Study Evaluating the Safety & Efficacy of DVS-223 SR for Relief of Vasomotor Symptoms Associated With Menopause

A Double-Blind, Randomized, Placebo-Controlled Efficacy and Safety Study of DVS-233 SR For Relief of Vasomotor Symptoms Associated With Menopause

The purpose of this study is to assess the efficacy and safety of 4 doses of desvenlafaxine-233 sustained release (DVS-233 SR) as compared to placebo for the treatment of moderate to severe vasomotor symptoms associated with menopause, as well as its influence on sleep parameters and other health outcomes indicators.

Study Overview

• Status: Completed
• Conditions: Vasomotor Symptoms
• Intervention / Treatment: Drug: DVS-233 SR

• Study Type: Interventional
• Enrollment: 540
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Montgomery, Alabama, United States, 36116
  • Arizona
    • Peoria, Arizona, United States, 85345
  • California
    • San Diego, California, United States, 92123
    • Stanford, California, United States, 94143
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
  • Delaware
    • Newark, Delaware, United States, 19713
  • Florida
    • Aventura, Florida, United States, 33160
    • Ft. Myers, Florida, United States, 33990
    • Inverness, Florida, United States, 34452
    • Miami, Florida, United States, 33143
    • New Port Richey, Florida, United States, 32701
    • Ocala, Florida, United States, 34470
    • Orange City, Florida, United States, 32763
    • Pinellas Park, Florida, United States, 33781
    • Tampa, Florida, United States, 33709
    • West Palm Beach, Florida, United States, 33409
    • West Venice, Florida, United States, 34285
  • Georgia
    • Atlanta, Georgia, United States, 30342
    • Savannah, Georgia, United States, 31405
  • Indiana
    • Newburgh, Indiana, United States, 47630
  • Kentucky
    • Lexington, Kentucky, United States, 40536
  • Louisiana
    • Shreveport, Louisiana, United States, 71103
  • Maine
    • Portland, Maine, United States, 04102
  • Minnesota
    • Chaska, Minnesota, United States, 55387
  • Mississippi
    • Jackson, Mississippi, United States, 39216
  • Missouri
    • St. Louis, Missouri, United States, 63131
  • Montana
    • Billings, Montana, United States, 59101
  • Nevada
    • Las Vegas, Nevada, United States, 89119
    • Reno, Nevada, United States, 89509
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
    • Albuquerque, New Mexico, United States, 87131
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
  • Ohio
    • Canton, Ohio, United States, 44406
    • Cincinnati, Ohio, United States, 45249
    • Cincinnati, Ohio, United States, 45267
  • Oregon
    • Portland, Oregon, United States, 97201
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16502
    • Wexford, Pennsylvania, United States, 15090
  • South Carolina
    • Greenville, South Carolina, United States, 29605
  • Texas
    • San Antonio, Texas, United States, 78229
  • Virginia
    • Norfolk, Virginia, United States, 23507

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Generally healthy, postmenopausal women; at least 12 months of spontaneous amenorrhea or at least 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL or at least 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy).

2. Minimum of 7 moderate to severe hot flushes per day or 50 moderate to severe hot flushes per week at screening:

   • Moderate hot flush: warm sensation with sweating, does not disrupt activity.
   • Severe hot flush: hot sensation with sweating, disrupts activity.
3. Subjects must have body mass index (BMI) less than or equal to 40 using the nomograph for BMI.

Exclusion Criteria:

1. Hypersensitivity to venlafaxine (Effexor or Effexor XR).
2. Use of oral estrogen-, progestin-, androgen-, or SERM-containing drug products within 8 weeks prior to screening; use of transdermal hormone products within 8 weeks prior to screening; use of vaginal hormone products (rings, creams, gels) within 4 weeks prior to screening; use of intrauterine progestins within 8 weeks prior to screening; use of progestin implants or estrogen injectables within 3 months prior to screening; use of estrogen pellet or progestin injectables within 6 months prior to screening.
3. History of a seizure disorder other than a single childhood febrile seizure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary objective is to assess the efficacy and safety of 4 doses of DVS-233 SR as compared to placebo for the treatment of moderate to severe VMS associated with menopause.

Secondary Outcome Measures

Outcome Measure
The secondary objectives are to assess the effects of DVS-233 SR as compared to placebo on sleep parameters and on health outcomes indicators

Collaborators and Investigators

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Publications and helpful links

General Publications

• Speroff L, Gass M, Constantine G, Olivier S; Study 315 Investigators. Efficacy and tolerability of desvenlafaxine succinate treatment for menopausal vasomotor symptoms: a randomized controlled trial. Obstet Gynecol. 2008 Jan;111(1):77-87. doi: 10.1097/01.AOG.0000297371.89129.b3.

Study record dates

Study Major Dates

• Study Start: December 1, 2003
• Study Completion: April 1, 2004

Study Registration Dates

• First Submitted: January 10, 2007
• First Submitted That Met QC Criteria: January 10, 2007
• First Posted (Estimate): January 11, 2007

Study Record Updates

• Last Update Posted (Estimate): January 11, 2007
• Last Update Submitted That Met QC Criteria: January 10, 2007
• Last Verified: January 1, 2007

More Information

Terms related to this study

• Other Study ID Numbers: 3151A2-315