Status
Recruiting
Phase
N/A
Study type
Observational
Enrollment
60
Sex
Women only
Ages
Ages 40 Years to 70 Years
Primary completion
2027-05-26
Last update
2026-05-07

What this trial studies

The overall objective of this study is to examine the physiological responses that occur during a hot flush in postmenopausal women. The following specific aims will be executed to reach the overall objective of this study. Aim 1: To determine if hot flushes can be reliably induced with a temperature-controlled, water- circulating (TCWC) heating pad. Based on previous research, the investigators hypothesize that hot flushes will be inducible with the TCWC in symptomatic women, but not in asymptomatic women.

Conditions in scope

  • Hot Flashes
  • Menopause

Interventions

  • Hot Flush Induction (Other) — A temperature-controlled, water-circulating heating pad at a constant temperature of 107˚F will be placed on the participant's torso, a microwaved heating neck pad will be placed on the participant's neck, and two warm balloons will be placed in the participant's…

Who can join

Women only · Ages 40 Years to 70 Years · Accepts healthy volunteers.

Inclusion criteria

  • Postmenopausal (may have or may not have hot flushes)
  • Have not started hormone therapy and/or will discontinue hormone therapy for the duration of the study

Exclusion criteria

  • Reported nicotine/tobacco use within the last six months
  • Diabetic or asthmatic
  • Diagnosed significant carotid stenosis
  • History of significant autonomic dysfunction, heart disease, respiratory disease, or severe neurologic condition such as stroke or traumatic brain injury
  • Existing metabolic or endocrine abnormalities
  • Use of heart/blood pressure medications that are determined to interfere with study outcomes
  • Unwilling to discontinue use of OC (or other hormonal contraceptives, including intrauterine devices or contraceptive implants) and/or MHT
  • Pregnant or breastfeeding

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

CityState / RegionFacilitySite status
Minneapolis Minnesota University of Minnesota Recruiting

Status & timeline

  • Overall status: Recruiting
  • Study type: Observational
  • Phase: N/A
  • Start date: 2022-03-01
  • Primary completion: 2027-05-26
  • Last update posted: 2026-05-07
  • First posted: 2022-02-22

Lead sponsor: University of Minnesota (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

  • Systolic Blood pressure (mmHg) (3 hours)
    Blood pressure will be measured using a non-invasive blood pressure cuff and measured in units of mmHG and assessed at Visit 2.
  • Diastolic Blood pressure (3 hours)
    Blood pressure will be measured using a non-invasive blood pressure cuff and measured in units of mmHG and assessed at Visit 2.
  • Mean arterial Blood pressure (3 hours)
    Blood pressure will be measured using a non-invasive blood pressure cuff and measured in units of mmHG and assessed at Visit 2.
  • Skin conductance (3 hours)
    Skin conductance is measured using galvanic skin response and is measured in umho. Skin conductance will be assessed at Visit 2.
  • Skin temperature (3 hours)
    Skin temperature will be measured by a skin thermometer and reported in °C or °F as an objective measure of hot flushes. Skin temperature will be assessed at Visit 2.

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.

Important. Information from ClinicalTrials.gov as of May 8, 2026. Trial details (status, sites, contacts, eligibility, outcomes) change frequently — always check the official record at https://clinicaltrials.gov/study/NCT05251324 before contacting a site.

ClearedRx is not affiliated with this trial or its sponsor. We index public-domain ClinicalTrials.gov records to help patients find evidence-based context for menopause care decisions. ClearedRx itself is a telehealth menopause/HRT brand — we do not enroll patients in trials.