Studies suggest that kappa agonists (KA) and peripherally restricted kappa agonists (PRKAs) may affect thermoregulation. This pilot study has the aim to establish proof of concept regarding efficacy of an oral kappa agonist (KA) for the treatment of menopausal hot flashes.
To establish proof of concept regarding efficacy of an oral kappa agonist (KA), Pentazocine/ Naloxone 50/0.5 mg, for the treatment of menopausal hot flashes. To gather data in support of a future proposal to study the safety and efficacy of a PRKA, a type of KA, for amelioration of menopausal hot flashes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
12
University of Washington
Seattle, Washington, United States
Hot Flashes
Objectively measured hot flash frequency by changes in skin conductance over 8 hours on 3 separate study visits 3-14 days apart.
Time frame: 1-4 weeks
Subjectively measured hot flashes
Self-reported diary documentation of time and occurence of hot flashes and intensity of hot flashes over 8 hours on 3 separate study visits 3-14 days apart.
Time frame: 1-4 weeks
Change in Serum Leutinizing Hormone
Serum collected at each visit baseline (before administration of treatment) and at 20-minute intervals over 8 hours on 3 separate study visits 3-14 days apart.
Time frame: 1-4 weeks
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