Multicenter Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women

Vulvovaginal Atrophy Clinical Trial

Official title:

A Randomized, Multicenter, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of WC3011 in Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01816139
• Other study ID #: PR-05812
• Status: Completed
• Phase: Phase 3
• Start date: January 31, 2013
• Est. completion date: November 19, 2013

Study information

• Verified date: September 2021
• Source: Warner Chilcott
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 576
• Est. completion date: November 19, 2013
• Est. primary completion date: November 19, 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Vulvovaginal Atrophy

Intervention

Drug:
• Vehicle
Vehicle Cream applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks
• WC3011 Estradiol Vaginal Cream
WC3011 estradiol vaginal cream applied daily for 2 weeks followed by dosing 2 times a week for 10 weeks

Locations

Country	Name	City	State
United States	Warner Chilcott Investigational Study Site	Atlanta	Georgia
United States	Warner Chilcott Investigational Study Site	Bluffton	South Carolina
United States	Warner Chilcott Investigational Study Site	Boynton Beach	Florida
United States	Warner Chilcott Investigational Study Site	Clearwater	Florida
United States	Warner Chilcott Investigational Study Site	Cleveland	Ohio
United States	Warner Chilcott Investigational Study Site	Columbus	Ohio
United States	Warner Chilcott Investigational Study Site	Dallas	Texas
United States	Warner Chilcott Investigational Study Site	Dallas	Texas
United States	Warner Chilcott Investigational Study Site	Dallas	Texas
United States	Warner Chilcott Investigational Study Site	Granger	Indiana
United States	Warner Chilcott Investigational Study Site	Greensboro	North Carolina
United States	Warner Chilcott Investigational Study Site	Houston	Texas
United States	Warner Chilcott Investigational Study Site	Huntsville	Alabama
United States	Warner Chilcott Investigational Study Site	Jacksonville	Florida
United States	Warner Chilcott Investigational Study Site	Jenkintown	Pennsylvania
United States	Warner Chilcott Investigational Study Site	Kalamazoo	Michigan
United States	Warner Chilcott Investigational Study Site	Las Vegas	Nevada
United States	Warner Chilcott Investigational Study Site	Las Vegas	Nevada
United States	Warner Chilcott Investigational Study Site	Marrero	Louisiana
United States	Warner Chilcott Investigational Study Site	Miami	Florida
United States	Warner Chilcott Investigational Study Site	Miami	Florida
United States	Warner Chilcott Investigational Study Site	Mobile	Alabama
United States	Warner Chilcott Investigational Study Site	Moorestown	New Jersey
United States	Warner Chilcott Investigational Study Site	New Bern	North Carolina
United States	Warner Chilcott Investigational Study Site	New London	Connecticut
United States	Warner Chilcott Investigational Study Site	New Orleans	Louisiana
United States	Warner Chilcott Investigational Study Site	Norfolk	Virginia
United States	Warner Chilcott Investigational Study Site	Ormond Beach	Florida
United States	Warner Chilcott Investigational Study Site	Palm Beach Gardens	Florida
United States	Warner Chilcott Investigational Study Site	Philadelphia	Pennsylvania
United States	Warner Chilcott Investigational Study Site	Phoenix	Arizona
United States	Warner Chilcott Investigational Study Site	Pinellas Park	Florida
United States	Warner Chilcott Investigational Study Site	Pittsburgh	Pennsylvania
United States	Warner Chilcott Investigational Study Site	Richmond	Virginia
United States	Warner Chilcott Investigational Study Site	Roswell	Georgia
United States	Warner Chilcott Investigational Study Site	Salt Lake City	Utah
United States	Warner Chilcott Investigational Study Site	Salt Lake City	Utah
United States	Warner Chilcott Investigational Study Site	San Antonio	Texas
United States	Warner Chilcott Investigational Study Site	San Diego	California
United States	Warner Chilcott Investigational Study Site	San Diego	California
United States	Warner Chilcott Investigational Study Site	San Diego	California
United States	Warner Chilcott Investigational Study Site	Savannah	Georgia
United States	Warner Chilcott Investigational Study Site	Scottsdale	Arizona
United States	Warner Chilcott Investigational Study Site	Seattle	Washington
United States	Warner Chilcott Investigational Study Site	Spokane	Washington
United States	Warner Chilcott Investigational Study Site	Tucson	Arizona
United States	Warner Chilcott Investigational Study Site	West Palm Beach	Florida
United States	Warner Chilcott Investigational Study Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Warner Chilcott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Final Assessment	Participant's self-assessment of Vaginal Dryness was scored on a 4-point scale where: 0=none, 1=mild, 2=moderate or 3=severe. Higher scores indicate the most bothersome symptoms. A negative change from Baseline indicates improvement. Final assessment is defined as the last available postbaseline assessment.	Baseline (Day 0) to final assessment (Up to Week 12)
Primary	Change From Baseline in Vaginal pH to Final Assessment	Vaginal pH was obtained at baseline and final visit of the study. The pH was a numeric value from 0 to 14 expressing the acidity or alkalinity of the vaginal fluids where 7 was neutral, lower values were more acidic (values of 0-6) and higher values more alkaline (values of 8-14). A negative change from Baseline indicates improvement. Final assessment is defined as the last available postbaseline assessment.	Baseline (Day 0) to final assessment (Up to Week 12)
Primary	Change From Baseline in the Percentage of Vaginal Superficial Cells to Final Assessment	Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of superficial cells. A positive change from Baseline indicates improvement. Final assessment is defined as the last available postbaseline assessment.	Baseline (Day 0) to final assessment (Up to Week 12)
Primary	Change From Baseline in the Percentage of Vaginal Parabasal Cells to Final Assessment	Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of parabasal cells. A negative change from Baseline indicates improvement. Final assessment is defined as the last available postbaseline assessment.	Baseline (Day 0) to final assessment (Up to Week 12)
Secondary	Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Weeks 2, 4, 8, and 12	Participant's self-assessment of Vaginal Dryness was scored on a 4-point scale where: 0=none, 1=mild, 2=moderate or 3=severe. Higher scores indicate the most bothersome symptoms. A negative change from Baseline indicates improvement.	Baseline (Day 0) to Weeks 2, 4, 8, and 12
Secondary	Change From Baseline in Participants Self-Assessment of the Symptoms of VVA	Self-Assessment of the symptoms of VVA (vaginal and/or vulvar irritation/ Itching, dysuria, and dyspareunia) were evaluated by a questionnaire. Each symptom was scored on a 4-point scale where: 0=none, 1=mild, 2=moderate, or 3=severe. Higher scores indicate the most bothersome symptoms. A negative change from Baseline indicates improvement. Final Assessment is defined as the last available post-baseline assessment for the given efficacy endpoint.	Baseline (Day 0) to Weeks 2, 4, 8, 12 and Final Assessment
Secondary	Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity	Vaginal bleeding associated with sexual activity was assessed by participants as either "present" or "absent". Number of participants with assessment "present" are reported. Final assessment is defined as the last available postbaseline assessment.	Baseline (Day 0) and Weeks 2, 4, 8, 12 and Final Assessment
Secondary	Change From Baseline in the Investigator's Assessment of Each of the Signs of VVA to Week 12 and Final Assessment	Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to the signs of VVA: atrophy, pallor, vaginal dryness, friability, and petechiae each graded on a 4-point scale where: 0=none, 1=mild, 2=moderate or 3=severe. Higher scores are worse. A negative change from Baseline indicates improvement. Final assessment is defined as the last available postbaseline assessment.	Baseline (Day 0) to Week 12 and Final Assessment
Secondary	Change From Baseline in the Percentage of Vaginal Superficial Cells to Week 12	Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of superficial cells. A positive change from Baseline indicates improvement.	Baseline (Day 0) to Week 12
Secondary	Change From Baseline in the Percentage of Vaginal Parabasal Cells to Week 12	Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of parabasal cells. A negative change from Baseline indicates improvement.	Baseline (Day 0) to Week 12