Back to resultsEffects of a Kappa Agonist on Hot Flashes in Menopausal Women
Primary Purpose
Treatment of Menopausal Hot Flashes
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Standard Dose Kappa Agonist
Half Dose Kappa Agonist
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Treatment of Menopausal Hot Flashes focused on measuring hot flashes, menopause, kappa agonist
Eligibility Criteria
Inclusion Criteria:
- Healthy women 45-60 years of age; 12 months amenorrhea
- Documentation of > 8 moderate to severe, daily hot flashes during one week of baseline monitoring using daily diaries
- Availability of a family member or friend to drive participant home following clinic visits
Exclusion Criteria:
- Use of hormonal prescription medication or supplements for vasomotor symptoms (VMS)
- Use of narcotics
- Use of SSRI (selective serotonin reuptake inhibitor)/SNRI (serotonin-norepinephrine reuptake inhibitors), gabapentin, MAOI (monoamine oxidase inhibitor), anti-epileptics, sedatives
- History of polycystic ovarian syndrome or hirsutism
- Current history of depression
- Any chronic or acute medical illnesses including renal, hepatic, pulmonary diseases, or seizures
- Substance abuse
- Severe corn allergy
- Known allergic reaction to pentazocine or naloxone
- 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
- Hysterectomy
- Use of anticholinergic medications
- Lactating or pregnant
Sites / Locations
- University of Washington
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
Standard Dose Kappa Agonist
Half Dose Kappa Agonist
Arm Description
Cornstarch, National Formulary
Pentazocine/Naloxone 50/0.5 mg
Pentazocine/Naloxone 25/0.25 mg
Outcomes
Primary Outcome Measures
Hot Flashes
Objectively measured hot flash frequency by changes in skin conductance over 8 hours on 3 separate study visits 3-14 days apart.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT02070718
First Posted
February 21, 2014
Last Updated
June 29, 2015
Sponsor
University of Washington
Collaborators
National Institute on Aging (NIA), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Complementary and Integrative Health (NCCIH), Office of Research on Women's Health (ORWH), National Center for Advancing Translational Sciences (NCATS)
1. Study Identification
Unique Protocol Identification Number
NCT02070718
Brief Title
Effects of a Kappa Agonist on Hot Flashes in Menopausal Women
Official Title
Effects of a Kappa Agonist on Hot Flashes in Menopausal Women
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute on Aging (NIA), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Complementary and Integrative Health (NCCIH), Office of Research on Women's Health (ORWH), National Center for Advancing Translational Sciences (NCATS)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment of Menopausal Hot Flashes
Keywords
hot flashes, menopause, kappa agonist
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Cornstarch, National Formulary
Arm Title
Standard Dose Kappa Agonist
Arm Type
Experimental
Arm Description
Pentazocine/Naloxone 50/0.5 mg
Arm Title
Half Dose Kappa Agonist
Arm Type
Experimental
Arm Description
Pentazocine/Naloxone 25/0.25 mg
Intervention Type
Drug
Intervention Name(s)
Standard Dose Kappa Agonist
Other Intervention Name(s)
Pentazocine/Naloxone 50/0.5 mg
Intervention Type
Drug
Intervention Name(s)
Half Dose Kappa Agonist
Other Intervention Name(s)
Pentazocine/Naloxone 25/0.25 mg
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Hot Flashes
Description
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
Secondary Outcome Measure Information:
Title
Subjectively measured hot flashes
Description
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
Title
Change in Serum Leutinizing Hormone
Description
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
Other Pre-specified Outcome Measures:
Title
Serum Follicle Stimulating Hormone
Description
Baseline (1st visit) single time point
Time Frame
Baseline only
Title
Serum Estradiol
Description
Baseline (1st visit) single time point only.
Time Frame
Baseline only
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy women 45-60 years of age; 12 months amenorrhea
Documentation of > 8 moderate to severe, daily hot flashes during one week of baseline monitoring using daily diaries
Availability of a family member or friend to drive participant home following clinic visits
Exclusion Criteria:
Use of hormonal prescription medication or supplements for vasomotor symptoms (VMS)
Use of narcotics
Use of SSRI (selective serotonin reuptake inhibitor)/SNRI (serotonin-norepinephrine reuptake inhibitors), gabapentin, MAOI (monoamine oxidase inhibitor), anti-epileptics, sedatives
History of polycystic ovarian syndrome or hirsutism
Current history of depression
Any chronic or acute medical illnesses including renal, hepatic, pulmonary diseases, or seizures
Substance abuse
Severe corn allergy
Known allergic reaction to pentazocine or naloxone
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
Hysterectomy
Use of anticholinergic medications
Lactating or pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan D Reed, MD, MPH
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25988798
Citation
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.
Results Reference
derived
Learn more about this trial
Effects of a Kappa Agonist on Hot Flashes in Menopausal Women
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