Treatment of Menopausal Hot Flashes Clinical Trial
Official title:
Effects of a Kappa Agonist on Hot Flashes in Menopausal Women
| Verified date | June 2015 |
| Source | University of Washington |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 12 |
| Est. completion date | July 2013 |
| Est. primary completion date | July 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 45 Years to 60 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Washington | Seattle | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| University of Washington | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Advancing Translational Science (NCATS), National Center for Complementary and Integrative Health (NCCIH), National Institute on Aging (NIA), Office of Research and Women's Health (ORWH) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Serum Follicle Stimulating Hormone | Baseline (1st visit) single time point | Baseline only | No |
| Other | Serum Estradiol | Baseline (1st visit) single time point only. | Baseline only | No |
| Primary | Hot Flashes | Objectively measured hot flash frequency by changes in skin conductance over 8 hours on 3 separate study visits 3-14 days apart. | 1-4 weeks | No |
| Secondary | 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. | 1-4 weeks | No |
| Secondary | 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. | 1-4 weeks | No |