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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00421031
First received: January 10, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Vasomotor Symptoms
Drug: DVS-233 SR
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled Efficacy and Safety Study of DVS-233 SR For Relief of Vasomotor Symptoms Associated With Menopause

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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

Estimated Enrollment: 540
Study Start Date: December 2003
Estimated Study Completion Date: April 2004
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00421031

  Show 41 Study Locations
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00421031     History of Changes
Other Study ID Numbers: 3151A2-315
Study First Received: January 10, 2007
Last Updated: January 10, 2007
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 30, 2014