Clinical trial NCT01400776: Safety & Efficacy WC3011 (Estradiol Vaginal Cream) in the Treatment of Vulvovaginal Atrophy in Postmenopausal Women
Official title: A Randomized, Double-Blind, Vehicle-Controlled Study of the 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: Postmenopausal Vulvovaginal Atrophy
Keywords: Postmenopausal Women, Vaginal Dryness
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
First posted: 2011-07-22
Enrollment: 722
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study if WC3011 is effective and safe in the treatment of postmenopausal vaginal dryness due to vulvovaginal atrophy.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal females ≥35 years with either or both ovaries removed or naturally menopausal with moderate to severe vaginal dryness

Exclusion Criteria:

* 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, congestive heart failure, stroke or ischemic attacks
* Insulin-dependent diabetes mellitus
* Increased frequency or severity of headaches while on hormone or estrogen therapy
* Drug or alcohol addiction within last 2 years
* Participation in a clinical trial within 30 days
* Smoking ≥ 15 cigarettes daily
* Uncontrolled hypertension - systolic blood pressure (BP) ≥ 160 mmHg or diastolic BP ≥ 95 mmHg

Primary outcomes:
measure: Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Week 12/Final Visit
timeFrame: Baseline (Day 0) to Week 12/Final Visit
measure: Change From Baseline in Vaginal pH to Week 12/Final Visit
timeFrame: Baseline (Day 0) to Week 12/Final Visit
measure: Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12/Final Visit
timeFrame: Baseline (Day 0) to Week 12/Final Visit
measure: Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12/Final Visit
timeFrame: Baseline (Day 0) to Week 12/Final Visit
Secondary outcomes:
measure: Change From Baseline in Investigator's Assessment of Atrophy to Week 12 and Week 12/Final Visit
timeFrame: Baseline (Day 0) to Week 12 and Week 12/Final visit
measure: Change From Baseline in Investigator's Assessment of Pallor to Week 12 and Week 12/Final Visit
timeFrame: Baseline (Day 0) to Week 12 and Week 12/Final visit
measure: Change From Baseline in Investigator's Assessment of Vaginal Dryness to Week 12 and Week 12/Final Visit
timeFrame: Baseline (Day 0) to Week 12 and Week 12/Final visit
measure: Change From Baseline in Investigator's Assessment of Friability to Week 12 and Week 12/Final Visit
timeFrame: Baseline (Day 0) to Week 12 and Week 12/Final visit
measure: Change From Baseline in Investigator's Assessment of Petechiae to Week 12 and Week 12/Final Visit
timeFrame: Baseline (Day 0) to Week 12 and Week 12/Final visit
measure: Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Weeks 2, 4, 8 and 12
timeFrame: Baseline (Day 0) to Weeks 2, 4, 8 and 12
measure: Change From Baseline in Participant's Self-Assessment of Vaginal and/or Vulvar Irritation/Itching to Weeks 2, 4, 8, 12 and Week 12/Final Visit
timeFrame: Baseline (Day 0) to Weeks 2, 4, 8, 12 and Week 12/Final visit
measure: Change From Baseline in Participant's Self-Assessment of Dysuria (Painful or Difficult Urination) to Weeks 2, 4, 8, 12 and Week 12/Final Visit
timeFrame: Baseline (Day 0) to Weeks 2, 4, 8, 12 and Week 12/Final visit
measure: Change From Baseline in Participant's Self-Assessment of Dyspareunia (Pain Associated With Sexual Activity) to Weeks 2, 4, 8, 12 and Week 12/Final Visit
timeFrame: Baseline (Day 0) to Weeks 2, 4, 8, 12 and Week 12/Final visit
measure: Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity as Per Participant's Self-Assessment to Weeks 2, 4, 8, 12 and Week 12/Final Visit
timeFrame: Baseline (Day 0) and Weeks 2, 4, 8, 12 and Week 12/Final visit
measure: Change From Baseline in Vaginal pH to Week 12
timeFrame: Baseline (Day 0) to Week 12
measure: Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12
timeFrame: Baseline (Day 0) to Week 12
measure: Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12
timeFrame: Baseline (Day 0) to Week 12
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Medical Affiliated Research Center, Inc.
state: Alabama
city: Mobile
country: United States
facility: Mobile OB-GYN, PC
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: Lakewood
country: United States
facility: Physicians' Research Options LLC
state: Colorado
city: New London
country: United States
facility: Costal Connecticut Resarch, 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
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: Decatur
country: United States
facility: Soapstone Center for Clinical Research
state: Georgia
city: Roswell
country: United States
facility: Atlanta North Gynecology, PC
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: Bardstown
country: United States
facility: Kentucky Pediatric Research, Inc.
state: Kentucky
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 Two Twelve Medical Center
state: Minnesota
city: Las Vegas
country: United States
facility: Affiliated Clinical Research
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: The Center for Women's Health and Wellness, LLC
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: Englewood
country: United States
facility: HWC - Women's Research Center
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: Jenkintown
country: United States
facility: The Clinical Trial Center, LLC
state: Pennsylvania
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: Columbia
country: United States
facility: SC Clinical Research Center, LLC
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 RHD Professional Plaza 4
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: