Study Evaluating the Safety & Efficacy of DVS-223 SR for Relief of Vasomotor Symptoms Associated With Menopause
A Double-Blind, Randomized, Placebo-Controlled Efficacy and Safety Study of DVS-233 SR For Relief of Vasomotor Symptoms Associated With Menopause
1 other identifier
interventional
540
1 country
41
Brief Summary
The purpose of this study is to assess the efficacy and safety of 4 doses of desvenlafaxine-233 sustained release (DVS-233 SR) as compared to placebo for the treatment of moderate to severe vasomotor symptoms associated with menopause, as well as its influence on sleep parameters and other health outcomes indicators.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2003
Shorter than P25 for phase_3
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
January 10, 2007
CompletedFirst Posted
Study publicly available on registry
January 11, 2007
CompletedJanuary 11, 2007
January 1, 2007
January 10, 2007
January 10, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
The primary objective is to assess the efficacy and safety of 4 doses of DVS-233 SR as compared to placebo for the treatment of moderate to severe VMS associated with menopause.
Secondary Outcomes (1)
The secondary objectives are to assess the effects of DVS-233 SR as compared to placebo on sleep parameters and on health outcomes indicators
Interventions
Eligibility Criteria
You may qualify if:
- Generally healthy, postmenopausal women; at least 12 months of spontaneous amenorrhea or at least 6 months of spontaneous amenorrhea with serum FSH levels \> 40 mIU/mL or at least 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy).
- Minimum of 7 moderate to severe hot flushes per day or 50 moderate to severe hot flushes per week at screening:
- Moderate hot flush: warm sensation with sweating, does not disrupt activity.
- Severe hot flush: hot sensation with sweating, disrupts activity.
- Subjects must have body mass index (BMI) less than or equal to 40 using the nomograph for BMI.
You may not qualify if:
- Hypersensitivity to venlafaxine (Effexor or Effexor XR).
- Use of oral estrogen-, progestin-, androgen-, or SERM-containing drug products within 8 weeks prior to screening; use of transdermal hormone products within 8 weeks prior to screening; use of vaginal hormone products (rings, creams, gels) within 4 weeks prior to screening; use of intrauterine progestins within 8 weeks prior to screening; use of progestin implants or estrogen injectables within 3 months prior to screening; use of estrogen pellet or progestin injectables within 6 months prior to screening.
- History of a seizure disorder other than a single childhood febrile seizure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
Unknown Facility
Montgomery, Alabama, 36116, United States
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Peoria, Arizona, 85345, United States
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San Diego, California, 92123, United States
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Stanford, California, 94143, United States
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Colorado Springs, Colorado, 80907, United States
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Newark, Delaware, 19713, United States
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Aventura, Florida, 33160, United States
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Fort Myers, Florida, 33990, United States
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Inverness, Florida, 34452, United States
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Miami, Florida, 33143, United States
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New Port Richey, Florida, 32701, United States
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Ocala, Florida, 34470, United States
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Orange City, Florida, 32763, United States
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Pinellas Park, Florida, 33781, United States
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Tampa, Florida, 33709, United States
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West Palm Beach, Florida, 33409, United States
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West Venice, Florida, 34285, United States
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Atlanta, Georgia, 30342, United States
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Savannah, Georgia, 31405, United States
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Newburgh, Indiana, 47630, United States
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Lexington, Kentucky, 40536, United States
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Shreveport, Louisiana, 71103, United States
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Portland, Maine, 04102, United States
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Chaska, Minnesota, 55387, United States
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Jackson, Mississippi, 39216, United States
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St Louis, Missouri, 63131, United States
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Billings, Montana, 59101, United States
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Las Vegas, Nevada, 89119, United States
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Reno, Nevada, 89509, United States
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Albuquerque, New Mexico, 87102, United States
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Albuquerque, New Mexico, 87131, United States
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Winston-Salem, North Carolina, 27103, United States
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Canton, Ohio, 44406, United States
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Cincinnati, Ohio, 45249, United States
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Cincinnati, Ohio, 45267, United States
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Portland, Oregon, 97201, United States
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Erie, Pennsylvania, 16502, United States
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Wexford, Pennsylvania, 15090, United States
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Greenville, South Carolina, 29605, United States
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San Antonio, Texas, 78229, United States
Unknown Facility
Norfolk, Virginia, 23507, United States
Related Publications (1)
Speroff L, Gass M, Constantine G, Olivier S; Study 315 Investigators. Efficacy and tolerability of desvenlafaxine succinate treatment for menopausal vasomotor symptoms: a randomized controlled trial. Obstet Gynecol. 2008 Jan;111(1):77-87. doi: 10.1097/01.AOG.0000297371.89129.b3.
PMID: 18165395DERIVED
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 10, 2007
First Posted
January 11, 2007
Study Start
December 1, 2003
Study Completion
April 1, 2004
Last Updated
January 11, 2007
Record last verified: 2007-01