drugset / Trial / NCT01116401
Impact of Hot Flashes on Sleep and Mood Disturbance
Phase 4
Completed
29 enrolled
Massachusetts General Hospital
National Institute of Mental Health (NIMH) · collab
NaSingle-groupOpen-labelBasic science
Summary
We plan to enroll premenopausal women in a trial investigating the impact of hot flashes developed in response to an injection of a gonadotropin-releasing hormone agonist (GnRHa), leuprolide (brand name: Lupron), on sleep disruption and mood. This study is designed to mimic the menopause transition. We will collect data on sleep disruption and mood changes to assess their relationship to the development of hot flashes.
Timeline
- Start
- 2009-11-03
- Primary completion
- 2011-12-29
- Completion
- 2012-01-04
Publications
- Joffe H, Crawford SL, Freeman MP, White DP, Bianchi MT, Kim S, Economou N, Camuso J, Hall JE, Cohen LS. Independent Contributions of Nocturnal Hot Flashes and Sleep Disturbance to Depression in Estrogen-Deprived Women. J Clin Endocrinol Metab. 2016 Oct;101(10):3847-3855. doi: 10.1210/jc.2016-2348. Epub 2016 Sep 28.
- Bianchi MT, Kim S, Galvan T, White DP, Joffe H. Nocturnal Hot Flashes: Relationship to Objective Awakenings and Sleep Stage Transitions. J Clin Sleep Med. 2016 Jul 15;12(7):1003-9. doi: 10.5664/jcsm.5936.
- Joffe H, Crawford S, Economou N, Kim S, Regan S, Hall JE, White D. A gonadotropin-releasing hormone agonist model demonstrates that nocturnal hot flashes interrupt objective sleep. Sleep. 2013 Dec 1;36(12):1977-85. doi: 10.5665/sleep.3244.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Leuprolide | Other / unclassified | 3.75 mg | Intramuscular |