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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00511953

Enrollment

108

Registered

2007-08-06

Start date

2007-06-30

Completion date

2008-02-29

Last updated

2011-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hot Flashes

Keywords

Hot flashes, Hot flushes, Postmenopausal symptoms

Brief summary

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

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.

Interventions

DRUGGabapentin Extended Release tablets

1800mg

DRUGGabapentin

1800mg

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026