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Completed

NCT Number: NCT00511953

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

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.

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Key information

Conditions

Hot Flashes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Burbank, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gabapentin Extended Release tablets

Drug

1800mg

Gabapentin

Drug

1800mg

Primary outcomes

  1. Frequency of moderate to severe hot flashes reported during the corresponding 24- hour blood samples collection period

    Time frame: 24hrs

    PD end points are considered as primary outcomes of this study

Secondary outcomes

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

    Time frame: 12 wks

    Efficacy variables

Sponsors and collaborators

Lead sponsor

Depomed

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
Aug 6, 2007
Registry last updated
Jun 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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