Clinical trial NCT00401245: The Effect Of Dose Titration And Dose Tapering On The Tolerability Of DVS SR In Women With Vasomotor Symptoms
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vasomotor Symptoms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-11-20
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.


Eligibility 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.

Primary outcomes:
measure: Number of Participants With Nausea During the First 2 Weeks of Treatment
timeFrame: Baseline up to Week 2
measure: Discontinuation Emergent Signs and Symptoms (DESS) Total Score at the End of First Week of Tapering
timeFrame: Week 17
measure: DESS Total Score at End of Second Week of Tapering
timeFrame: Week 18
measure: DESS Total Score at 1 Week After the End of Tapering
timeFrame: Week 19
Secondary outcomes:
measure: Number of Participants With Other Spontaneously Reported Adverse Events (AEs) in First 2 Weeks of Treatment
timeFrame: Baseline up to Week 2
measure: Percentage of Participants Discontinuing Treatment Due to AEs in First 2 Weeks of Treatment
timeFrame: Baseline up to Week 2
measure: Number of Participants With Each DESS at the End of First Week of Tapering
timeFrame: Week 17
measure: Number of Participants With Each DESS at the End of Second Week of Tapering
timeFrame: Week 18
measure: Number of Participants With Each DESS One Week After End of Tapering
timeFrame: Week 19
measure: Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment
timeFrame: Week 1 and Week 2
measure: Number of Participants Showing Satisfaction With Tolerability at the End of Tapering
timeFrame: Week 19
measure: Menopause Symptoms-treatment Satisfaction Questionnaire (MS-TSQ) Score
timeFrame: Week 16
measure: Change From Baseline in Menopause-specific Quality of Life Questionnaire (MenQOL) Score at Week 4, Week 8, Week 12 and Week 16
timeFrame: Baseline, Week 4, Week 8, Week 12 and Week 16
Other outcomes:
measure: Mean Age of the Participants in Tapering Phase
timeFrame: Week 17
measure: Gender of the Participants in Tapering Phase
timeFrame: Week 17
Locations:
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Beverly Hills
country: United States
facility: Pfizer Investigational Site
state: California
city: Encinitas
country: United States
facility: Pfizer Investigational Site
state: California
city: Foothill Ranch
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Upland
country: United States
facility: Pfizer Investigational Site
state: California
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Longmont
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Clearwater
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Crystal River
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Deland
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Gainesville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Lake Worth
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Palm Harbor
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Idaho Falls
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Champaign
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: South Bend
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Metairie
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Metairie
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Canton
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Ypsilanti
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Billings
country: United States
facility: Pfizer Investigational Site
state: Montana
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Lebanon
country: United States
facility: Pfizer Investigational Site
state: New Hampshire
city: New Brunswick
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Albuquerque
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Chapel Hill
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Bismarck
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Fargo
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Eugene
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Watertown
country: United States
facility: Pfizer Investigational Site
state: South Dakota
city: Carrollton
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Hurst
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Midland
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Norfolk
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Coquitlam
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Langley
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Surrey
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: St. John's
country: Canada
facility: Pfizer Investigational Site
state: Newfoundland and Labrador
city: Newmarket
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Pointe Claire
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Shawinigan
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: St-Romuald
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: Pfizer Investigational Site
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: