Trial Outcomes & Findings for Impact of Hot Flashes on Sleep and Mood Disturbance (NCT NCT01116401)

Last Updated: 2018-01-23

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

29 participants

Primary outcome timeframe

baseline and 4 weeks

Results posted on

2018-01-23

Participant Flow

Participant milestones

Participant milestones
Measure	GnRH Agonist Injection One 3.75-mg intramuscular injection of leuprolide acetate
Overall Study STARTED	29
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impact of Hot Flashes on Sleep and Mood Disturbance

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GnRH Agonist Injection n=29 Participants One 3.75-mg intramuscular injection of leuprolide acetate
Age, Continuous	27.3 years STANDARD_DEVIATION 7.2 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 4 weeks

Outcome measures

Outcome measures
Measure	GnRH Agonist Injection n=29 Participants One 3.75-mg intramuscular injection of leuprolide acetate
Percent Change in Wake After Sleep Onset (WASO)	62 percent change Interval 18.0 to 106.0

SECONDARY outcome

Timeframe: baseline and 4 weeks

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.

Outcome measures

Outcome measures
Measure	GnRH Agonist Injection n=29 Participants One 3.75-mg intramuscular injection of leuprolide acetate
Change in Montgomery-Asperg Depression Rating Scale (MADRS)	3.1 units on a scale Standard Deviation 5.4

Adverse Events

GnRH Agonist Injection

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	GnRH Agonist Injection n=29 participants at risk One 3.75-mg intramuscular injection of leuprolide acetate
Blood and lymphatic system disorders Hot flashes	86.2% 25/29 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.
Nervous system disorders Headache/migraine	13.8% 4/29 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.
Metabolism and nutrition disorders Decreased appetite	10.3% 3/29 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.
Nervous system disorders Decreased Sleep/Insomnia	13.8% 4/29 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.
Psychiatric disorders Irritability/Mood changes	24.1% 7/29 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.
Reproductive system and breast disorders Spotting	41.4% 12/29 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.
Reproductive system and breast disorders Heavy menstrual bleeding	10.3% 3/29 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.
Gastrointestinal disorders Abdominal cramps	10.3% 3/29 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.

Additional Information

Hadine Joffe

Brigham & Women's Hospital

Phone: 617-732-4906

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place