Status:
COMPLETED
The Effect Of Dose Titration And Dose Tapering On The Tolerability Of DVS SR In Women With Vasomotor Symptoms
Lead Sponsor:
Pfizer
Conditions:
Vasomotor Symptoms
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
Desvenlafaxine succinate (DVS SR) is a serotonin and norepinephrine reuptake inhibitor (SNRI). It is a nonhormonal option for the treatment of Vasomotor Symptoms (VMS) associated with menopause. Nause...
Eligibility Criteria
Inclusion
- Generally healthy, postmenopausal woman who seeks treatment for hot flushes.
- Meets 1 of the following: At least 12 months of spontaneous amenorrhea; At least 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels \> 40 mIU/mL; At least 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy). Hysterectomized without bilateral oophorectomy and with serum FSH levels \>40 mIU/mL.
Exclusion
- History of a seizure disorder other than a single childhood febrile seizure.
- History or presence of clinically important hepatic or renal disease or other medical disease.
- Presence or recent history of major depressive disorder, bipolar disorder, psychotic disorder, or generalized anxiety disorder requiring therapy.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00401245
Start Date
December 1 2006
End Date
January 1 2008
Last Update
October 26 2011
Active Locations (74)
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1
Pfizer Investigational Site
Tucson, Arizona, United States, 85710
2
Pfizer Investigational Site
Tucson, Arizona, United States, 85715
3
Pfizer Investigational Site
Beverly Hills, California, United States, 90211
4
Pfizer Investigational Site
Encinitas, California, United States, 92024