Effects of a Kappa Agonist on Hot Flashes in Menopausal Women

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.

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