Normal Healthy Volunteers Clinical Trial
Official title:
Pilot Study of Estradiol-Receptor Blockade in Older Men and Women
Repletion of testosterone (Te) in older men drives GH secretion after its aromatization to estradiol (E2), which acts via the estrogen receptor (ER). Conversely, we postulate that estrogen deprivation in postmenopausal women attenuates growth hormone (GH) secretion and insulin-like growth factor-1 (IGF-I) production, thus favoring development of metabolic syndrome in men treated with toremifene, a new estrogen antagonist used adjunctively in prostatic cancer
Systemic concentrations of Te, E2, GH, IGF-I and insulin growth factor binding protein 3 (IGFBP-3) decline in healthy aging men and women. Relative sex-steroid deprivation accentuates GH and IGF-I depletion, since Te stimulates GH and IGF-I production in older men, hypogonadal males of all ages, and patients undergoing (genotypic female-to-male) gender reassignment. The estrogen-receptor antagonist, tamoxifen, blocks this effect of Te, suggesting involvement of E2 in GH's stimulation at least in young men. E2 alone stimulates GH secretion in young and older women. Because Te is converted to E2 by aromatization in the body, we postulate that E2 is the active moiety in both men and women. Moreover, we hypothesize that the decline of E2 in older men and women contributes to the fall in GH output. These basic concepts will be tested here. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05019950 -
Safety Tolerability and Pharmacokinetics of Oral NIM-1324 in Healthy Adult Male and Female Volunteers
|
Phase 1 | |
| Completed |
NCT01366339 -
Tolerance and Pharmacokinetics Study of MNTX Tablets
|
Phase 1 | |
| Completed |
NCT01862835 -
Impact of Estradiol Addback
|
Phase 1 | |
| Completed |
NCT01629446 -
Lofexidine Mass Balance in Volunteers
|
Phase 1 | |
| Completed |
NCT02026973 -
Impact of Endogenous E2 on SSI and GH Rebound
|
Phase 1 | |
| Completed |
NCT03860571 -
Safety, Tolerability, and Pharmacokinetics of Oral BT-11 in Healthy Adult Male and Female Volunteers
|
Phase 1 | |
| Recruiting |
NCT03234504 -
Development and Validation of a Novel Stereoacuity Test Using Head-mounted Display
|
||
| Completed |
NCT04188730 -
A Study Evaluating the Relative Bioavailability of Lofexidine Granules for Reconstitution Compared to LUCEMYRA (Lofexidine) Tablets and the Effect of Food on the Bioavailability of the Lofexidine Granules for Reconstitution
|
Phase 1 | |
| Withdrawn |
NCT03291158 -
Safety and PK Trial Evaluating the Plasma, Epithelial Lining Fluid, and Alveolar Macrophage Concentrations of Minocin IV
|
Phase 1 | |
| Completed |
NCT02802631 -
Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Minocin (Minocycline) for Injection in Healthy Adults
|
Phase 1 |