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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00401245
Other study ID # 3151A2-405
Secondary ID
Status Completed
Phase Phase 3
First received November 17, 2006
Last updated October 24, 2011
Start date December 2006
Est. completion date January 2008

Study information

Verified date October 2011
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date January 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
desvenlafaxine succinate sustained release
Titration 100 mg
desvenlafaxine succinate sustained release
Titration 50 mg
desvenlafaxine succinate sustained release
Titration 25 mg, 50mg
desvenlafaxine succinate sustained release
Titration 25 mg
Placebo
Tapering placebo
desvenlafaxine succinate sustained release
Tapering 50 mg, placebo
desvenlafaxine succinate sustained release
Tapering 50 mg, 25 mg
desvenlafaxine succinate sustained release
Tapering 50 mg QOD

Locations

Country Name City State
Canada Pfizer Investigational Site Calgary Alberta
Canada Pfizer Investigational Site Coquitlam British Columbia
Canada Pfizer Investigational Site Langley British Columbia
Canada Pfizer Investigational Site Montreal Quebec
Canada Pfizer Investigational Site Newmarket Ontario
Canada Pfizer Investigational Site Pointe Claire Quebec
Canada Pfizer Investigational Site Quebec
Canada Pfizer Investigational Site Sarnia Ontario
Canada Pfizer Investigational Site Shawinigan Quebec
Canada Pfizer Investigational Site Sherbrooke Quebec
Canada Pfizer Investigational Site St-Romuald Quebec
Canada Pfizer Investigational Site St. John's Newfoundland and Labrador
Canada Pfizer Investigational Site Surrey British Columbia
Canada Pfizer Investigational Site Toronto Ontario
Canada Pfizer Investigational Site Toronto Ontario
Canada Pfizer Investigational Site Toronto Ontario
Canada Pfizer Investigational Site Unknown Quebec
Canada Pfizer Investigational Site Winnipeg Manitoba
Canada Pfizer Investigational Site Winnipeg Manitoba
United States Pfizer Investigational Site Albuquerque New Mexico
United States Pfizer Investigational Site Albuquerque New Mexico
United States Pfizer Investigational Site Beverly Hills California
United States Pfizer Investigational Site Billings Montana
United States Pfizer Investigational Site Bismarck North Dakota
United States Pfizer Investigational Site Canton Michigan
United States Pfizer Investigational Site Carrollton Texas
United States Pfizer Investigational Site Champaign Illinois
United States Pfizer Investigational Site Chapel Hill North Carolina
United States Pfizer Investigational Site Charlotte North Carolina
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Clearwater Florida
United States Pfizer Investigational Site Cleveland Ohio
United States Pfizer Investigational Site Crystal River Florida
United States Pfizer Investigational Site Deland Florida
United States Pfizer Investigational Site Denver Colorado
United States Pfizer Investigational Site Encinitas California
United States Pfizer Investigational Site Eugene Oregon
United States Pfizer Investigational Site Fargo North Dakota
United States Pfizer Investigational Site Foothill Ranch California
United States Pfizer Investigational Site Gainesville Florida
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Hurst Texas
United States Pfizer Investigational Site Idaho Falls Idaho
United States Pfizer Investigational Site Lake Worth Florida
United States Pfizer Investigational Site Las Vegas Nevada
United States Pfizer Investigational Site Lebanon New Hampshire
United States Pfizer Investigational Site Lexington Kentucky
United States Pfizer Investigational Site Longmont Colorado
United States Pfizer Investigational Site Louisville Kentucky
United States Pfizer Investigational Site Metairie Louisiana
United States Pfizer Investigational Site Metairie Louisiana
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Midland Texas
United States Pfizer Investigational Site New Brunswick New Jersey
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site Norfolk Virginia
United States Pfizer Investigational Site Norfolk Virginia
United States Pfizer Investigational Site Omaha Nebraska
United States Pfizer Investigational Site Palm Harbor Florida
United States Pfizer Investigational Site Pittsburgh Pennsylvania
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site Seattle Washington
United States Pfizer Investigational Site South Bend Indiana
United States Pfizer Investigational Site Tampa Florida
United States Pfizer Investigational Site Tucson Arizona
United States Pfizer Investigational Site Tucson Arizona
United States Pfizer Investigational Site Upland California
United States Pfizer Investigational Site Watertown South Dakota
United States Pfizer Investigational Site Winston-Salem North Carolina
United States Pfizer Investigational Site Winston-Salem North Carolina
United States Pfizer Investigational Site Ypsilanti Michigan

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Nausea During the First 2 Weeks of Treatment Nausea by spontaneous reports to the investigators was counted if it was reported during first 2 weeks of treatment, and it was not seen before the first dose of treatment, or if it was seen before the first dose and the symptoms got worse. If multiple incidences occurred on the same participant during the 2 weeks, only 1 incidence was counted. Baseline up to Week 2 Yes
Primary Discontinuation Emergent Signs and Symptoms (DESS) Total Score at the End of First Week of Tapering DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of "new symptoms" and "old (but worse) symptoms" (1) and 0 for "old and unchanged symptom", "absent", or "old symptom but improved" for a total possible range of 0 to 43. A higher score indicates more symptoms. Week 17 Yes
Primary DESS Total Score at End of Second Week of Tapering DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of "new symptoms" and "old (but worse) symptoms" (1) and 0 for "old and unchanged symptom", "absent", or "old symptom but improved" for a total possible range of 0 to 43. A higher score indicates more symptoms. Week 18 Yes
Primary DESS Total Score at 1 Week After the End of Tapering DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of "new symptoms" and "old (but worse) symptoms" (1) and 0 for "old and unchanged symptom", "absent", or "old symptom but improved" for a total possible range of 0 to 43. A higher score indicates more symptoms. Week 19 Yes
Secondary Number of Participants With Other Spontaneously Reported Adverse Events (AEs) in First 2 Weeks of Treatment Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship. Baseline up to Week 2 Yes
Secondary Percentage of Participants Discontinuing Treatment Due to AEs in First 2 Weeks of Treatment Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship. Baseline up to Week 2 Yes
Secondary Number of Participants With Each DESS at the End of First Week of Tapering DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. Week 17 Yes
Secondary Number of Participants With Each DESS at the End of Second Week of Tapering DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. Week 18 Yes
Secondary Number of Participants With Each DESS One Week After End of Tapering DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. Week 19 Yes
Secondary Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment Satisfaction with tolerability (lack of bothersomeness) was assessed using a questionnaire via an interactive voice response system (IVRS)/interactive web based response system (IWRS), and evaluated based on participants' response of extremely satisfied, satisfied, neutral, dissatisfied or extremely dissatisfied with the study medication. Week 1 and Week 2 No
Secondary Number of Participants Showing Satisfaction With Tolerability at the End of Tapering Satisfaction with tolerability (lack of bothersomeness) was assessed using a questionnaire via an IVRS/IWRS and evaluated based on participants' response of extremely satisfied, satisfied, neutral, dissatisfied or extremely dissatisfied with the study medication. Week 19 No
Secondary Menopause Symptoms-treatment Satisfaction Questionnaire (MS-TSQ) Score MS-TSQ is a questionnaire assessing participants' degree of satisfaction with regard to the test article which was administered to the participants via an IVRS/IWRS. The questionnaire comprised 8 questions and each was rated on a scale from 0 (extremely dissatisfied) to 4 (extremely satisfied). Week 16 No
Secondary Change From Baseline in Menopause-specific Quality of Life Questionnaire (MenQOL) Score at Week 4, Week 8, Week 12 and Week 16 MenQOL questionnaire assessed how bothered participants were with 31 symptoms. It contains domains: vasomotor (items 1-3); psychosocial (items 4-10); physical (items 11-26); sexual (items 27-29); in addition to nausea and indigestion. 31 individual symptoms are rated on a scale of 0 (not at all bothered) to 6 (extremely bothered). Total possible score ranged from 0 to 186. MenQOL summary score was calculated as mean of four domain scores (Physical function, Psychosocial function, Sexual function and Vasomotor function) ranging from 1 to 8, with higher scores indicating worse quality of life. Baseline, Week 4, Week 8, Week 12 and Week 16 No
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