24-Week Efficacy & Safety Study of Mesafem Capsules in the Treatment of VMS - Full Text View

Purpose

To assess the safety and efficacy of Mesafem for treatment of vasomotor symptoms (VMS) associated with menopause

Condition	Intervention	Phase
Hot Flashes	Drug: Mesafem Capsules or Placebo Capsules	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 3, Twenty-Four Week, Multicenter, Double-Blind, Randomized, Placebo- Controlled, Efficacy and Safety Study of Mesafem (Paroxetine Mesylate) Capsules in the Treatment of Vasomotor Symptoms Associated With Menopause

Resource links provided by NLM:

MedlinePlus related topics: Menopause Women's Health

U.S. FDA Resources

Further study details as provided by Noven Therapeutics:

Primary Outcome Measures:

Mean change in frequency & severity of moderate to severe vasomotor symptoms from baseline [ Time Frame: Week 4, Week 12, and Week 24 ] [ Designated as safety issue: No ]

Enrollment:	570
Study Start Date:	March 2010
Study Completion Date:	November 2011
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Mesafem Capsules Experimental	Drug: Mesafem Capsules or Placebo Capsules Eligible subjects will be randomized to receive either Mesafem or placebo capsules in a 1:1 ratio. Other Name: Mesafem Capsules

Detailed Description:

The study is a 24-week, multicenter, double-blind, randomized, placebo-controlled study of Mesafem capsules in subjects with moderate to severe postmenopausal VMS, defined as follows:

Moderate VMS: Sensation of heat with sweating, able to continue activity
Severe VMS: Sensation of heat with sweating, causing cessation of activity

The study is comprised of a screening period, a run-in period, a baseline visit, and a double-blind treatment period.

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Female, >40 years of age
Reported more than 7-8 moderate to severe hot flashes per day (average) or 50-60 moderate to severe hot flashes per week for at least 30 days prior
Spontaneous amenorrhea for at least 12 consecutive months
Amenorrhea for at least 6 months and meet the biochemical criteria for menopause
Bilateral salpingo-oophorectomy >6 weeks with or without hysterectomy

Exclusion Criteria:

BMI ≥ 40 kg/m²
Known non-responder to previous SSRI or SNRI treatment for VMS
History of self-injurious behavior
History of clinical diagnosis of depression; or treatment for depression
History of clinical diagnosis of borderline personality disorder
Use of an investigational study medication within 30 days prior to screening or during the study
Concurrent participation in another clinical trial or previous participation in this trial
Family of investigational-site staff

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01101841

Show 32 Study Locations

Sponsors and Collaborators

Noven Therapeutics

Investigators

Principal Investigator:	Derrick R Havin, MD	North Spokane Women's Clinic Research, Spokane, WA 99207
Principal Investigator:	Richard E Hedrick, MD	Hawthorne Medical Research, Inc., Winston-Salem, NC 27103
Principal Investigator:	Samuel N Lederman, MD	Altus Research, Lake Worth, FL 33461
Principal Investigator:	Larry S Seidman, DO	Philadelphia Clinical Research, LLC, Philadelphia, PA 19114
Principal Investigator:	James E Tomblin, MD	Hawthorne Medical Research, Inc., Greensboro, NC 27408
Principal Investigator:	Peter A Zedler, MD	Virginia Women's Center, Richmond, VA 23233
Principal Investigator:	D S Harnsberger, MD	Chattanooga Medical Research, LLC, Chattanooga, TN 37404
Principal Investigator:	John A Hoekstra, MD	National Clinical Research, Inc., Richmond, VA 23294
Principal Investigator:	Robin Kroll, MD	Women's Clinical Research Center, Seattle, WA 98105
Principal Investigator:	Ashley Tunkle, MD	Anchor Research Center, Naples, FL 34102
Principal Investigator:	Matthew Davis, MD	Rochester Clinical Research, Rochester, NY 14609
Principal Investigator:	Donna DeSantis, MD	East Valley Family Physicians PLC, Chandler, AZ 85224
Principal Investigator:	Steven Drosman	Genesis Center For Clinical Research, San Diego, CA 92103
Principal Investigator:	Mildred Farmer, MD	Meridien Research, Brooksville, FL 34601
Principal Investigator:	Sandra Hurtado, MD	The Woman's Hospital of Texas Clinical Research Center, Houston, TX 77054
Principal Investigator:	Bruce Levine, MD	Phoenix Ob-Gyn Associates, LLC, Moorestown, NJ 08057
Principal Investigator:	Tyrone Malloy, MD	Soapstone Center for Clinical Research, Decatur, GA 30034
Principal Investigator:	Eric Ross, MD	Apex Research Institute, Santa Ana, CA 92705
Principal Investigator:	Cynthia Strout, MD	Coastal Carolina Research Center, Mt. Pleasant, SC 29464
Principal Investigator:	Arthur Waldbaum, MD	Downtown Women's Health Care, Denver, CO, 80218
Principal Investigator:	Edward Zbella, MD	Women's Medical Research Group, LLC, Clearwater, FL 33759
Principal Investigator:	James R Dockery, MD	Montgomery Women's Health Associates, PC, Montgomery, AL 36116
Principal Investigator:	Stephen C Blank, MD	Mount Vernon Clinical Research, LLC, Sandy Springs, GA 30328
Principal Investigator:	Keith Aqua, MD	Visions Clinical Research, Boynton Beach, FL 33472
Principal Investigator:	Saul R Berg, MD	Clinical Trials Research Services, LLC, Pittsburgh, PA 15206
Principal Investigator:	Marvin Kalafer, MD	The Clinical Trial Center, LLC, Jenkintown, PA 19046
Principal Investigator:	David J Portman, MD	Columbus Center for Women's Health Research, Columbus, Ohio 43213
Principal Investigator:	Stephen Swanson, MD	Women's Clinic of Lincoln, PC, Lincoln, NE 68510
Principal Investigator:	Joseph Soufer, MD	Chase Medical Research, LLC, Waterbury, CT 06708
Principal Investigator:	ShaH R Scott, MD	Clinical Research Associates, Inc., Nashville, TN 37203
Principal Investigator:	Mary K Neuffer, MD	SC Clinical Research Center, LLC, Columbia, SC 29201
Principal Investigator:	Ronald Ackerman, MD	Comprehensive Clinical Trials, LLC, West Palm Beach, FL 33409

More Information

Additional Information:

Sponsor

This link exits the ClinicalTrials.gov site

Publications:

Fugate SE, Church CO. Nonestrogen treatment modalities for vasomotor symptoms associated with menopause. Ann Pharmacother. 2004 Sep;38(9):1482-99. Epub 2004 Aug 3. Review.

Kritz-Silverstein D, Goldani Von Mühlen D, Barrett-Connor E. Prevalence and clustering of menopausal symptoms in older women by hysterectomy and oophorectomy status. J Womens Health Gend Based Med. 2000 Sep;9(7):747-55.

Nelson HD, Vesco KK, Haney E, Fu R, Nedrow A, Miller J, Nicolaidis C, Walker M, Humphrey L. Nonhormonal therapies for menopausal hot flashes: systematic review and meta-analysis. JAMA. 2006 May 3;295(17):2057-71. Review.

Greene JG. A factor analytic study of climacteric symptoms. J Psychosom Res. 1976;20(5):425-30. No abstract available.

Responsible Party:	Noven Therapeutics
ClinicalTrials.gov Identifier:	NCT01101841 History of Changes
Other Study ID Numbers:	N30-004
Study First Received:	April 8, 2010
Last Updated:	April 9, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Noven Therapeutics:

Vasomotor Symptoms
Menopause
Hot Flashes

Perimenopause
Nonhormonal therapies
Climacteric symptoms

Additional relevant MeSH terms:

Hot Flashes
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013