Clinical trial NCT01455597: Evaluate Long-Term Safety and Efficacy WC3011 (Estradiol Vaginal Cream)
Official title: A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in the Treatment of Symptoms of Vulvovaginal Atrophy in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vulvovaginal Atrophy
Keywords: Postmenopausal Women
Vaginal Dryness
Postmenopausal Vulvovaginal Atrophy
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
First posted: 2011-10-20
Enrollment: 309
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label extension study evaluating the long-term safety and efficacy of WC3011 in non-hysterectomized, healthy, postmenopausal women with vulvovaginal atrophy.


Eligibility criteria: Inclusion Criteria:

* Completed Study PR-04409.3 (NCT01400776)

Exclusion Criteria:

Developed any of the following during Study-PR04409.3 or has begun taking hormone therapy other than WC3011:

* Hypersensitivity to estrogen and/or progestin therapy
* Known or suspected premalignant or malignant disease (except successfully treated skin cancers)
* Manifestation of or treatment for significant cardiovascular disease, stroke or ischemic attack
* Insulin-dependent diabetes mellitus
* Smoking ≥ 15 cigarettes daily
* Uncontrolled hypertension - systolic blood pressure (BP) ≥ 160 mmHG or diastolic ≥ 95 mmHg

Primary outcomes:
measure: Number of Participants With Endometrial Biopsy Results at Final Visit
timeFrame: Final Visit (Day closest to Day 281)
Secondary outcomes:
measure: Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints
timeFrame: Baseline (Baseline/Visit 1 for this study was the same as Final Visit/Visit 5 for completers of PR-04409.3) to Weeks 4, 8, 16, 24, 32, 40 and Final Visit (Day closest to Day 281)
measure: Change From Baseline in Vaginal Cytology: Percentage of Superficial Vaginal Cells
timeFrame: Baseline (Baseline/Visit 1 for this study was the same as Final Visit/Visit 5 for completers of PR-04409.3) to Week 40 and Final Visit (Day closest to Day 281)
measure: Change From Baseline in Vaginal Cytology: Percentage of Parabasal Vaginal Cells
timeFrame: Baseline (Baseline/Visit 1 for this study was the same as Final Visit/Visit 5 for completers of PR-04409.3) to Week 40 and Final Visit (Day closest to Day 281)
measure: Change From Baseline in Vaginal pH
timeFrame: Baseline (Baseline/Visit 1 for this study was the same as Final Visit/Visit 5 for completers of PR-04409.3) to Week 40 and Final Visit (Day closest to Day 281)
measure: Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA
timeFrame: Baseline (Baseline/Visit 1 for this study was the same as Final Visit/Visit 5 for completers of PR-04409.3) to Week 40 and Final Visit (Day closest to Day 281)
measure: Number of Participants With At Least One Treatment Emergent Adverse Event (TEAE)
timeFrame: Up to Week 40
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Medical Affiliated Research Center, Inc.
state: Alabama
city: Mobile
country: United States
facility: Warner Chilcott Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Women's Health Research
state: Arizona
city: Phoenix
country: United States
facility: Precision Trials, LLC
state: Arizona
city: Scottsdale
country: United States
facility: Radiant Research-Scottsdale
state: Arizona
city: Tucson
country: United States
facility: Radiant Research-Tucson
state: Arizona
city: Tucson
country: United States
facility: Visions Clinical Research-Tucson
state: Arizona
city: San Diego
country: United States
facility: Genesis Center for Clinical Research
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: San Diego
country: United States
facility: Women's Healthcare Inc.
state: California
city: New London
country: United States
facility: Coastal Connecticut Research, LLC
state: Connecticut
city: Boynton Beach
country: United States
facility: Visions Clinical Research
state: Florida
city: Clearwater
country: United States
facility: Women's Medical Research Group, LLC
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Miami
country: United States
facility: New Age Medical Research Corp
state: Florida
city: Ormond Beach
country: United States
facility: Ormond Medical Arts Pharmaceutical Research Center
state: Florida
city: Palm Beach Gardens
country: United States
facility: OB-GYN Specialists of the Palm Beaches
state: Florida
city: Pinellas Park
country: United States
facility: Radiant Research-St. Petersburg
state: Florida
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Trials, LLC
state: Florida
city: Atlanta
country: United States
facility: Radiant Research-Atlanta
state: Georgia
city: Savannah
country: United States
facility: Fellows Research Alliance, Inc.
state: Georgia
city: Chicago
country: United States
facility: Radiant Research-Chicago
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinical, LLP
state: Illinois
city: Granger
country: United States
facility: The South Bend Clinic, LLP
state: Indiana
city: Overland Park
country: United States
facility: Radiant Research - Overland Park
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates
state: Kansas
city: Louisville
country: United States
facility: Bluegrass Clinical Research, Inc.
state: Kentucky
city: Marrero
country: United States
facility: York Clinical Consulting
state: Louisiana
city: New Orleans
country: United States
facility: Women Under Study
state: Louisiana
city: Kalamazoo
country: United States
facility: Beyer Research
state: Michigan
city: Chaska
country: United States
facility: Ridgeview Research
state: Minnesota
city: Las Vegas
country: United States
facility: Affiliated Clinical Research
state: Nevada
city: Las Vegas
country: United States
facility: Office of R. Garn Mabey, M.D.
state: Nevada
city: Lawrenceville
country: United States
facility: Lawrence OB-GYN Associates, P.C.
state: New Jersey
city: Moorestown
country: United States
facility: Phoenix OB-GYN Assoc., LLC
state: New Jersey
city: Plainsboro
country: United States
facility: Women's Health Research Center
state: New Jersey
city: Greensboro
country: United States
facility: Hawthorne Medical Research, Inc.
state: North Carolina
city: New Bern
country: United States
facility: Eastern Carolina Women's Center
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: Hawthorne Medical Research, Inc.
state: North Carolina
city: Winston-Salem
country: United States
facility: Lyndhurst Clinical Research
state: North Carolina
city: Cleveland
country: United States
facility: Rapid Medical Research, Inc.
state: Ohio
city: Columbus
country: United States
facility: The Columbus Center for Women's Health Research
state: Ohio
city: Eugene
country: United States
facility: Clinical Trials of America, Inc.
state: Oregon
city: Medford
country: United States
facility: Advanced Clinical Research
state: Oregon
city: Philadelphia
country: United States
facility: Philadelphia Clinical Research, LLC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Clinical Trials Research Services, LLC
state: Pennsylvania
city: Wexford
country: United States
facility: Susan L. Floyd, MD, PC
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Bluffton
country: United States
facility: Fellows Research Alliance, Inc.
state: South Carolina
city: Dallas
country: United States
facility: Practice Research Organization, Inc.
state: Texas
city: Dallas
country: United States
facility: Radiant Research-Dallas
state: Texas
city: Dallas
country: United States
facility: Research Across America
state: Texas
city: Houston
country: United States
facility: Advances In Health, Inc
state: Texas
city: San Antonio
country: United States
facility: Radiant Research-San Antonio
state: Texas
city: Webster
country: United States
facility: Center for Reproductive Medicine
state: Texas
city: Salt Lake City
country: United States
facility: J. Lewis Research-Foothill Family Clinic
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research - Foothill Family Clinic South
state: Utah
city: Sandy
country: United States
facility: Physicians' Research Options LLC
state: Utah
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
city: Richmond
country: United States
facility: Virginia Women's Center
state: Virginia
city: Seattle
country: United States
facility: Seattle Women's: Health, Research, Gynecology
state: Washington
city: Spokane
country: United States
facility: North Spokane Women's Clinic
state: Washington
Study officials:
affiliation: Allergan
name: Anna Chan, PharmD
role: STUDY_DIRECTOR
References: