Clinical trial NCT00272935: A Clinical Trial to Demonstrate the Efficacy and Safety of Cenestin 0.3 mg for the Treatment of Hot Flashes
Official title: A Randomized, Multicenter, Double-blind, Placebo-controlled Trial to Demonstrate the Safety and Efficacy of Daily 0.3 mg Synthetic Conjugated Estrogens, A (Cenestin) for the Treatment of Vasomotor Symptoms in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hot Flashes
Keywords: menopause
vasomotor symptoms
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2006-01-09
Enrollment: 400
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind study to compare the efficacy and safety of daily doses of Cenestin 0.3 mg tablets to placebo in reducing the frequency and severity of moderate to severe hot flashes in postmenopausal women.

Detailed description: The overall study duration will be approximately 16 weeks. After a screening/baseline period of up to 4 weeks patients will be randomized to receive either placebo tablets or Cenestin 0.3mg tablets

Eligibility criteria: Inclusion Criteria:

* Naturally or surgically postmenopausal
* At least 12 months since last menses or 6 weeks past surgery
* Minimum of 7 daily or 50 weekly moderate to severe hot flashes

Exclusion Criteria:

* Any contraindication to natural or synthetic estrogens

Primary outcomes:
measure: Mean change in average frequency of moderate to severe hot flashes
timeFrame: Baseline to Day 28 and to Day 84
measure: Mean change in severity of moderate to severe hot flashes
timeFrame: Baseline to Day 28 and to Day 84
Secondary outcomes:
measure: Safety and tolerability of Cenestin 0.3mg
timeFrame: Throughout study
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Duramed Investigational Site
state: Alabama
city: Montgomery
country: United States
facility: Duramed Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Duramed Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Duramed Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Duramed Investigational Site
state: Arizona
city: Carmichael
country: United States
facility: Duramed Investigational Site
state: California
city: Irvine
country: United States
facility: Duramed Investigational Site
state: California
city: San Diego
country: United States
facility: Duramed Investigational Site
state: California
city: San Diego
country: United States
facility: Duramed Investigational Site
state: California
city: San Diego
country: United States
facility: Duramed Investigational Site
state: California
city: San Ramon
country: United States
facility: Duramed Investigational Site
state: California
city: Brooksville
country: United States
facility: Duramed Investigational Site
state: Florida
city: Coral Gables
country: United States
facility: Duramed Investigational Site
state: Florida
city: Gainesville
country: United States
facility: Duramed Investigational Site
state: Florida
city: Leesburg
country: United States
facility: Duramed Investigational Site
state: Florida
city: Miami
country: United States
facility: Duramed Investigational Site
state: Florida
city: Palm Springs
country: United States
facility: Duramed Investigational Site
state: Florida
city: Venice
country: United States
facility: Duramed Investigational Site
state: Florida
city: Alpharetta
country: United States
facility: Duramed Investigational Site
state: Georgia
city: Douglasville
country: United States
facility: Duramed Investigational Site
state: Georgia
city: Boise
country: United States
facility: Duramed Investigational Site
state: Idaho
city: Evansville
country: United States
facility: Duramed Investigational Site
state: Indiana
city: Lexington
country: United States
facility: Duramed Investigational Site
state: Kentucky
city: Baltimore
country: United States
facility: Duramed Investigational Site
state: Maryland
city: Lincoln
country: United States
facility: Duramed Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: Duramed Investigational Site
state: Nevada
city: Albuquerque
country: United States
facility: Duramed Investigational Site
state: New Mexico
city: Cleveland
country: United States
facility: Duramed Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Duramed Investigational Site
state: Ohio
city: Mayfield Heights
country: United States
facility: Duramed Investigational Site
state: Ohio
city: Medford
country: United States
facility: Duramed Investigational Site
state: Oregon
city: King of Prussia
country: United States
facility: Duramed Investigational Site
state: Pennsylvania
city: North Wales
country: United States
facility: Duramed Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Duramed Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Duramed Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Duramed Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Duramed Investigational Site
state: South Carolina
city: Bristol
country: United States
facility: Duramed Investigational Site
state: Tennessee
city: Clarksville
country: United States
facility: Duramed Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Duramed Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Duramed Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Duramed Investigational Site
state: Texas
city: Houston
country: United States
facility: Duramed Investigational Site
state: Texas
city: Houston
country: United States
facility: Duramed Investigational Site
state: Texas
city: Houston
country: United States
facility: Duramed Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Duramed Investigational Site
state: Texas
city: Norfolk
country: United States
facility: Duramed Investigational Site
state: Virginia
city: Spokane
country: United States
facility: Duramed Investigational Site
state: Washington
city: Tacoma
country: United States
facility: Duramed Investigational Site
state: Washington
Study officials:
affiliation: Duramed Research, Inc
name: Duramed Research Protocol Chair
role: STUDY_CHAIR
References: