Status:
COMPLETED
Non-concealed Placebo Treatment for Menopausal Hot Flushes
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Conditions:
Hot Flashes
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
It has been long viewed that placebos cannot be administered in accordance with ethical values because deception is instrumental to the placebo effect. This notion has been shaken up by studies on ope...
Detailed Description
Beneficial effects of double-blind placebos were found to be high in hot flush trials. Recent studies demonstrating the efficacy of placebos without concealment provide a possible way to administer pl...
Eligibility Criteria
Inclusion
- at least 5 moderate or severe hot flushes per day, including night time
- all hot flushes have at least moderate ratings of bother (sum score ≥ 16 on the bother subscale of the Hot Flush Rating Scale (HFRS) \[41\]
- fluency in German language
- participants are in menopausal transition (irregularities ≥ 60 days in the past year), or postmenopausal (cessation of menstruation ≥ 1 year) \[42\].
Exclusion
- use of hormonal therapy to treat hot flushes within the last 6 weeks before enrolment
- use of herbal remedies to treat hot flushes within the last 6 weeks before enrolment
- intake of selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRI) within the last 6 weeks before enrolment
- previous oophorectomy
- severe physical or cognitive impairments which would constitute a barrier to give informed consent
- severe depression and anxiety (≥ 9 sum score or ≥ 5 depression or anxiety subscore on the Patient Health Questionnaire-4)
- medical conditions which might interact with menopausal hot flushes such as untreated hyperthyroidism, alcohol abuse (excluded when ≥4 on AUDIT-C) and cancer
Key Trial Info
Start Date :
February 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03838523
Start Date
February 12 2019
End Date
March 5 2020
Last Update
February 3 2021
Active Locations (1)
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1
University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 20251