Status:
COMPLETED
Study of Gabapentin Extended Release (G-ER) in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women
Lead Sponsor:
Depomed
Conditions:
Hot Flashes
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
Brief Summary
Depomed's Gabapentin Extended Release (G-ER) 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 study objective is to assess the efficacy of G-ER dosed in either of the following regimens: * G-ER 1200 mg daily (single evening dose) * G-ER 1800 mg daily (dosed asymmetrically; 600 mg ...
Eligibility Criteria
Inclusion
- Postmenopausal women aged 18 to 70 years experiencing ≥7 moderate to severe hot flashes per day (or ≥50 per week) accompanied by sweating during previous 30 days or longer.
- Had amenorrhea for ≥12 months, amenorrhea for 6 to 12 months with serum follicle-stimulating hormone (FSH) levels \>40 mIU/mL, or was ≥6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
- Willing to discontinue the following: vaginal hormonal products; transdermal or oral estrogen or estrogen/progestin combination; intrauterine progestin; progestin implants; injectable estrogen; topical progesterone cream.
- Had to have daily average of ≥7 moderate to severe hot flashes and had to complete ≥4 days of diary entries during baseline week to be randomized.
- If treated with antidepressants, could not have had any changes in drug doses during past month.
- Other Inclusions apply.
Exclusion
- Patient treated with a gonadotrophin releasing hormone agonist, anti-estrogens, or aromatase inhibitors within 2 months prior to study entry.
- Patient treated with estrogen pellets or progestin injectable drugs within 6 months prior to study entry.
- Patient experience only nighttime hot flashes or worked night shifts on a regular basis.
- Patient was concurrently treated with gabapentin for other indications. If patient was using gabapentin for treatment of hot flashes, she could be screened after a 7-day washout period provided hot flashes returned.
- Patient had previously experienced dose-limiting adverse events that prevented titration of gabapentin to an effective dose.
- Patient had a hypersensitivity to gabapentin.
- Patient was in an immunocompromised state.
- Patient had a malignancy other than basal cell carcinoma within 2 years prior to study entry.
- Patient had gastric reduction surgery, severe chronic diarrhea, chronic constipation, uncontrolled irritable bowel syndrome, uncontrolled inflammatory bowel disease, or unexplained weight loss.
- Patient had clinically significant abnormal chemistry or hematology results, or calculated glomerular filtration rate \<60 mL/min.
- Patient had history of substance abuse within year prior to study entry.
- Patient was concurrently taking morphine.
- Patient had history of chronic hepatitis B or C, hepatitis within 3 months prior to study entry, or history of human immunodeficiency virus.
- Other Exclusions apply.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
541 Patients enrolled
Trial Details
Trial ID
NCT00755417
Start Date
September 1 2008
End Date
October 1 2009
Last Update
March 7 2012
Active Locations (45)
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Birmingham, Alabama, United States
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Montgomery, Alabama, United States
3
Tempe, Arizona, United States
4
Tucson, Arizona, United States