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

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 With Dyspareunia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01845649
• Other study ID #: PR-08112
• Status: Completed
• Phase: Phase 3
• Start date: April 12, 2013
• Est. completion date: November 20, 2013

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: November 20, 2013
• Est. primary completion date: November 20, 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Dyspareunia
• Vulvovaginal Atrophy

Intervention

Drug:
• WC3011 Estradiol Vaginal Cream
Daily for 14 days followed by 3 times per week for 10 weeks
• Vehicle
Daily for 14 days followed by 3 times per 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	Austin	Texas
United States	Warner Chilcott Investigational Study Site	Birmingham	Alabama
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	Chandler	Arizona
United States	Warner Chilcott Investigational Study Site	Chaska	Minnesota
United States	Warner Chilcott Investigational Study Site	Cincinnati	Ohio
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	Greer	South Carolina
United States	Warner Chilcott Investigational Study Site	Houston	Texas
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	Lexington	Kentucky
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	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	Raleigh	North Carolina
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	Sacramento	California
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	South Jordan	Utah
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	Tucson	Arizona
United States	Warner Chilcott Investigational Study Site	Warwick	Rhode Island
United States	Warner Chilcott Investigational Study Site	Washington	District of Columbia
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 Symptom of Vulvovaginal Atrophy (VVA): Dyspareunia (Pain Associated With Sexual Activity) to Final Assessment	Participant's self-assessment of the symptom of VVA (dyspareunia) was scored on a 4-point scale where: 0=none, 1=mild, 2=moderate or 3=severe. Higher score indicates 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 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 post-baseline assessment for the given efficacy endpoint.	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 the Symptom of VVA: Dyspareunia to Weeks 2, 4, 8, and 12	Participant's self-assessment of the symptom of VVA (dyspareunia) was scored on a 4-point scale where: 0=none, 1=mild, 2=moderate or 3=severe. Higher score indicates the most bothersome symptoms. A negative change from Baseline indicates improvement.	Baseline to Weeks 2, 4, 8 and 12
Secondary	Change From Baseline in Participant's Self-Assessment of the Other Symptoms of VVA to Weeks 2, 4, 8, 12, and Final Assessment	Self-Assessment of the symptoms of VVA, other than dyspareunia and vaginal bleeding associated with sexual activity, (vaginal and/or vulvar irritation/itching, dysuria and vaginal dryness) 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 (Up to Week 12)
Secondary	Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity at Each Visit	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 post-baseline assessment for the given efficacy endpoint.	Baseline (Day 0), Weeks 2, 4, 8, 12 and final assessment (Up to Week 12)
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 (Up to Week 12)
Secondary	Change From Baseline in Vaginal pH to Week 12	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.	Baseline to Week 12
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 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 to Week 12