Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5R01MH082922 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GnRH Agonist Injection | Experimental | We will be administering an injection of leuprolide acetate (a GnRH agonist) to all participants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| leuprolide | Drug | Leuprolide acetate is a widely used GnRH agonist. In this protocol, leuprolide will be administered at a dose routinely used for treatment of endometriosis and uterine fibroids in women (one 3.75-mg intramuscular injection). |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Wake After Sleep Onset (WASO) | Wake after sleep onset (WASO) is calculated by averaging the number of minutes spent awake after initiating sleep each night from the two ambulatory polysomnography studies conducted at baseline and the two ambulatory polysomnography studies conducted four weeks after the GnRHa injection. | baseline and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Montgomery-Asperg Depression Rating Scale (MADRS) | The Montgomery-Åsberg Depression Rating Scale is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms. It has a range of 0-60 with higher scores indicating greater symptom burden. Participants were assessed at baseline and four weeks after the GnRHa injection in order to calculate the change in MADRS score. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hadine Joffe, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27680875 | Derived | 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. | |
| 26951410 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | GnRH Agonist Injection | One 3.75-mg intramuscular injection of leuprolide acetate |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | GnRH Agonist Injection | One 3.75-mg intramuscular injection of leuprolide acetate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in Wake After Sleep Onset (WASO) | Wake after sleep onset (WASO) is calculated by averaging the number of minutes spent awake after initiating sleep each night from the two ambulatory polysomnography studies conducted at baseline and the two ambulatory polysomnography studies conducted four weeks after the GnRHa injection. | Posted | Number | 95% Confidence Interval | percent change | baseline and 4 weeks |
|
|
Not provided
To measure hot flashes, all subjects completed daily hot flash diaries through the fourth week after receiving the GnRHa and completing both ambulatory posttreatment PSGs. Nighttime hot flashes were measured objectively using an ambulatory skin conductance monitor concurrent with both post-treatment polysomnographic assessments.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GnRH Agonist Injection | One 3.75-mg intramuscular injection of leuprolide acetate |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hot flashes | Blood and lymphatic system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hadine Joffe | Brigham & Women's Hospital | 617-732-4906 | hjoffe@partners.org |
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| D019584 | Hot Flashes |
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D016729 | Leuprolide |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| baseline and 4 weeks |
| 24293774 | Derived | 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Change in Montgomery-Asperg Depression Rating Scale (MADRS) | The Montgomery-Åsberg Depression Rating Scale is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms. It has a range of 0-60 with higher scores indicating greater symptom burden. Participants were assessed at baseline and four weeks after the GnRHa injection in order to calculate the change in MADRS score. | Posted | Mean | Standard Deviation | units on a scale | baseline and 4 weeks |
|
|
|
|
| 0 |
| 29 |
| 28 |
| 29 |
| Headache/migraine | Nervous system disorders | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Decreased Sleep/Insomnia | Nervous system disorders | Non-systematic Assessment |
|
| Irritability/Mood changes | Psychiatric disorders | Non-systematic Assessment |
|
| Spotting | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Heavy menstrual bleeding | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Abdominal cramps | Gastrointestinal disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |