Status:
COMPLETED
Study Evaluating the Safety & Efficacy of DVS-223 SR for Relief of Vasomotor Symptoms Associated With Menopause
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Vasomotor Symptoms
Eligibility:
FEMALE
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
End Date :
April 1 2004
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT00421031
Start Date
December 1 2003
End Date
April 1 2004
Last Update
January 11 2007
Active Locations (41)
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1
Montgomery, Alabama, United States, 36116
2
Peoria, Arizona, United States, 85345
3
San Diego, California, United States, 92123
4
Stanford, California, United States, 94143