The Effect Of Dose Titration And Dose Tapering On The Tolerability Of DVS SR In Women With Vasomotor Symptoms - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00401245

Purpose

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. Nausea is the most common adverse event that is observed in clinical studies and is the main reason for discontinuation during the first week of therapy. Other adverse events (headache, nausea, and dizziness) associated with DVS SR have been noted to occur when subjects abruptly discontinue the medication. The purpose of this study is to evaluate several titration and tapering regimens of DVS SR to ensure a better tolerability profile at the start and completion of treatment. In addition, this study will provide a long posttreatment follow-up to assess any symptoms after treatment is discontinued.

Condition	Intervention	Phase
Vasomotor Symptoms	Drug: desvenlafaxine succinate sustained release	Phase III

MedlinePlus related topics: Menopause Nausea and Vomiting

Drug Information available for: Desvenlafaxine Desvenlafaxine Succinate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study
Official Title:	The Effect of Dose Titration and Dose Tapering on the Tolerability of DVS SR in Women With Vasomotor Symptoms Associated With Menopause: The PRIMMUS (PRIstiq for Managing Menopause and Understanding Symptoms) Study

Further study details as provided by Wyeth:

Primary Outcome Measures:

Incidence of nausea during the first 2 weeks of treatment. Discontinuation-Emergent Signs and Symptoms total score at the end of the first and second weeks of tapering and 1 week after the end of tapering. [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	500
Study Start Date:	November 2006
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	Drug: desvenlafaxine succinate sustained release Titration 100 mg/ Titration 50 mg/ Titration 25 mg, 50mg/ Titration 25 mg // Tapering None/ Tapering 50 mg, placebo/ Tapering 50 mg, 25 mg/ Tapering 50 mg QOD
B: Active Comparator	Drug: desvenlafaxine succinate sustained release Titration 100 mg/ Titration 50 mg/ Titration 25 mg, 50mg/ Titration 25 mg // Tapering None/ Tapering 50 mg, placebo/ Tapering 50 mg, 25 mg/ Tapering 50 mg QOD
C: Active Comparator	Drug: desvenlafaxine succinate sustained release Titration 100 mg/ Titration 50 mg/ Titration 25 mg, 50mg/ Titration 25 mg // Tapering None/ Tapering 50 mg, placebo/ Tapering 50 mg, 25 mg/ Tapering 50 mg QOD
D: Active Comparator	Drug: desvenlafaxine succinate sustained release Titration 100 mg/ Titration 50 mg/ Titration 25 mg, 50mg/ Titration 25 mg // Tapering None/ Tapering 50 mg, placebo/ Tapering 50 mg, 25 mg/ Tapering 50 mg QOD
E: Active Comparator	Drug: desvenlafaxine succinate sustained release Titration 100 mg/ Titration 50 mg/ Titration 25 mg, 50mg/ Titration 25 mg // Tapering None/ Tapering 50 mg, placebo/ Tapering 50 mg, 25 mg/ Tapering 50 mg QOD
F: Active Comparator	Drug: desvenlafaxine succinate sustained release Titration 100 mg/ Titration 50 mg/ Titration 25 mg, 50mg/ Titration 25 mg // Tapering None/ Tapering 50 mg, placebo/ Tapering 50 mg, 25 mg/ Tapering 50 mg QOD
G: Active Comparator	Drug: desvenlafaxine succinate sustained release Titration 100 mg/ Titration 50 mg/ Titration 25 mg, 50mg/ Titration 25 mg // Tapering None/ Tapering 50 mg, placebo/ Tapering 50 mg, 25 mg/ Tapering 50 mg QOD
H: Placebo Comparator	Drug: desvenlafaxine succinate sustained release Titration 100 mg/ Titration 50 mg/ Titration 25 mg, 50mg/ Titration 25 mg // Tapering None/ Tapering 50 mg, placebo/ Tapering 50 mg, 25 mg/ Tapering 50 mg QOD

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00401245

Show 43 Study Locations

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3151A2-405
Study First Received:	November 17, 2006
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00401245
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

O-desmethylvenlafaxine
Menopause

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs

Psychotropic Drugs
Central Nervous System Agents
Antidepressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2009