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

Phase 2CompletedNCT00511953

Depomed108 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

108

Conditions

Hot Flashes

Interventions

Gabapentin Extended Release tabletsDRUG

1800mg

GabapentinDRUG

1800mg

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Generally healthy, postmenopausal women who seek treatment for hot flashes. 2. Patients using hormone replacement therapy (HRT) must be willing to discontinue treatment. 3. Patients must be experiencing at least 7 moderate to severe hot flashes per day. 4. 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: 1. Patients with hypersensitivity to gabapentin. 2. Patients with severe chronic diarrhea, chronic constipation, uncontrolled irritable bowel syndrome (IBS) or unexplained weight loss. 3. Patients treated with estrogen pellets or injectable progestin drug therapy within 6 months. Other exclusions apply.

Locations (8)

Unnamed facility

Burbank, California, United States

Unnamed facility

DeLand, Florida, United States

Unnamed facility

Port Orange, Florida, United States

Unnamed facility

Shawnee, Kansas, United States

Outcomes

Primary Outcomes

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

Time frame: 24hrs

Secondary Outcomes

CGIC and PGIC evaluated prior to the start of 24- hour blood samples at week 6 and week 12 visits.

Efficacy variables

Time frame: 12 wks

Data from ClinicalTrials.gov

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