drugset / Trial / NCT00000380
Growth Hormone Releasing Hormone (GHRH) Treatment for Age-Related Sleep Disturbances
Treatment
Summary
The purpose of this study is to examine the effects of giving growth hormone releasing hormone (GHRH) to treat sleep disorders in older men and in older women who are on estrogen replacement therapy (ERT). Many older men and women complain of sleep disturbances. GHRH has been used successfully to treat sleep disorders in young men and may help older men and women. 40 healthy older men and 40 healthy older women on ERT will receive either GHRH or an inactive placebo. An individual may be eligible for this study if he/she is a healthy older man or woman with sleep disturbances, and is on estrogen replacement therapy (women).
Timeline
- Start
- 1996-06
- Primary completion
- 2007-07
- Completion
- 2007-07
Publications
- Background Merriam GR, Schwartz RS, Vitiello MV. Growth hormone-releasing hormone and growth hormone secretagogues in normal aging. Endocrine. 2003 Oct;22(1):41-8. doi: 10.1385/ENDO:22:1:41.
- Background Merriam GR, Buchner DM, Prinz PN, Schwartz RS, Vitiello MV. Potential applications of GH secretagogs in the evaluation and treatment of the age-related decline in growth hormone secretion. Endocrine. 1997 Aug;7(1):49-52. doi: 10.1007/BF02778062.
- Results Vitiello MV, Moe KE, Merriam GR, Mazzoni G, Buchner DH, Schwartz RS. Growth hormone releasing hormone improves the cognition of healthy older adults. Neurobiol Aging. 2006 Feb;27(2):318-23. doi: 10.1016/j.neurobiolaging.2005.01.010. Epub 2005 Mar 23.
- Results Vitiello MV, Larsen LH, Moe KE. Age-related sleep change: Gender and estrogen effects on the subjective-objective sleep quality relationships of healthy, noncomplaining older men and women. J Psychosom Res. 2004 May;56(5):503-10. doi: 10.1016/S0022-3999(04)00023-6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SOMATORELIN | Protein / enzyme biologic | — | — |