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

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00421031
• Collaborator: (none)
• Enrollment: 540
• Locations: 41
• Duration (Months): 4
• Patients Per Site: 13.2
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Vasomotor Symptoms	Drug: DVS-233 SR	Phase 3

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Double-Blind, Randomized, Placebo-Controlled Efficacy and Safety Study of DVS-233 SR For Relief of Vasomotor Symptoms Associated With Menopause
• Study Start Date: Dec 1, 2003
• Study Completion Date: Apr 1, 2004

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

1. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Montgomery	Alabama	United States	36116
2		Peoria	Arizona	United States	85345
3		San Diego	California	United States	92123
4		Stanford	California	United States	94143
5		Colorado Springs	Colorado	United States	80907
6		Newark	Delaware	United States	19713
7		Aventura	Florida	United States	33160
8		Ft. Myers	Florida	United States	33990
9		Inverness	Florida	United States	34452
10		Miami	Florida	United States	33143
11		New Port Richey	Florida	United States	32701
12		Ocala	Florida	United States	34470
13		Orange City	Florida	United States	32763
14		Pinellas Park	Florida	United States	33781
15		Tampa	Florida	United States	33709
16		West Palm Beach	Florida	United States	33409
17		West Venice	Florida	United States	34285
18		Atlanta	Georgia	United States	30342
19		Savannah	Georgia	United States	31405
20		Newburgh	Indiana	United States	47630
21		Lexington	Kentucky	United States	40536
22		Shreveport	Louisiana	United States	71103
23		Portland	Maine	United States	04102
24		Chaska	Minnesota	United States	55387
25		Jackson	Mississippi	United States	39216
26		St. Louis	Missouri	United States	63131
27		Billings	Montana	United States	59101
28		Las Vegas	Nevada	United States	89119
29		Reno	Nevada	United States	89509
30		Albuquerque	New Mexico	United States	87102
31		Albuquerque	New Mexico	United States	87131
32		Winston-Salem	North Carolina	United States	27103
33		Canton	Ohio	United States	44406
34		Cincinnati	Ohio	United States	45249
35		Cincinnati	Ohio	United States	45267
36		Portland	Oregon	United States	97201
37		Erie	Pennsylvania	United States	16502
38		Wexford	Pennsylvania	United States	15090
39		Greenville	South Carolina	United States	29605
40		San Antonio	Texas	United States	78229
41		Norfolk	Virginia	United States	23507

Sponsors and Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

• Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00421031
• Other Study ID Numbers: 3151A2-315
• First Posted: Jan 11, 2007
• Last Update Posted: Jan 11, 2007
• Last Verified: Jan 1, 2007

Study Results

No Results Posted as of Jan 11, 2007