Clinical trial NCT01845649: Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women With Dyspareunia
Official title: A Randomized, Multicenter, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of WC3011 in Postmenopausal Women With Dyspareunia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vulvovaginal Atrophy
Keywords: Vulvovaginal Atrophy
Dyspareunia
Postmenopausal
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
First posted: 2013-05-03
Enrollment: 550
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 purpose of the study is to determine if WC3011 is safe and effective in treating the symptom of painful intercourse secondary to vulvovaginal atrophy as measured by participant self-assessment when compared to vehicle.


Eligibility criteria: Inclusion Criteria:

* Sexually active with self-identified dyspareunia (pain with sexual activity), at least moderate to severe and most bothersome symptom of vulvovaginal atrophy (VVA)
* Postmenopausal and meets 1 of the following: 12 months spontaneous amenorrhea, 6 months spontaneous amenorrhea with FSH (follicle stimulating hormone) \>40 mIU/mL,6 weeks postsurgical bilateral oophorectomy with confirmation by FSH \>40 mIU/mL, surgical report or ultrasound, 6 weeks postsurgical hysterectomy with ovary failure confirmed by FSH \>40 mIU/mL
* Age ≥40 years; ≥35 with bilateral oophorectomy
* Vaginal pH \>5.0
* Less than or equal to 5% superficial cells on vaginal wall cytologic smear
* Normal clinical breast exam or negative mammogram if ≥ 40 years of age
* Negative urine pregnancy test (non-hysterectomized and \<12 months amenorrhea)

Exclusion Criteria:

* Enrollment in Sponsor's Study PR-04409 or PR-05812
* Participation in clinical trial or use of investigational drug within 30 days prior to screening
* Known hypersensitivity to estrogen and/or progestin therapy
* Known or suspected premalignant or malignant disease or history steroid-dependent malignancy
* Manifestation or treatment for significant cardiovascular disease (congestive heart failure, stroke or ischemic attack, myocardial infarction, coronary artery bypass, percutaneous angioplasty or \>50% angiographic narrowing of coronary artery
* Thrombophlebitis or thromboembolic disorder or history of
* Insulin-dependent diabetes mellitus
* Increased frequency or severity of headaches while on hormone or estrogen therapy
* Currently taking St. John's Wort
* Drug/alcohol addiction within past 2 years
* Treatment with anticoagulants (heparin or warfarin)
* Smoking ≥15 cigarettes/day

Primary outcomes:
measure: Change From Baseline in Participant's Self-Assessment of Symptom of Vulvovaginal Atrophy (VVA): Dyspareunia (Pain Associated With Sexual Activity) 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 the Symptom of VVA: Dyspareunia to Weeks 2, 4, 8, and 12
timeFrame: Baseline to Weeks 2, 4, 8 and 12
measure: Change From Baseline in Participant's Self-Assessment of the Other Symptoms of VVA to Weeks 2, 4, 8, 12, and Final Assessment
timeFrame: Baseline (Day 0) to Weeks 2, 4, 8, 12, and final assessment (Up to Week 12)
measure: Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity at Each Visit
timeFrame: Baseline (Day 0), Weeks 2, 4, 8, 12 and final assessment (Up to Week 12)
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 (Up to Week 12)
measure: Change From Baseline in Vaginal pH to Week 12
timeFrame: Baseline to Week 12
measure: Change From Baseline in the Percentage of Vaginal Superficial Cells to Week 12
timeFrame: Baseline to Week 12
measure: Change From Baseline in the Percentage of Vaginal Parabasal Cells to Week 12
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Birmingham
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: Chandler
country: United States
facility: Warner Chilcott Investigational Study Site
state: Arizona
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: Tucson
country: United States
facility: Warner Chilcott Investigational Study Site
state: Arizona
city: Sacramento
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: 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: Washington
country: United States
facility: Warner Chilcott Investigational Study Site
state: District of Columbia
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: 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: Lexington
country: United States
facility: Warner Chilcott Investigational Study Site
state: Kentucky
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: Chaska
country: United States
facility: Warner Chilcott Investigational Study Site
state: Minnesota
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: Raleigh
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: Cincinnati
country: United States
facility: Warner Chilcott Investigational Study Site
state: Ohio
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: Warwick
country: United States
facility: Warner Chilcott Investigational Study Site
state: Rhode Island
city: Bluffton
country: United States
facility: Warner Chilcott Investigational Study Site
state: South Carolina
city: Greer
country: United States
facility: Warner Chilcott Investigational Study Site
state: South Carolina
city: Austin
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: 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: South Jordan
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: