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

Completed · Phase 3

Conditions studied: Vasomotor Symptoms

In brief

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.

Key facts

Study ID

NCT00421031

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

540

Starts

2003-12-01

Expected to finish

2004-04-01

Last updated by the study team

2007-01-11

Who can join

Age: any. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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).
• 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.
• Subjects must have body mass index (BMI) less than or equal to 40 using the nomograph for BMI.

You may not qualify if…

• Hypersensitivity to venlafaxine (Effexor or Effexor XR).
• 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.
• History of a seizure disorder other than a single childhood febrile seizure.

Where it is running

• Study site — Montgomery, Alabama, United States
• Study site — Peoria, Arizona, United States
• Study site — San Diego, California, United States
• Study site — Stanford, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Newark, Delaware, United States
• Study site — Aventura, Florida, United States
• Study site — Fort Myers, Florida, United States
• Study site — Inverness, Florida, United States
• Study site — Miami, Florida, United States
• Study site — New Port Richey, Florida, United States
• Study site — Ocala, Florida, United States
• Study site — Orange City, Florida, United States
• Study site — Pinellas Park, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — West Venice, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Savannah, Georgia, United States
• Study site — Newburgh, Indiana, United States
• Study site — Lexington, Kentucky, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Portland, Maine, United States
• Study site — Chaska, Minnesota, United States
• Study site — Jackson, Mississippi, United States

Full record on ClinicalTrials.gov

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