imaging studies to look at bone and brain development. They will also have ultrasounds of the kidneys, abdomen, and reproductive organs. * Tests of smell and hearing will be used to look for abnormalities in these senses.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Insight Into the Ontogeny of GnRH Neurons From Patients Born Without a Nose.
Delaney A, Volochayev R, Meader B, Lee J, et al · · 2020 · cited 12× · PMID 32034419 · DOI 10.1210/clinem/dgaa065
Verify or expand the search:
- PubMed search for NCT01511588
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01511588 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institute of Environmental Health Sciences (NIEHS)
- Last refreshed: 14 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01511588.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing