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Vasomotor SymptomsPhase 3NCT00421031

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

A Phase 3 study testing DVS-233 SR in people with Vasomotor Symptoms, run by Wyeth is now a wholly owned subsidiary of Pfizer at 41 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Vasomotor Symptoms
What is being tested?
DVS-233 SR
How many people
540 participants
Where
41 sitesUnited States
Study dates
Dec 2003to Apr 2004
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

41 sites in 1 country.

41 sites in 1 country

United States41 sites

  • Study site

    Albuquerque, New Mexico, 87102

  • Study site

    Albuquerque, New Mexico, 87131

  • Study site

    Atlanta, Georgia, 30342

  • Study site

    Aventura, Florida, 33160

  • Study site

    Billings, Montana, 59101

  • Study site

    Canton, Ohio, 44406

  • Study site

    Chaska, Minnesota, 55387

  • Study site

    Cincinnati, Ohio, 45249

  • Study site

    Cincinnati, Ohio, 45267

  • Study site

    Colorado Springs, Colorado, 80907

  • Study site

    Erie, Pennsylvania, 16502

  • Study site

    Fort Myers, Florida, 33990

  • Study site

    Greenville, South Carolina, 29605

  • Study site

    Inverness, Florida, 34452

  • Study site

    Jackson, Mississippi, 39216

  • Study site

    Las Vegas, Nevada, 89119

  • Study site

    Lexington, Kentucky, 40536

  • Study site

    Miami, Florida, 33143

  • Study site

    Montgomery, Alabama, 36116

  • Study site

    New Port Richey, Florida, 32701

  • Study site

    Newark, Delaware, 19713

  • Study site

    Newburgh, Indiana, 47630

  • Study site

    Norfolk, Virginia, 23507

  • Study site

    Ocala, Florida, 34470

  • Study site

    Orange City, Florida, 32763

  • Study site

    Peoria, Arizona, 85345

  • Study site

    Pinellas Park, Florida, 33781

  • Study site

    Portland, Maine, 04102

  • Study site

    Portland, Oregon, 97201

  • Study site

    Reno, Nevada, 89509

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Diego, California, 92123

  • Study site

    Savannah, Georgia, 31405

  • Study site

    Shreveport, Louisiana, 71103

  • Study site

    St Louis, Missouri, 63131

  • Study site

    Stanford, California, 94143

  • Study site

    Tampa, Florida, 33709

  • Study site

    West Palm Beach, Florida, 33409

  • Study site

    West Venice, Florida, 34285

  • Study site

    Wexford, Pennsylvania, 15090

  • Study site

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

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

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.

Being tested
DVS-233 SR

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DVS-233 SRDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 outcomes (1)

  1. The secondary objectives are to assess the effects of DVS-233 SR as compared to placebo on sleep parameters and on health outcomes indicators

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2007 (estimated)
  2. Study startDec 2003
  3. Study completionApr 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Enrolment
540 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00421031
Sponsor's protocol ID
3151A2-315
Status last verified
Jan 2007
First submitted
10 Jan 2007
Last updated
11 Jan 2007
Results posted
No

Publications

  • 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.

    PubMed 18165395

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DVS-233 SR in people with Vasomotor Symptoms, run by Wyeth is now a wholly owned subsidiary of Pfizer at 41 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00421031, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2007.

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