Hot Flashes
Conditions
Keywords
Lupron, Premenopausal, Hot flashes
Brief summary
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.
Interventions
DRUGLeuprolide acetate
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.
Sponsors
Endocrine Research Society
Massachusetts General Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Women 18-45 years old * Premenopausal * Willingness to use barrier methods of contraception during study and after completion of study until menses resume * Good general health
Exclusion criteria
* Pregnancy * Breastfeeding * Hot flushes * Hemoglobin at the screening visit less than 10 gm/dL * Abnormal liver function tests * Abnormal renal function tests * BMI \> 35 kg/m2 * Previously diagnosed osteoporosis or osteopenia * Psychiatric disorder involving mood, anxiety, psychotic disorder, current anorexia nervosa, or current alcohol or substance-use disorder * Previous severe depression * Evidence of suicidal or homicidal ideation * Sleep apnea, narcolepsy, or other diagnosed sleep disorder * Contraindication, hypersensitivity, or previous allergic reaction to GnRH agonists * Regular use of centrally active medications * Use of hormonal medications for at least 2 months * Use of ketoconazole, clomiphene citrate, or anabolic/androgenic steroids in the preceding 3 months * Renal insufficiency * Abnormal vaginal bleeding * History of thrombo-embolism or cardiovascular disease * History of congestive heart failure or other conditions requiring sodium restriction * History of spinal cord compression * Metastatic vertebral lesions * Memory disorders * Urinary tract obstruction * History of liver, kidney, pulmonary, or metabolic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Objective Sleep Efficiency | baseline (before receiving intervention) and 4 weeks after receiving intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Subjective Sleep Quality | baseline (before receiving intervention) and 4 weeks after receiving intervention | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| 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. | 6 |
| Total | 20 |
Baseline characteristics
| Characteristic | Developed Hot Flashes | Did Not Develop Hot Flashes | Total |
|---|---|---|---|
| Age, Continuous | 32.8 years STANDARD_DEVIATION 9 | 25.5 years STANDARD_DEVIATION 6.7 | 30.6 years STANDARD_DEVIATION 8.9 |
| Race/Ethnicity, Customized Hispanic or African-American | 6 Participants | 3 Participants | 9 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 8 Participants | 3 Participants | 11 Participants |
| Sex: Female, Male Female | 14 Participants | 6 Participants | 20 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 13 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
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.
Time frame: baseline (before receiving intervention) and 4 weeks after receiving intervention
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Developed Hot Flashes | Percent Change in Objective Sleep Efficiency | -2.6 percent change |
| Did Not Develop Hot Flashes | Percent Change in Objective Sleep Efficiency | 4.2 percent change |
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.
Time frame: baseline (before receiving intervention) and 4 weeks after receiving intervention
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Developed Hot Flashes | Change in Subjective Sleep Quality | 2.5 units on a scale |
| Did Not Develop Hot Flashes | Change in Subjective Sleep Quality | 1.0 units on a scale |