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

Last updated on December 15, 2017

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.
Show details

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.
Show details

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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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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Vasomotor Symptoms
Drug: DVS-233 SR
Not Provided
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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
540
April 2004
Not Provided

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.
Sexes Eligible for Study: Female
Child, Adult, Senior
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00421031
3151A2-315
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
January 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

BY EMAIL

Contact

[email protected]



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