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

PHASE3CompletedINTERVENTIONAL
Enrollment

565

Participants

Timeline

Start Date

October 31, 2008

Primary Completion Date

July 31, 2009

Study Completion Date

October 31, 2009

Conditions
Hot Flashes
Interventions
DRUG

Gabapentin Extended-Release (G-ER) 1200 mg

G-ER 1200 mg daily dosage given as two 600-mg tablets.

DRUG

Gabapentin Extended-Release (G-ER) 1800 mg

G-ER 1800 mg daily dosage given as one 600-mg tablet in the morning and two 600-mg tablets in the evening.

DRUG

Placebo

Matching placebo dosages of 1200 mg daily (two 600-mg tablets) and 1800 mg daily (one 600-mg tablet in the morning and two 600-mg tablets in the evening).

Trial Locations (45)

11211

Williamsburg Boro Park ObGyn, PC, New York

19046

The Clinical Trial Center, LLC, Jenkintown

27262

Pinewest Ob-Gyn, Inc., High Point

29464

Coastal Carolina Research Center, Inc., Mt. Pleasant

29615

Upstate Pharmaceutical Research, Greenville

30134

Atlanta West Women's Center, Douglasville

30342

Atlanta Women's Research Institute, Inc., Atlanta

32607

Southeastern Integrated Medical, PL, Gainsville

33024

University Clinical Research, Inc., Pembroke Pines

33319

Sunrise Medical Research, Lauderdale Lakes

33765

Clinical Research of West Florida, Inc., Clearwater

33781

Radiant Research - St. Petersburg, Pinellas Park

34203

Meridien Research, Bradenton

34601

Meridien Research, Brooksville

35209

Radiant Research, Birmingham

37043

Alpha Clinical Research, LLC, Clarksville

37923

Clinical Research Investigative Services, LLC, Knoxville

38120

Mid-South OB-GYN, PLLC, Memphis

43213

Columbus Center for Women's Health Research, Columbus

44122

Rapid Medical Research, Inc., Cleveland

45249

Radiant Research, Inc., Cincinnati

46250

Physician's Research Group, Indianapolis

48604

Saginaw Valley Medical Research Group, LLC, Saginaw

49079

Women's Health Care Specialists, PC, Paw Paw

55108

Aspen Medical Group, Saint Paul

58501

Mid Dakota Clinic, PC, Bismarck

70072

West Bank Women's Health, Marrero

72205

May Women's Health Clinic, Little Rock

75235

Renaissance Clinical Research and Hypertension Clinic, Dallas

78217

InVisions Consultants, LLC, San Antonio

80112

Milestone Medical Research, Inc., Englewood

84088

Advanced Clinical Research, West Jordan

84107

Radiant Research, Inc., Salt Lake City

85225

Star W Research, Chandler

85251

Radiant Research, Scottsdale

89104

Clinical Research Center of Nevada, Las Vegas

92103

Genesis Center for Clinical Research, San Diego

San Diego

92108

Medical Center for Clinical Research, San Diego

92610

Family Medical Center, Foothill Ranch

97401

Clinical Trials of America, Inc., Eugene

97504

PMG/OB Gyn Health Center, Medford

06810

Danbury Clinical Research, LLC, Danbury

06460

Clinical Research Consulting, LLC, Milford

01830

ActivMed Practices and Research, Haverhill

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Depomed

INDUSTRY

NCT00777023 - Study of Gabapentin Extended Release (G-ER)in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women. | Biotech Hunter | Biotech Hunter