Study of Gabapentin Extended Release (G-ER) in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women

Study Overview
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Brief Summary
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Depomed's Gabapentin Extended Release is an investigational, extended release formulation of gabapentin that is being studied for the treatment of hot flashes in postmenopausal women.

Detailed Description
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The primary objective of this clinical trial is to determine the optimal dose of Gabapentin ER in reducing the number and severity of hot flashes in postmenopausal women. Patients will be randomly assigned to Gabapentin ER or placebo, with a 1 in 4 chance of getting placebo. The total study investigational treatment duration after screening and baseline will be 13 weeks. The primary endpoint of the trial is to compare the number and severity of hot flashes during the investigational treatment compared to baseline. Sleep quality will also be evaluated.

Official Title
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A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study of the Pharmacokinetics (PK) and Pharmacodynamics (PD) of Gabapentin Extended Release (G-ER) Tablets in the Treatment of Vasomotor Symptoms in Postmenopausal Women

Conditions
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Hot Flashes

Intervention / Treatment
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* Drug: Gabapentin Extended Release tablets
* Drug: Gabapentin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Generally healthy, postmenopausal women who seek treatment for hot flashes. Patients using hormone replacement therapy (HRT) must be willing to discontinue treatment. Patients must be experiencing at least 7 moderate to severe hot flashes per day. Patient must be willing to commit to 3 (optionally 4) overnight stays at the study site that will include frequent blood sampling. Other inclusions apply. Exclusion Criteria: Patients with hypersensitivity to gabapentin. Patients with severe chronic diarrhea, chronic constipation, uncontrolled irritable bowel syndrome (IBS) or unexplained weight loss. Patients treated with estrogen pellets or injectable progestin drug therapy within 6 months. Other exclusions apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gabapentin ER<br>Active drug, Gabapentin extended release | Drug: Gabapentin Extended Release tablets<br>* 1800mg<br>Drug: Gabapentin<br>* 1800mg<br>|
| Placebo Comparator: Sugar Pill<br>Comparator arm is Placebo | Drug: Gabapentin Extended Release tablets<br>* 1800mg<br>Drug: Gabapentin<br>* 1800mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of moderate to severe hot flashes reported during the corresponding 24- hour blood samples collection period | PD end points are considered as primary outcomes of this study | 24hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGIC and PGIC evaluated prior to the start of 24- hour blood samples at week 6 and week 12 visits. | Efficacy variables | 12 wks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hot flashes, Hot flushes, Postmenopausal symptoms