Effects of a Kappa Agonist on Hot Flashes in Menopausal Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of a Kappa Agonist on Hot Flashes in Menopausal Women

Conditions
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Treatment of Menopausal Hot Flashes

Intervention / Treatment
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* Drug: Standard Dose Kappa Agonist
* Drug: Half Dose Kappa Agonist
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Cornstarch, National Formulary | Other: Placebo<br> <br> |
| Experimental: Standard Dose Kappa Agonist<br>Pentazocine/Naloxone 50/0.5 mg | Drug: Standard Dose Kappa Agonist<br> <br> * Other names: Pentazocine/Naloxone 50/0.5 mg;|
| Experimental: Half Dose Kappa Agonist<br>Pentazocine/Naloxone 25/0.25 mg | Drug: Half Dose Kappa Agonist<br> <br> * Other names: Pentazocine/Naloxone 25/0.25 mg;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjectively measured hot flashes | 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. | 1-4 weeks | 
| Change in Serum Leutinizing Hormone | 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. | 1-4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hot flashes, menopause, kappa agonist