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| Name | Class |
|---|---|
| Endocrine Research Society | OTHER |
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The purpose of the study is to examine the impact of hot flushes on sleep, mood, and well-being. The investigators will cause hot flushes by giving study participants the hormone medication, leuprolide (Lupron), which is a manufactured (artificial) hormone that makes the body think that it has reached menopause temporarily. Most women begin to have hot flushes within 4 weeks after taking leuprolide and resume menses 3 months later. The investigators will administer questionnaires to evaluate changes in sleep and mood over the course of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Developed hot flashes | Experimental | Subjects who developed hot flashes after receiving leuprolide acetate (3.75 mg intramuscular injection) |
|
| Did not develop hot flashes | Experimental | Subjects who did not develop hot flashes after receiving leuprolide acetate (3.75 mg intramuscular injection) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leuprolide acetate | Drug | Leuprolide acetate (Lupron Depot®) 3.75-mg intramuscular injection Leuprolide is a widely used gonadotropin-releasing hormone agonist (GnRHa) that is indicated for treatment of endometriosis, uterine fibroids, precocious puberty, and prostate cancer, and is used off-label for in-vitro fertilization and premenstrual syndrome. In this protocol, leuprolide will be administered once during the mid-luteal phase of the menstrual cycle at a dose routinely used for treatment of endometriosis and uterine fibroids in women. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Objective Sleep Efficiency | Objective sleep efficiency was measured using actigraphy. Sleep efficiency (percent of time spent asleep between bedtime and wake time) was calculated and averaged over 2 consecutive nights both before and 4 weeks after receiving the intervention. | baseline (before receiving intervention) and 4 weeks after receiving intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Subjective Sleep Quality | Sleep quality was measured using the Pittsburgh Sleep Quality Index (PSQI; range 0-21, higher score indicates poorer quality sleep), which was administered both before and four weeks after receiving the intervention. | baseline (before receiving intervention) and 4 weeks after receiving intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hadine Joffe, M.D., M.Sc. | 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 |
|---|---|---|---|
| 22723326 | Derived | Joffe H, Deckersbach T, Lin NU, Makris N, Skaar TC, Rauch SL, Dougherty DD, Hall JE. Metabolic activity in the insular cortex and hypothalamus predicts hot flashes: an FDG-PET study. J Clin Endocrinol Metab. 2012 Sep;97(9):3207-15. doi: 10.1210/jc.2012-1413. Epub 2012 Jun 20. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Developed Hot Flashes | Subjects who developed hot flashes after receiving leuprolide acetate (3.75 mg intramuscular injection) Leuprolide acetate: Leuprolide acetate (Lupron Depot®) 3.75-mg intramuscular injection Leuprolide is a widely used GnRH agonist that is indicated for treatment of endometriosis, uterine fibroids, precocious puberty, and prostate cancer, and is used off-label for in-vitro fertilization and premenstrual syndrome. In this protocol, leuprolide will be administered once during the mid-luteal phase of the menstrual cycle at a dose routinely used for treatment of endometriosis and uterine fibroids in women. |
| FG001 | Did Not Develop Hot Flashes | Subjects who did not develop hot flashes after receiving leuprolide acetate (3.75 mg intramuscular injection) Leuprolide acetate: Leuprolide acetate (Lupron Depot®) 3.75-mg intramuscular injection Leuprolide is a widely used GnRH agonist that is indicated for treatment of endometriosis, uterine fibroids, precocious puberty, and prostate cancer, and is used off-label for in-vitro fertilization and premenstrual syndrome. In this protocol, leuprolide will be administered once during the mid-luteal phase of the menstrual cycle at a dose routinely used for treatment of endometriosis and uterine fibroids in women. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Developed Hot Flashes | Subjects who developed hot flashes after receiving leuprolide acetate (3.75 mg intramuscular injection) Leuprolide acetate: Leuprolide acetate (Lupron Depot®) 3.75-mg intramuscular injection Leuprolide is a widely used GnRH agonist that is indicated for treatment of endometriosis, uterine fibroids, precocious puberty, and prostate cancer, and is used off-label for in-vitro fertilization and premenstrual syndrome. In this protocol, leuprolide will be administered once during the mid-luteal phase of the menstrual cycle at a dose routinely used for treatment of endometriosis and uterine fibroids in women. |
| 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 Objective Sleep Efficiency | Objective sleep efficiency was measured using actigraphy. Sleep efficiency (percent of time spent asleep between bedtime and wake time) was calculated and averaged over 2 consecutive nights both before and 4 weeks after receiving the intervention. | Posted | Median | Inter-Quartile Range | percent change | baseline (before receiving intervention) and 4 weeks after receiving intervention |
|
Subjects were monitored for 3 months following GnRHa administration
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Subjects | 20 subjects who all received one leuprolide injection | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hadine Joffe, MD MSc | Brigham & Women's Hospital | 617-732-4906 | hjoffe@bwh.harvard.edu |
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| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016729 | Leuprolide |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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|
|
| BG001 | Did Not Develop Hot Flashes | Subjects who did not develop hot flashes after receiving leuprolide acetate (3.75 mg intramuscular injection) Leuprolide acetate: Leuprolide acetate (Lupron Depot®) 3.75-mg intramuscular injection Leuprolide is a widely used GnRH agonist that is indicated for treatment of endometriosis, uterine fibroids, precocious puberty, and prostate cancer, and is used off-label for in-vitro fertilization and premenstrual syndrome. In this protocol, leuprolide will be administered once during the mid-luteal phase of the menstrual cycle at a dose routinely used for treatment of endometriosis and uterine fibroids in women. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Did Not Develop Hot Flashes | Subjects who did not develop hot flashes after receiving leuprolide acetate (3.75 mg intramuscular injection) Leuprolide acetate: Leuprolide acetate (Lupron Depot®) 3.75-mg intramuscular injection Leuprolide is a widely used GnRH agonist that is indicated for treatment of endometriosis, uterine fibroids, precocious puberty, and prostate cancer, and is used off-label for in-vitro fertilization and premenstrual syndrome. In this protocol, leuprolide will be administered once during the mid-luteal phase of the menstrual cycle at a dose routinely used for treatment of endometriosis and uterine fibroids in women. |
|
|
| Secondary | Change in Subjective Sleep Quality | Sleep quality was measured using the Pittsburgh Sleep Quality Index (PSQI; range 0-21, higher score indicates poorer quality sleep), which was administered both before and four weeks after receiving the intervention. | Posted | Median | Inter-Quartile Range | units on a scale | baseline (before receiving intervention) and 4 weeks after receiving intervention |
|
|
|
| 20 |
| 0 |
| 20 |
| 13 |
| 20 |
| Acne | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Bloating | Gastrointestinal disorders | Non-systematic Assessment |
|
| malodorous urine | Renal and urinary disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Irritability | Psychiatric disorders | Non-systematic Assessment |
|
| Increased libido | General disorders | Non-systematic Assessment |
|
| Edema | Vascular disorders | Non-systematic Assessment |
|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| 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 |