Trial · Interventional

CompletedPhase 4Results postedRegistry data

Impact of Hot Flashes on Sleep and Mood Disturbance

NCTNCT01116401Other id2009-P-001557Other id5R01MH082922

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 4
Enrollment: 29 participants (actual)
Sponsor: Massachusetts General Hospital · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: 3 Nov 2009
Primary completion: 29 Dec 2011
Completion: 4 Jan 2012
First posted: 5 May 2010 (estimated)
Last update posted: 23 Jan 2018
Conditions: Menopause · Depression · Hot Flashes

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20092010201120122013

Ph 4
Impact of Hot Flashes on Sleep and Mood Disturbance
NCT01116401
3 Nov 2009 to 4 Jan 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

We plan to enroll premenopausal women in a trial investigating the impact of hot flashes developed in response to an injection of a gonadotropin-releasing hormone agonist (GnRHa), leuprolide (brand name: Lupron), on sleep disruption and mood. This study is designed to mimic the menopause transition. We will collect data on sleep disruption and mood changes to assess their relationship to the development of hot flashes.

Interventions

leuprolideDrug

Arms1

Experimental
GnRH Agonist Injection
We will be administering an injection of leuprolide acetate (a GnRH agonist) to all participants.

Primary outcomes1

Outcomes the sponsor listed as primary.

Percent Change in Wake After Sleep Onset (WASO)
Time frame · baseline and 4 weeks
Registry description
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.

Secondary outcomes(1)

Change in Montgomery-Asperg Depression Rating Scale (MADRS)
Time frame · baseline and 4 weeks
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· baseline and 4 weeks

Percent Change in Wake After Sleep Onset (WASO)

Group	Value (percent change)
GnRH Agonist Injection	62

Secondary and other outcome results(1)

Secondary outcomeMean· baseline and 4 weeks

Change in Montgomery-Asperg Depression Rating Scale (MADRS)

Group	Value (units on a scale)	Spread
GnRH Agonist Injection	3.1	5.4

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
GnRH Agonist InjectionOne 3.75-mg intramuscular injection of leuprolide acetate	–	0 / 29	28 / 29

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

More studies

2 studies on this page

PubMed tag: none · 2016

Corrected

Nocturnal Hot Flashes: Relationship to Objective Awakenings and Sleep Stage Transitions.

Bianchi et al. 2016Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicinecited by 31

PMID 26951410PMC4918982DOI 10.5664/jcsm.5936PUB-26951410

Rights unknown

Source link Read the notice

PubMed tag: none · 2016

Independent Contributions of Nocturnal Hot Flashes and Sleep Disturbance to Depression in Estrogen-Deprived Women.

Joffe et al. 2016The Journal of clinical endocrinology and metabolismcited by 57

PMID 27680875PMC5052351DOI 10.1210/jc.2016-2348PUB-27680875

Rights unknown

Source link

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedJoffe H, Crawford S, Economou N, Kim S, Regan S, Hall JE, White D. A gonadotropin-releasing hormone agonist model demonstrates that nocturnal hot flashes interrupt objective sleep. Sleep. 2013 Dec 1;36(12):1977-85. doi: 10.5665/sleep.3244. PMID 24293774

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 45 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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 or currently breastfeeding * Hot flushes * Mid-luteal phase progesterone \<3ng/mL * Clinically significant abnormalities in screening blood tests * BMI \> 35 kg/m2 * Previously diagnosed osteoporosis or osteopenia * Clinically significant depressive symptoms * Psychiatric illness * Sleep apnea or periodic limb movement of sleep (PLMS) * Contraindication, hypersensitivity, or previous allergic reaction to GnRH agonists * Current or recent use of centrally active medications * Current or recent use of systemic hormone medications * Night shift workers * Current use of over-the-counter (OTC) medications that may affect hot flashes, sleep, or mood * Abnormal vaginal bleeding * History of any medical diseases that may put subject at risk when treated with study medication.

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