Clinical Trials Logo
  1. Home
  2. Menopause
  3. NCT00256685
  4. Details
NCT00256685 Clinical Trial

Study Evaluating DVS-233 SR to Treat Vasomotor Systems Associated With Menopause

Menopause Clinical Trial

Official title:
A Double-Blind, Randomized, Placebo-Controlled Efficacy and Safety Study of DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00256685
Other study ID # 3151A2-319
Secondary ID
Status Completed
Phase Phase 3
First received November 17, 2005
Last updated May 17, 2006
Start date September 2004
Est. completion date July 2005

Study information
Verified date May 2006
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety and efficacy of desvenlafaxine succinate (DVS) for treatment of moderate to severe vasomotor symptoms (VMS) that are associated with menopause, and also to assess the effects of DVS on sleep parameters and health outcomes indicators.

Recruitment information / eligibility
Status Completed
Enrollment 568
Est. completion date July 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- Generally healthy, postmenopausal women who seek treatment for hot flushes

- Minimum of 7 moderate to severe hot flushes per day or 50 per week recorded for 7 consecutive days during screening

- Body Mass Index (BMI) less than or equal to 40 kg/m2

Other inclusions apply.

Exclusion Criteria:

- Hypersensitivity to Venlafaxine

- History of seizure disorder

- History of myocardial infarction or unstable angina within 6 months

Other exclusions apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• DVS-233 SR

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary Reduction in average daily number of moderate & severe hot flushes and average daily severity score at weeks 4 & 12
Secondary Sleep, mood
See also
  Status Clinical Trial Phase
Completed NCT04553029 - A Survey Evaluating Prevalence, Severity and Associated Factors in East Asian Women With Moderate-to-severe Menopause-related Vasomotor Symptoms (MR-VMS)
Completed NCT03672513 - Short-term Supplementation, Bone Turnover and Antioxidant Status in Menopause N/A
Terminated NCT03642119 - Validation of an Objective Instrument to Measure Hot Flashes During Menopause
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Completed NCT04210583 - RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity N/A
Completed NCT06057896 - Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
Completed NCT05617287 - An Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Perimenopause and Menopause N/A
Recruiting NCT05180266 - Therapeutic Touch and Music in The Menopausal Period N/A
Recruiting NCT04043520 - Bioenergetic Effects of Aging and Menopause (BEAM) Phase 4
Completed NCT03663075 - Effect of Group Education and Individual Counselling on Mental Health and Quality of Life in 45-60 Year Old Women N/A
Completed NCT03363997 - Pharmacokinetics and Pharmacodynamics of 3 Dosages of Estriol After Continuous Vaginal Administration for 21 Days Phase 1
Not yet recruiting NCT04724135 - Assessment of Menopause Related Quality of Life Among Health Professionals in University Hospitals of UMC in Nur-Sultan
Not yet recruiting NCT04728126 - Menopausal Symptoms and Burnout: Comparison of Occupational Health Issue Among Health Professionals in UMC Hospitals
Completed NCT02274571 - Raising Insulin Sensitivity in Post Menopause Early Phase 1
Completed NCT02253173 - Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women Phase 3
Completed NCT02430987 - Low Sexual Desire and Metabolic Syndrome N/A
Completed NCT01757340 - Calorie Restriction With Leucine Supplementation N/A
Recruiting NCT01488903 - A Cohort Research of Genetic Susceptibility for Common Obesity in Women N/A
Terminated NCT01633814 - Hormone Replacement and Neural Cardiovascular Control in Postmenopausal Women N/A
Completed NCT00599456 - Investigation of the Usefulness of Omega 3 Vitamins in the Relief of Hot Flashes in Menopausal Women. N/A