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| ID | Type | Description | Link |
|---|---|---|---|
| GYN-01-2012 | Other Identifier | University of Washington |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Cornstarch, National Formulary |
|
| Standard Dose Kappa Agonist | Experimental | Pentazocine/Naloxone 50/0.5 mg |
|
| Half Dose Kappa Agonist | Experimental | Pentazocine/Naloxone 25/0.25 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Dose Kappa Agonist | Drug |
|
| |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Follicle Stimulating Hormone | Baseline (1st visit) single time point | Baseline only |
| Serum Estradiol | Baseline (1st visit) single time point only. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan D Reed, MD, MPH | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25988798 | Derived | 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. |
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| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010423 | Pentazocine |
| D009270 | Naloxone |
| ID | Term |
|---|---|
| D001575 | Benzomorphans |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Office of Research on Women's Health (ORWH) | NIH |
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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| Half Dose Kappa Agonist |
| Drug |
|
|
| Placebo | Other |
|
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 |
| Baseline only |
| D006571 |
| Heterocyclic Compounds |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |