Clinical trial NCT00361569: A Clinical Trial to Evaluate the Safety and Efficacy of DR-2041(Synthetic Conjugated Estrogens, A) for Treatment of Vulvovaginal Atrophy
Official title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Compare the Effects of 12 Weeks of Treatment With DR-2041(Synthetic Conjugated Estrogens, A) Vaginal Cream vs. Placebo Vaginal Cream on Vulvovaginal Atrophy in Healthy Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Menopause
Keywords: vaginal atrophy
vaginal dryness
vaginal itching
vaginal pain
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2006-08-08
Enrollment: 622
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 four-arm, randomized, double-blind, parallel group, placebo-controlled study to compare the effects of two doses of DR-2041(Synthetic Conjugated Estrogens, A) Vaginal Cream on vulvovaginal atrophy in postmenopausal women with or without a hysterectomy and/or oophorectomy.

Detailed description: The study will include a screening period up to 4 weeks and a 12- week treatment period. The overall study duration for participants will be approximately 16 weeks. Study participants will undergo physical and gynecological exams, and blood tests for clinical laboratory assessments. All patients with a uterus will undergo transvaginal ultrasound.

Eligibility criteria: Inclusion Criteria:

* Naturally or surgically menopausal
* Moderate or severe symptoms of vaginal atrophy (ie, dryness, itching, pain, uncomfortable intercourse)

Exclusion Criteria:

* Known sensitivity or contraindication to estrogens or progestins
* History or current diagnosis endometrial hyperplasia
* Recent history of vaginal bleeding of unknown cause
* Recent history or diagnosis of endometriosis
* Any contraindication to estrogen therapy

Primary outcomes:
measure: Mean Change in the Symptom Identified by the Patient to be Most Bothersome
timeFrame: Baseline to Week 12
measure: Mean Change in Vaginal pH
timeFrame: Baseline to Week 12
measure: Mean Change in Maturation Index
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Safety and Tolerability of DR-2041 (Synthetic Conjugated Estrogens, A)
timeFrame: Up to Week 12
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Duramed Investigational Site
state: Alabama
city: Mobile
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: 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: Fresno
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: Colorado Springs
country: United States
facility: Duramed Investigational Site
state: Colorado
city: Pueblo
country: United States
facility: Duramed Investigational Site
state: Colorado
city: New London
country: United States
facility: Duramed Investigational Site
state: Connecticut
city: Clearwater
country: United States
facility: Duramed Investigational Site
state: Florida
city: Clearwater
country: United States
facility: Duramed Investigational Site
state: Florida
city: Gainesville
country: United States
facility: Duramed Investigational Site
state: Florida
city: Jacksonville
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: Pinellas Park
country: United States
facility: Duramed Investigational Site
state: Florida
city: Stuart
country: United States
facility: Duramed Investigational Site
state: Florida
city: Tampa
country: United States
facility: Duramed Investigational Site
state: Florida
city: Tampa
country: United States
facility: Duramed Investigational Site
state: Florida
city: Venice
country: United States
facility: Duramed Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Duramed Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Duramed Investigational Site
state: Florida
city: Weston
country: United States
facility: Duramed Investigational Site
state: Florida
city: Alpharetta
country: United States
facility: Duramed Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Duramed Investigational Site
state: Georgia
city: Augusta
country: United States
facility: Duramed Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Duramed Investigational Site
state: Georgia
city: Douglasville
country: United States
facility: Duramed Investigational Site
state: Georgia
city: Sandy Springs
country: United States
facility: Duramed Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Duramed Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Duramed Investigational Site
state: Illinois
city: Evansville
country: United States
facility: Duramed Investigational Site
state: Indiana
city: Overland Park
country: United States
facility: Duramed Investigational Site
state: Kansas
city: Lexington
country: United States
facility: Duramed Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Duramed Investigational Site
state: Kentucky
city: Madisonville
country: United States
facility: Duramed Investigational Site
state: Kentucky
city: Shreveport
country: United States
facility: Duramed Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: Duramed Investigational Site
state: Maryland
city: Livonia
country: United States
facility: Duramed Investigational Site
state: Michigan
city: Lincoln
country: United States
facility: Duramed Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: Duramed Investigational Site
state: Nevada
city: Lebanon
country: United States
facility: Duramed Investigational Site
state: New Hampshire
city: Lawrenceville
country: United States
facility: Duramed Investigational Site
state: New Jersey
city: Moorestown
country: United States
facility: Duramed Investigational Site
state: New Jersey
city: New Brunswick
country: United States
facility: Duramed Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Duramed Investigational Site
state: New Mexico
city: Johnson City
country: United States
facility: Duramed Investigational Site
state: New York
city: Williamsville
country: United States
facility: Duramed Investigational Site
state: New York
city: Raleigh
country: United States
facility: Duramed Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Duramed Investigational Site
state: North Carolina
city: Jamestown
country: United States
facility: Duramed Investigational Site
state: North Dakota
city: Minot
country: United States
facility: Duramed Investigational Site
state: North Dakota
city: Cincinnati
country: United States
facility: Duramed Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Duramed Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Duramed Investigational Site
state: Ohio
city: Columbus
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: Portland
country: United States
facility: Duramed Investigational Site
state: Oregon
city: Portland
country: United States
facility: Duramed Investigational Site
state: Oregon
city: Allentown
country: United States
facility: Duramed Investigational Site
state: Pennsylvania
city: King of Prussia
country: United States
facility: Duramed Investigational Site
state: Pennsylvania
city: Media
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: Rosemont
country: United States
facility: Duramed Investigational Site
state: Pennsylvania
city: Strafford
country: United States
facility: Duramed Investigational Site
state: Pennsylvania
city: Warwick
country: United States
facility: Duramed Investigational Site
state: Rhode Island
city: Charleston
country: United States
facility: Duramed Investigational Site
state: South Carolina
city: Charleston
country: United States
facility: Duramed Investigational Site
state: South Carolina
city: Columbia
country: United States
facility: Duramed Investigational Site
state: South Carolina
city: Watertown
country: United States
facility: Duramed Investigational Site
state: South Dakota
city: Memphis
country: United States
facility: Duramed Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Duramed Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Duramed Investigational Site
state: Texas
city: Austin
country: United States
facility: Duramed Investigational Site
state: Texas
city: Corpus Christi
country: United States
facility: Duramed Investigational Site
state: Texas
city: Dallas
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: Houston
country: United States
facility: Duramed Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Duramed Investigational Site
state: Texas
city: Waco
country: United States
facility: Duramed Investigational Site
state: Texas
city: Williston
country: United States
facility: Duramed Investigational Site
state: Vermont
city: Newport News
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 Protocol Chair
role: STUDY_CHAIR
References:
citation: Freedman M, Kaunitz AM, Reape KZ, Hait H, Shu H. Twice-weekly synthetic conjugated estrogens vaginal cream for the treatment of vaginal atrophy. Menopause. 2009 Jul-Aug;16(4):735-41. doi: 10.1097/gme.0b013e318199e734.