NCT03034018

Brief Summary

The aim of this study is to determine the effect of suvorexant on insomnia symptoms in peri- and postmenopausal women who are experiencing sleep difficulties related to nighttime hot flashes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2017

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

May 25, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2020

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

October 29, 2021

Completed
Last Updated

March 14, 2022

Status Verified

March 1, 2022

Enrollment Period

2.9 years

First QC Date

January 25, 2017

Results QC Date

October 1, 2021

Last Update Submit

March 1, 2022

Conditions

Insomnia

Keywords

insomniahot flashesmenopausesuvorexantbelsomra

Outcome Measures

Primary Outcomes (1)

  • Within-person Change in ISI Score

    The Insomnia Severity Index (ISI) is a scale comprising seven questions scored 0-3. The total ISI score is the sum of all questions, with a total range from 0-21 with higher values indicating worse insomnia. Within-person change in ISI score from baseline to 4 weeks was calculated.

    baseline and 4 weeks

Study Arms (2)

suvorexant

EXPERIMENTAL

suvorexant 10-20 mg taken at bedtime for four weeks

Drug: suvorexant

placebo

PLACEBO COMPARATOR

placebo taken at bedtime for four weeks

Drug: placebo

Interventions

suvorexantDRUG

10-20 mg taken at bedtime for four weeks

Also known as: Belsomra
suvorexant
placeboDRUG

placebo taken at bedtime for four weeks

placebo

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Peri- or postmenopausal women
  • DSM-5 criteria for Insomnia disorder, with onset of symptoms attributed to hot flashes
  • Some awakenings co-occur with a hot flash
  • Score on the Insomnia Severity Index (ISI) measure ≥15
  • Hot flashes present, including at night

You may not qualify if:

  • Diagnosis of other primary sleep disorders
  • Shift workers
  • Current or expected use of hypnotic medications
  • Current major depressive episode
  • Lifetime history of bipolar disorder, psychosis, or other serious mental health problem
  • Current alcohol/substance use disorder
  • Obesity
  • Renal or hepatic disease
  • Pregnancy or breastfeeding
  • Recent malignancy
  • Recent surgery
  • Neurological disorder or cardiovascular disease raising safety concerns
  • Medical instability considered to interfere with study procedures
  • Concomitant medications with drug interaction or co-administration concerns
  • Contraindications or allergic responses to suvorexant
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Rahman SA, Nathan MD, Wiley A, Crawford S, Cohn AY, Harder JA, Grant LK, Erickson A, Srivastava A, McCormick K, Bertisch SM, Winkelman JW, Joffe H. A double-blind, randomized, placebo-controlled trial of suvorexant for the treatment of vasomotor symptom-associated insomnia disorder in midlife women. Sleep. 2022 Mar 14;45(3):zsac007. doi: 10.1093/sleep/zsac007.

    PMID: 35022783DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersHot Flashes

Interventions

suvorexant

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Hadine Joffe, MD MSc
Organization
Brigham and Women's Hospital
hjoffe@bwh.harvard.edu
617-732-4906

Study Officials

  • Hadine Joffe, MD MSc

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Director, Connors Center for Women's Health and Gender Biology

Study Record Dates

First Submitted

January 25, 2017

First Posted

January 27, 2017

Study Start

May 25, 2017

Primary Completion

April 3, 2020

Study Completion

April 3, 2020

Last Updated

March 14, 2022

Results First Posted

October 29, 2021

Record last verified: 2022-03

Locations

US(1)