A Phase 1 interventional study of Standard Dose Kappa Agonist and Half Dose Kappa Agonist in Treatment of Menopausal Hot Flashes, sponsored by University of Washington. Completed at 1 site in United States. Open to female participants aged 45 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-07-01.
Sponsored by University of Washington · Phase 1, Interventional, and Treatment
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.
284 studies on the registry are indexed under Hot Flashes; 49 are open to participants now.
This study's enrollment of 12 is below the median of 90 across 254 interventional studies indexed under Hot Flashes.
Browse Hot Flashes studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cornstarch, National Formulary
Other: Placebo
Pentazocine/Naloxone 50/0.5 mg
Drug: Standard Dose Kappa Agonist
Pentazocine/Naloxone 25/0.25 mg
Drug: Half Dose Kappa Agonist
Also known as: Pentazocine/Naloxone 50/0.5 mg
Also known as: Pentazocine/Naloxone 25/0.25 mg
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
Serum Follicle Stimulating Hormone
Baseline (1st visit) single time point
Time frame: Baseline only
Serum Estradiol
Baseline (1st visit) single time point only.
Time frame: Baseline only
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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University of Washington