Eight-Week Efficacy & Safety Study of Mesafem in the Treatment of VMS Associated With Menopause

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Noven Therapeutics

ClinicalTrials.gov Identifier:

NCT00786188

First received: November 4, 2008

Last updated: April 9, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

November 4, 2008

Last Updated Date

April 9, 2013

Start Date ^ICMJE

November 2008

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Mean change in frequency of moderate to severe VMS from baseline to Week 4 and Week 8 [ Time Frame: Week 4 and Week 8 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Mean change in frequency and severity of moderate to severe VMS from baseline to Week 4 and Week 8 [ Time Frame: Week 4 and Week 8 ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00786188 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change from baseline in climacteric symptoms at Week 8. [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Eight-Week Efficacy & Safety Study of Mesafem in the Treatment of VMS Associated With Menopause

Official Title ^ICMJE

A Phase 2, Exploratory, Eight-Week, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Mesafem Capsules in the Treatment of Vasomotor Symptoms Associated With Menopause

Brief Summary

This is an exploratory 8-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

Detailed Description

Eligible subjects will be entered into a 1-week observation period followed by a 1-week run-in period. Following completion of the run-in period, eligible subjects will be randomized to receive either Mesafem or placebo in a 1:1 ratio. Study drug will be administered once daily at bedtime. Symptom assessment questionnaires will be administered at baseline and at Day 28 and Day 57 visits.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Hot Flashes

Intervention ^ICMJE

Drug: Mesafem
Eligible subjects will be randomized to receive Mesafem capsule.

Other Name: Mesafem
Drug: Sugar pill
Subjects will receive a sugar pill.

Other Name: Sugar pill

Study Arm (s)

Experimental: Mesafem
Eligible subjects will be randomized to receive Mesafem capsules.

Intervention: Drug: Mesafem
Placebo Comparator: Placebo - Sugar Pill
Eligible subjects will be randomized to receive a sugar pill.

Intervention: Drug: Sugar pill

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

103

Completion Date

June 2009

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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:

History of hypersensitivity or adverse reaction to Mesafem
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

Gender

Female

Ages

41 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00786188

Other Study ID Numbers ^ICMJE

N30-002

Has Data Monitoring Committee

Responsible Party

Noven Therapeutics

Study Sponsor ^ICMJE

Noven Therapeutics

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Patrick F. Freuen, MD	North Spokane Women's Clinic, 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

Information Provided By

Noven Therapeutics

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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