Trial Outcomes & Findings for Understanding Experimentally Induced Hot Flushes (NCT NCT00455689)
NCT ID: NCT00455689
Last Updated: 2018-09-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
baseline (before receiving intervention) and 4 weeks after receiving intervention
Results posted on
2018-09-18
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
6
|
|
Overall Study
COMPLETED
|
14
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Understanding Experimentally Induced Hot Flushes
Baseline characteristics by cohort
| Measure |
Developed Hot Flashes
n=14 Participants
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.
|
Did Not Develop Hot Flashes
n=6 Participants
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.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.8 years
STANDARD_DEVIATION 9.0 • n=93 Participants
|
25.5 years
STANDARD_DEVIATION 6.7 • n=4 Participants
|
30.6 years
STANDARD_DEVIATION 8.9 • n=27 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
8 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic or African-American
|
6 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: baseline (before receiving intervention) and 4 weeks after receiving interventionObjective 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.
Outcome measures
| Measure |
Developed Hot Flashes
n=14 Participants
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.
|
Did Not Develop Hot Flashes
n=6 Participants
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.
|
|---|---|---|
|
Percent Change in Objective Sleep Efficiency
|
-2.6 percent change
Interval -10.2 to -0.9
|
4.2 percent change
Interval 0.8 to 7.5
|
SECONDARY outcome
Timeframe: baseline (before receiving intervention) and 4 weeks after receiving interventionSleep 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.
Outcome measures
| Measure |
Developed Hot Flashes
n=14 Participants
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.
|
Did Not Develop Hot Flashes
n=6 Participants
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.
|
|---|---|---|
|
Change in Subjective Sleep Quality
|
2.5 units on a scale
Interval 1.0 to 4.0
|
1.0 units on a scale
Interval 1.0 to 2.0
|
Adverse Events
All Subjects
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Subjects
n=20 participants at risk
20 subjects who all received one leuprolide injection
|
|---|---|
|
Nervous system disorders
Headache
|
10.0%
2/20 • Number of events 2 • Subjects were monitored for 3 months following GnRHa administration
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.0%
1/20 • Number of events 1 • Subjects were monitored for 3 months following GnRHa administration
|
|
Gastrointestinal disorders
Bloating
|
5.0%
1/20 • Number of events 1 • Subjects were monitored for 3 months following GnRHa administration
|
|
Renal and urinary disorders
malodorous urine
|
5.0%
1/20 • Number of events 1 • Subjects were monitored for 3 months following GnRHa administration
|
|
General disorders
Fatigue
|
15.0%
3/20 • Number of events 3 • Subjects were monitored for 3 months following GnRHa administration
|
|
Psychiatric disorders
Irritability
|
5.0%
1/20 • Number of events 1 • Subjects were monitored for 3 months following GnRHa administration
|
|
General disorders
Increased libido
|
5.0%
1/20 • Number of events 1 • Subjects were monitored for 3 months following GnRHa administration
|
|
Vascular disorders
Edema
|
5.0%
1/20 • Number of events 1 • Subjects were monitored for 3 months following GnRHa administration
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
10.0%
2/20 • Number of events 2 • Subjects were monitored for 3 months following GnRHa administration
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place