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

Last updated on March 11, 2019

FOR MORE INFORMATION
Study Location
Montgomery, Alabama, 36116 United States
Contact
1-800-718-1021
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
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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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
The factors, or reasons, that prevent a person from participating in a clinical study.
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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.

NCT00421031
Pfizer
Completed
Study Evaluating the Safety & Efficacy of DVS-223 SR for Relief of Vasomotor Symptoms Associated With Menopause

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