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

Depomed

Status and phase: Completed; Phase 2

Conditions: Hot Flashes

Treatments: Drug: Gabapentin Extended Release tablets; Drug: Gabapentin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00511953

81-0056

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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108 participants in 2 patient groups, including a placebo group

Gabapentin ER

Active Comparator group

Description:

Active drug, Gabapentin extended release

Treatment:

Drug: Gabapentin Extended Release tablets

Drug: Gabapentin

Sugar Pill

Placebo Comparator group

Description:

Comparator arm is Placebo

Treatment:

Drug: Gabapentin Extended Release tablets

Drug: Gabapentin