Effects of a Kappa Agonist on Hot Flashes in Menopausal Women
NCT ID: NCT02070718
Last Updated: 2015-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2013-01-31
2013-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Cornstarch, National Formulary
Placebo
Standard Dose Kappa Agonist
Pentazocine/Naloxone 50/0.5 mg
Standard Dose Kappa Agonist
Half Dose Kappa Agonist
Pentazocine/Naloxone 25/0.25 mg
Half Dose Kappa Agonist
Interventions
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Standard Dose Kappa Agonist
Half Dose Kappa Agonist
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
45 Years
60 Years
FEMALE
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Center for Complementary and Integrative Health (NCCIH)
NIH
Office of Research on Women's Health (ORWH)
NIH
National Center for Advancing Translational Sciences (NCATS)
NIH
University of Washington
OTHER
Responsible Party
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Susan Reed
Professor, Obstetrics & Gynecology
Principal Investigators
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Susan D Reed, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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University of Washington
Seattle, Washington, United States
Countries
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References
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Oakley AE, Steiner RA, Chavkin C, Clifton DK, Ferrara LK, Reed SD. kappa Agonists as a novel therapy for menopausal hot flashes. Menopause. 2015 Dec;22(12):1328-34. doi: 10.1097/GME.0000000000000476.
Other Identifiers
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GYN-01-2012
Identifier Type: OTHER
Identifier Source: secondary_id
43952-B
Identifier Type: -
Identifier Source: org_study_id
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