Clinical trial NCT01816139: Multicenter Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women
Official title: A Randomized, Multicenter, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of WC3011 in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vulvovaginal Atrophy
Keywords: vaginal dryness
vaginal atrophy
estrogen
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
First posted: 2013-03-21
Enrollment: 576
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: The primary objective of this study is to compare the efficacy of WC3011 with placebo vaginal gel in postmenopausal women for the relief of vaginal dryness caused by vaginal atrophy as measured by self-assessment, vaginal pH and vaginal smear.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Moderate to severe vaginal dryness
* Postmenopausal meeting one of the following: 12 months spontaneous amenorrhea, 6 months spontaneous amenorrhea with serum Follicle-stimulating hormone (FSH) \> 40 milli-International Unit (mIU)/mL, 6 weeks postsurgical bilateral oophorectomy confirmed by surgical report, ultrasound or serum FSH \> 40 mIU/mL, 6 weeks postsurgical hysterectomy with ovary failure confirmed by serum FSH \> 40 mIU/mL
* Age ≥ 40 years or if bilateral oophorectomy ≥ 35 years
* Vaginal pH \>5.0
* Less than or equal 5% superficial cells on vaginal wall cytologic smear
* Normal breast exam; if \> 40 years, documentation of negative mammogram

Exclusion Criteria:

* Randomization in PR-04409, participation in clinical trial or use of investigational drug within 30 days prior to screening
* Smokes ≥ 15 cigarettes/day
* Known or suspected premalignant or malignant disease
* Cardiovascular disease, insulin-dependent diabetes mellitus, congestive heart failure, stroke or ischemic attack, thrombophlebitis or thromboembolic disorder
* Increased frequency/severity headaches with estrogen therapy
* Drug addiction/alcohol abuse within last 2 years
* Currently taking St. John's Wort or anticoagulant
* Uncontrolled hypertension or thyroid disorder, clinically significant depression or untreated urinary tract infection

Primary outcomes:
measure: Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Final Assessment
timeFrame: Baseline (Day 0) to final assessment (Up to Week 12)
measure: Change From Baseline in Vaginal pH to Final Assessment
timeFrame: Baseline (Day 0) to final assessment (Up to Week 12)
measure: Change From Baseline in the Percentage of Vaginal Superficial Cells to Final Assessment
timeFrame: Baseline (Day 0) to final assessment (Up to Week 12)
measure: Change From Baseline in the Percentage of Vaginal Parabasal Cells to Final Assessment
timeFrame: Baseline (Day 0) to final assessment (Up to Week 12)
Secondary outcomes:
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 Participants Self-Assessment of the Symptoms of VVA
timeFrame: Baseline (Day 0) to Weeks 2, 4, 8, 12 and Final Assessment
measure: Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity
timeFrame: Baseline (Day 0) and Weeks 2, 4, 8, 12 and Final Assessment
measure: Change From Baseline in the Investigator's Assessment of Each of the Signs of VVA to Week 12 and Final Assessment
timeFrame: Baseline (Day 0) to Week 12 and Final Assessment
measure: Change From Baseline in the Percentage of Vaginal Superficial Cells to Week 12
timeFrame: Baseline (Day 0) to Week 12
measure: Change From Baseline in the Percentage of Vaginal Parabasal Cells to Week 12
timeFrame: Baseline (Day 0) to Week 12
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Warner Chilcott Investigational Study Site
state: Alabama
city: Mobile
country: United States
facility: Warner Chilcott Investigational Study Site
state: Alabama
city: Phoenix
country: United States
facility: Warner Chilcott Investigational Study Site
state: Arizona
city: Scottsdale
country: United States
facility: Warner Chilcott Investigational Study Site
state: Arizona
city: Tucson
country: United States
facility: Warner Chilcott Investigational Study Site
state: Arizona
city: San Diego
country: United States
facility: Warner Chilcott Investigational Study Site
state: California
city: San Diego
country: United States
facility: Warner Chilcott Investigational Study Site
state: California
city: San Diego
country: United States
facility: Warner Chilcott Investigational Study Site
state: California
city: New London
country: United States
facility: Warner Chilcott Investigational Study Site
state: Connecticut
city: Boynton Beach
country: United States
facility: Warner Chilcott Investigational Study Site
state: Florida
city: Clearwater
country: United States
facility: Warner Chilcott Investigational Study Site
state: Florida
city: Jacksonville
country: United States
facility: Warner Chilcott Investigational Study Site
state: Florida
city: Miami
country: United States
facility: Warner Chilcott Investigational Study Site
state: Florida
city: Miami
country: United States
facility: Warner Chilcott Investigational Study Site
state: Florida
city: Ormond Beach
country: United States
facility: Warner Chilcott Investigational Study Site
state: Florida
city: Palm Beach Gardens
country: United States
facility: Warner Chilcott Investigational Study Site
state: Florida
city: Pinellas Park
country: United States
facility: Warner Chilcott Investigational Study Site
state: Florida
city: West Palm Beach
country: United States
facility: Warner Chilcott Investigational Study Site
state: Florida
city: Atlanta
country: United States
facility: Warner Chilcott Investigational Study Site
state: Georgia
city: Roswell
country: United States
facility: Warner Chilcott Investigational Study Site
state: Georgia
city: Savannah
country: United States
facility: Warner Chilcott Investigational Study Site
state: Georgia
city: Granger
country: United States
facility: Warner Chilcott Investigational Study Site
state: Indiana
city: Marrero
country: United States
facility: Warner Chilcott Investigational Study Site
state: Louisiana
city: New Orleans
country: United States
facility: Warner Chilcott Investigational Study Site
state: Louisiana
city: Kalamazoo
country: United States
facility: Warner Chilcott Investigational Study Site
state: Michigan
city: Las Vegas
country: United States
facility: Warner Chilcott Investigational Study Site
state: Nevada
city: Las Vegas
country: United States
facility: Warner Chilcott Investigational Study Site
state: Nevada
city: Moorestown
country: United States
facility: Warner Chilcott Investigational Study Site
state: New Jersey
city: Greensboro
country: United States
facility: Warner Chilcott Investigational Study Site
state: North Carolina
city: New Bern
country: United States
facility: Warner Chilcott Investigational Study Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Warner Chilcott Investigational Study Site
state: North Carolina
city: Cleveland
country: United States
facility: Warner Chilcott Investigational Study Site
state: Ohio
city: Columbus
country: United States
facility: Warner Chilcott Investigational Study Site
state: Ohio
city: Jenkintown
country: United States
facility: Warner Chilcott Investigational Study Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Warner Chilcott Investigational Study Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Warner Chilcott Investigational Study Site
state: Pennsylvania
city: Bluffton
country: United States
facility: Warner Chilcott Investigational Study Site
state: South Carolina
city: Dallas
country: United States
facility: Warner Chilcott Investigational Study Site
state: Texas
city: Dallas
country: United States
facility: Warner Chilcott Investigational Study Site
state: Texas
city: Dallas
country: United States
facility: Warner Chilcott Investigational Study Site
state: Texas
city: Houston
country: United States
facility: Warner Chilcott Investigational Study Site
state: Texas
city: San Antonio
country: United States
facility: Warner Chilcott Investigational Study Site
state: Texas
city: Salt Lake City
country: United States
facility: Warner Chilcott Investigational Study Site
state: Utah
city: Salt Lake City
country: United States
facility: Warner Chilcott Investigational Study Site
state: Utah
city: Norfolk
country: United States
facility: Warner Chilcott Investigational Study Site
state: Virginia
city: Richmond
country: United States
facility: Warner Chilcott Investigational Study Site
state: Virginia
city: Seattle
country: United States
facility: Warner Chilcott Investigational Study Site
state: Washington
city: Spokane
country: United States
facility: Warner Chilcott Investigational Study Site
state: Washington
Study officials:
affiliation: Warner Chilcott
name: Anna Chan, PharmD
role: STUDY_DIRECTOR
References: