Effects of a Kappa Agonist on Hot Flashes in Menopausal Women

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Washington
• Collaborators: 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); Office of Research on Women's Health (ORWH)
• Treatments: Naloxone; Pentazocine

Criteria

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