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Effects of a Kappa Agonist on Hot Flashes in Menopausal Women

Information source: University of Washington
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Treatment of Menopausal Hot Flashes

Intervention: Standard Dose Kappa Agonist (Drug); Half Dose Kappa Agonist (Drug); Placebo (Other)

Phase: Phase 1

Status: Completed

Sponsored by: University of Washington

Official(s) and/or principal investigator(s):
Susan D Reed, MD, MPH, Principal Investigator, Affiliation: University of Washington

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Hot Flashes

Secondary outcome:

Subjectively measured hot flashes

Change in Serum Leutinizing Hormone

Detailed description: 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.

Eligibility

Minimum age: 45 Years. Maximum age: 60 Years. Gender(s): Female.

Criteria:

Inclusion Criteria: 1. Healthy women 45-60 years of age; 12 months amenorrhea 2. Documentation of > 8 moderate to severe, daily hot flashes during one week of baseline monitoring using daily diaries 3. Availability of a family member or friend to drive participant home following clinic visits Exclusion Criteria: 1. Use of hormonal prescription medication or supplements for vasomotor symptoms (VMS) 2. Use of narcotics 3. Use of SSRI (selective serotonin reuptake inhibitor)/SNRI (serotonin-norepinephrine reuptake inhibitors), gabapentin, MAOI (monoamine oxidase inhibitor), anti-epileptics, sedatives 4. History of polycystic ovarian syndrome or hirsutism 5. Current history of depression 6. Any chronic or acute medical illnesses including renal, hepatic, pulmonary diseases, or seizures 7. Substance abuse 8. Severe corn allergy 9. Known allergic reaction to pentazocine or naloxone 10. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data 11. Hysterectomy 12. Use of anticholinergic medications 13. Lactating or pregnant

Locations and Contacts

University of Washington, Seattle, Washington 98195, United States
Additional Information

Starting date: January 2013
Last updated: June 29, 2015

Page last updated: August 23, 2015

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