Effects of a Kappa Agonist on Hot Flashes in Menopausal Women
Completed · Phase 1 · Has a placebo group
Conditions studied: Treatment of Menopausal Hot Flashes
In brief
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.
Key facts
- Study ID
- NCT02070718
- Run by
- University of Washington
- People needed
- 12
- Starts
- 2013-01-01
- Expected to finish
- 2013-07-01
- Last updated by the study team
- 2015-07-01
Who can join
Age: 45 and older, up to 60. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Washington — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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