Trial Outcomes & Findings for Menopausal Sleep Fragmentation and Body Fat Gain (NCT NCT03047330)
NCT ID: NCT03047330
Last Updated: 2024-10-08
Results Overview
12-hr overnight fasted AM (morning) blood samples were assayed for leptin levels on study days 2-6 under both estrogenized and estradiol-withdrawal conditions \[total: 10 samples\]. For each individual, leptin values were normalized relative to the mean baseline leptin value. Baseline was defined as the unfragmented estrogenized condition (avg. of study days 2-3 in the estrogenized condition).
COMPLETED
PHASE4
41 participants
pre/post sleep fragmentation (3 days); pre/post estradiol withdrawal (~5 weeks)
2024-10-08
Participant Flow
Participant milestones
| Measure |
Study Arm
All participants who initiated Sleep Block 1
|
|---|---|
|
Sleep Block 1
STARTED
|
41
|
|
Sleep Block 1
COMPLETED
|
38
|
|
Sleep Block 1
NOT COMPLETED
|
3
|
|
Sleep Block 2
STARTED
|
27
|
|
Sleep Block 2
COMPLETED
|
27
|
|
Sleep Block 2
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Study Arm
All participants who initiated Sleep Block 1
|
|---|---|
|
Sleep Block 1
Withdrawal by Subject
|
3
|
Baseline Characteristics
Menopausal Sleep Fragmentation and Body Fat Gain
Baseline characteristics by cohort
| Measure |
Baseline Study Arm
n=38 Participants
All participants who completed Sleep Block 1
|
|---|---|
|
Age, Continuous
|
29.4 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: pre/post sleep fragmentation (3 days); pre/post estradiol withdrawal (~5 weeks)Population: To compare between study conditions, leptin levels \[12-hr overnight fasted AM samples\] were averaged across 2 samples \[on study days 2-3\] before 2 nights of sleep fragmentation and across 3 samples \[on study days 4-6\] after 3 nights of sleep fragmentation. Leptin levels were averaged across 5 samples \[on study days 2-6\] \~1 week before leuprolide administration (pre-estradiol withdrawal) and across 5 samples \[on study days 2-6\] \~4 weeks after leuprolide administration (post-estradiol withdrawal)
12-hr overnight fasted AM (morning) blood samples were assayed for leptin levels on study days 2-6 under both estrogenized and estradiol-withdrawal conditions \[total: 10 samples\]. For each individual, leptin values were normalized relative to the mean baseline leptin value. Baseline was defined as the unfragmented estrogenized condition (avg. of study days 2-3 in the estrogenized condition).
Outcome measures
| Measure |
Sleep Fragmentation - Active
n=38 Participants
Participants after 3 nights of experimentally-fragmented sleep
Fragmented sleep: Fragmented sleep will be experimentally induced.
|
Sleep Fragmentation - Control
n=38 Participants
Participants after 2 nights of unfragmented sleep
|
Estradiol Withdrawal - Active
n=27 Participants
Participants after experimentally-induced hypo-estradiol
Estradiol withdrawal: one injection of open-label intramuscular dose of leuprolide (3.75-mg depot), a gonadotropin-releasing hormone agonist that rapidly suppresses estradiol and temporarily achieves ovarian suppression.
|
Estradiol Withdrawal - Control
n=38 Participants
Participants during high-estradiol phase of menstrual cycle
|
|---|---|---|---|---|
|
Normalized Serum Leptin Levels
|
96.7 percentage of mean baseline leptin
Standard Error 2.5
|
94.0 percentage of mean baseline leptin
Standard Error 1.5
|
90.0 percentage of mean baseline leptin
Standard Error 3.0
|
101.0 percentage of mean baseline leptin
Standard Error 1.1
|
SECONDARY outcome
Timeframe: pre/post sleep fragmentation (3 days); pre/post estradiol withdrawal (~5 weeks)Population: To compare between study conditions, satiety scores \[12-hr overnight fasted AM satiety scores\] were averaged across 2 scores \[on study days 2-3\] before sleep fragmentation and across 3 scores \[on study days 4-6\] after 3 nights of sleep fragmentation. Satiety scores were averaged across 5 scores \[on study days 2-6\] \~1 week before leuprolide administration (pre-estradiol withdrawal) and across 5 scores \[on study days 2-6\] \~4 weeks after leuprolide administration (post-estradiol withdrawal).
12-hr overnight fasted AM satiety scores were collected on study days 2-6 under both estrogenized and estradiol-withdrawal conditions \[total: 10 scores\]. For each individual, satiety scores were normalized relative to the mean baseline satiety score. Baseline was defined as the unfragmented estrogenized condition (avg. of study days 2-3 in the estrogenized condition).
Outcome measures
| Measure |
Sleep Fragmentation - Active
n=38 Participants
Participants after 3 nights of experimentally-fragmented sleep
Fragmented sleep: Fragmented sleep will be experimentally induced.
|
Sleep Fragmentation - Control
n=38 Participants
Participants after 2 nights of unfragmented sleep
|
Estradiol Withdrawal - Active
n=27 Participants
Participants after experimentally-induced hypo-estradiol
Estradiol withdrawal: one injection of open-label intramuscular dose of leuprolide (3.75-mg depot), a gonadotropin-releasing hormone agonist that rapidly suppresses estradiol and temporarily achieves ovarian suppression.
|
Estradiol Withdrawal - Control
n=38 Participants
Participants during high-estradiol phase of menstrual cycle
|
|---|---|---|---|---|
|
Normalized Satiety Scores
|
99.2 percentage of mean baseline satiety
Standard Error 11.9
|
113.1 percentage of mean baseline satiety
Standard Error 11.0
|
102.6 percentage of mean baseline satiety
Standard Error 15.6
|
109.3 percentage of mean baseline satiety
Standard Error 7.8
|
Adverse Events
All Participants
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Participants
n=41 participants at risk
All participants who initiated study procedures
|
|---|---|
|
General disorders
Fatigue
|
7.3%
3/41 • Number of events 3 • 4 months
Since participants received interventions simultaneously, it was not possible to attribute adverse events to any one intervention. Therefore, adverse events are presented for the larger group of all participants who initiated study procedures.
|
|
Gastrointestinal disorders
Gastrointestional disturbance
|
17.1%
7/41 • Number of events 7 • 4 months
Since participants received interventions simultaneously, it was not possible to attribute adverse events to any one intervention. Therefore, adverse events are presented for the larger group of all participants who initiated study procedures.
|
|
Nervous system disorders
Headache
|
36.6%
15/41 • Number of events 15 • 4 months
Since participants received interventions simultaneously, it was not possible to attribute adverse events to any one intervention. Therefore, adverse events are presented for the larger group of all participants who initiated study procedures.
|
|
Gastrointestinal disorders
Nausea/vomiting
|
9.8%
4/41 • Number of events 4 • 4 months
Since participants received interventions simultaneously, it was not possible to attribute adverse events to any one intervention. Therefore, adverse events are presented for the larger group of all participants who initiated study procedures.
|
|
Skin and subcutaneous tissue disorders
Skin discomfort/irritation
|
43.9%
18/41 • Number of events 18 • 4 months
Since participants received interventions simultaneously, it was not possible to attribute adverse events to any one intervention. Therefore, adverse events are presented for the larger group of all participants who initiated study procedures.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory infection
|
7.3%
3/41 • Number of events 3 • 4 months
Since participants received interventions simultaneously, it was not possible to attribute adverse events to any one intervention. Therefore, adverse events are presented for the larger group of all participants who initiated study procedures.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
12.2%
5/41 • Number of events 5 • 4 months
Since participants received interventions simultaneously, it was not possible to attribute adverse events to any one intervention. Therefore, adverse events are presented for the larger group of all participants who initiated study procedures.
|
|
Reproductive system and breast disorders
Amenorrhea
|
7.3%
3/41 • Number of events 3 • 4 months
Since participants received interventions simultaneously, it was not possible to attribute adverse events to any one intervention. Therefore, adverse events are presented for the larger group of all participants who initiated study procedures.
|
|
Reproductive system and breast disorders
Menstrual
|
9.8%
4/41 • Number of events 4 • 4 months
Since participants received interventions simultaneously, it was not possible to attribute adverse events to any one intervention. Therefore, adverse events are presented for the larger group of all participants who initiated study procedures.
|
|
Reproductive system and breast disorders
Vasomotor symptoms
|
61.0%
25/41 • Number of events 25 • 4 months
Since participants received interventions simultaneously, it was not possible to attribute adverse events to any one intervention. Therefore, adverse events are presented for the larger group of all participants who initiated study procedures.
|
|
Injury, poisoning and procedural complications
IV discomfort/irritation
|
31.7%
13/41 • Number of events 13 • 4 months
Since participants received interventions simultaneously, it was not possible to attribute adverse events to any one intervention. Therefore, adverse events are presented for the larger group of all participants who initiated study procedures.
|
|
Nervous system disorders
Dizziness
|
9.8%
4/41 • Number of events 4 • 4 months
Since participants received interventions simultaneously, it was not possible to attribute adverse events to any one intervention. Therefore, adverse events are presented for the larger group of all participants who initiated study procedures.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place