Treatment of Menopausal Hot Flashes
Conditions
Keywords
hot flashes, menopause, kappa agonist
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.
Interventions
DRUGStandard Dose Kappa Agonist
DRUGHalf Dose Kappa Agonist
OTHERPlacebo
Sponsors
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)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hot Flashes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjectively measured hot flashes | 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 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Serum Follicle Stimulating Hormone | Baseline only | Baseline (1st visit) single time point |
| Serum Estradiol | Baseline only | Baseline (1st visit) single time point only. |
Countries
United States
Outcome results
None listed