Clinical Trial: Effects of a Kappa Agonist on Hot Flashes in Menopausal Women

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effects of a Kappa Agonist on Hot Flashes in Menopausal Women

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: University of Washington

Current Primary Outcome: Hot Flashes [ Time Frame: 1-4 weeks ]

Objectively measured hot flash frequency by changes in skin conductance over 8 hours on 3 separate study visits 3-14 days apart.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Subjectively measured hot flashes [ Time Frame: 1-4 weeks ]
    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.
  • Change in Serum Leutinizing Hormone [ Time Frame: 1-4 weeks ]
    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.


Original Secondary Outcome: Same as current

Information By: University of Washington

Dates:
Date Received: February 21, 2014
Date Started: January 2013
Date Completion:
Last Updated: June 29, 2015
Last Verified: June 2015