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

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NCT00401245

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Study Location
Pfizer Investigational Site
Tucson, Arizona, 85710, United States
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1-800-718-1021
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Vasomotor Symptoms
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE The Effect Of Dose Titration And Dose Tapering On The Tolerability Of DVS SR In Women With Vasomotor Symptoms
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Vasomotor Symptoms
Intervention  ICMJE
  • Drug: desvenlafaxine succinate sustained release
    Titration 100 mg
  • Drug: desvenlafaxine succinate sustained release
    Titration 50 mg
  • Drug: desvenlafaxine succinate sustained release
    Titration 25 mg, 50mg
  • Drug: desvenlafaxine succinate sustained release
    Titration 25 mg
  • Drug: Placebo
    Tapering placebo
  • Drug: desvenlafaxine succinate sustained release
    Tapering 50 mg, placebo
  • Drug: desvenlafaxine succinate sustained release
    Tapering 50 mg, 25 mg
  • Drug: desvenlafaxine succinate sustained release
    Tapering 50 mg QOD
Study Arms  ICMJE
  • Active Comparator: A
    Intervention: Drug: desvenlafaxine succinate sustained release
  • Active Comparator: B
    Intervention: Drug: desvenlafaxine succinate sustained release
  • Active Comparator: C
    Intervention: Drug: desvenlafaxine succinate sustained release
  • Active Comparator: D
    Intervention: Drug: desvenlafaxine succinate sustained release
  • Active Comparator: E
    Intervention: Drug: Placebo
  • Active Comparator: F
    Intervention: Drug: desvenlafaxine succinate sustained release
  • Active Comparator: G
    Intervention: Drug: desvenlafaxine succinate sustained release
  • Placebo Comparator: H
    Intervention: Drug: desvenlafaxine succinate sustained release
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 17, 2006)		500
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00401245
Other Study ID Numbers  ICMJE 3151A2-405
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP