NCT01281332

Brief Summary

Hypothesis: A mechanical device when applied to the back of the neck at the onset of a menopausal hot flash will attenuate the severity and duration of symptoms providing women with a reassuring non-hormonal intervention to improve quality of life in the menopausal transition. This pilot study will evaluate the effectiveness of this unit. The mechanism of action of the device will not be revealed in advance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2013

Shorter than P25 for phase_2

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 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 21, 2011

Completed
2.6 years until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

September 11, 2015

Status Verified

September 1, 2015

Enrollment Period

11 months

First QC Date

January 19, 2011

Last Update Submit

September 9, 2015

Conditions

Hot Flashes

Keywords

menopausehot flashquality of life

Outcome Measures

Primary Outcomes (1)

  • Hot flash score and duration

    Hot flash score is a product of frequency x intensity (Sloan 2001). Duration (minutes) will be recorded in diary.

    Change from baseline to end of study (week 4).

Secondary Outcomes (1)

  • Quality of Life (QOL) and Anxiety

    Change from baseline to end of study (week 4).

Study Arms (2)

Menopod device

ACTIVE COMPARATOR

Menopod®

Device: Menopod

Sham device

SHAM COMPARATOR

Inactive device.

Device: Inactive device

Interventions

MenopodDEVICE

The mechanism of action of the device will not be revealed in advance.

Menopod device
Inactive deviceDEVICE
Also known as: The mechanism of action of the active device is disabled.
Sham device

Eligibility Criteria

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

You may qualify if:

  • Age range: 40 to 65 years
  • Healthy postmenopausal woman
  • natural or surgical menopause
  • FSH \> 30 IU/L
  • Amenorrhea \> 6 months prior to study
  • Minimum of 7 moderate hot flashes per day documented in diary during evaluation phase

You may not qualify if:

  • Any therapy for hot flashes prior to or during study
  • Obesity: BMI \> 35
  • Alcohol abuse
  • Drug abuse
  • Unable to use device as per protocol
  • Unable to complete required documentation
  • Serious medical condition:
  • coronary heart disease
  • stroke
  • chronic renal or hepatic disease
  • diabetes
  • depression or other psychiatric illness
  • cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kingston General Hospital

Kingston, Ontario, K7L 2N6, Canada

Location

Related Publications (3)

  • Sloan JA, Loprinzi CL, Novotny PJ, Barton DL, Lavasseur BI, Windschitl H. Methodologic lessons learned from hot flash studies. J Clin Oncol. 2001 Dec 1;19(23):4280-90. doi: 10.1200/JCO.2001.19.23.4280.

    PMID: 11731510BACKGROUND

  • Carpenter JS. The Hot Flash Related Daily Interference Scale: a tool for assessing the impact of hot flashes on quality of life following breast cancer. J Pain Symptom Manage. 2001 Dec;22(6):979-89. doi: 10.1016/s0885-3924(01)00353-0.

    PMID: 11738160BACKGROUND

  • Zung WW. A rating instrument for anxiety disorders. Psychosomatics. 1971 Nov-Dec;12(6):371-9. doi: 10.1016/S0033-3182(71)71479-0. No abstract available.

    PMID: 5172928BACKGROUND

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Robert L. Reid, MD

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
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
Professor

Study Record Dates

First Submitted

January 19, 2011

First Posted

January 21, 2011

Study Start

September 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

September 11, 2015

Record last verified: 2015-09

Locations

CA(1)