Clinical trial NCT02070718: Effects of a Kappa Agonist on Hot Flashes in Menopausal Women
Official title: Effects of a Kappa Agonist on Hot Flashes in Menopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Treatment of Menopausal Hot Flashes
Keywords: hot flashes
menopause
kappa agonist
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: National Center for Complementary and Integrative Health (NCCIH)
name: Office of Research on Women's Health (ORWH)
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2014-02-25
Enrollment: 12
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Hot Flashes
timeFrame: 1-4 weeks
Secondary outcomes:
measure: Subjectively measured hot flashes
timeFrame: 1-4 weeks
measure: Change in Serum Leutinizing Hormone
timeFrame: 1-4 weeks
Other outcomes:
measure: Serum Follicle Stimulating Hormone
timeFrame: Baseline only
measure: Serum Estradiol
timeFrame: Baseline only
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Susan D Reed, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oakley AE, Steiner RA, Chavkin C, Clifton DK, Ferrara LK, Reed SD. kappa Agonists as a novel therapy for menopausal hot flashes. Menopause. 2015 Dec;22(12):1328-34. doi: 10.1097/GME.0000000000000476.