Effects of a Kappa Agonist on Hot Flashes in Menopausal Women

Phase 1

Completed

• Conditions: Treatment of Menopausal Hot Flashes
• Interventions: Other: Placebo; Drug: Standard Dose Kappa Agonist; Drug: Half Dose Kappa Agonist

• Registration Number: NCT02070718
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Study First Submitted: 2014-02-21
• Study First Submitted QC: 2014-02-21
• Study First Posted: 2014-02-25
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-29
• Last Update Posted: 2015-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Cornstarch, National Formulary
Standard Dose Kappa Agonist	Standard Dose Kappa Agonist	Pentazocine/Naloxone 50/0.5 mg
Half Dose Kappa Agonist	Half Dose Kappa Agonist	Pentazocine/Naloxone 25/0.25 mg

Primary Outcome Measures

Name	Time	Method
Hot Flashes	1-4 weeks	Objectively measured hot flash frequency by changes in skin conductance over 8 hours on 3 separate study visits 3-14 days apart.

Secondary Outcome Measures

Name	Time	Method
Subjectively measured hot flashes	1-4 weeks	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.
Change in Serum Leutinizing Hormone	1-4 weeks	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.

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States