search
Back to results

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

Primary Purpose

Vulvovaginal Atrophy

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Vehicle
WC3011 Estradiol Vaginal Cream
Sponsored by
Warner Chilcott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vulvovaginal Atrophy focused on measuring vaginal dryness, vaginal atrophy, estrogen

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vehicle (2 Times/Week)

WC3011 Estradiol Vaginal Cream (2 Times/Week)

Arm Description

Vehicle applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks.

WC3011 estradiol vaginal cream applied daily for 2 weeks followed by dosing 2 times a week for 10 weeks.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 13, 2013
Last Updated
April 11, 2022
Sponsor
Warner Chilcott
search

1. Study Identification

Unique Protocol Identification Number
NCT01816139
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 31, 2013 (Actual)
Primary Completion Date
November 19, 2013 (Actual)
Study Completion Date
November 19, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Warner Chilcott

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvovaginal Atrophy
Keywords
vaginal dryness, vaginal atrophy, estrogen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
576 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vehicle (2 Times/Week)
Arm Type
Experimental
Arm Description
Vehicle applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks.
Arm Title
WC3011 Estradiol Vaginal Cream (2 Times/Week)
Arm Type
Placebo Comparator
Arm Description
WC3011 estradiol vaginal cream applied daily for 2 weeks followed by dosing 2 times a week for 10 weeks.
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Vehicle Cream applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks
Intervention Type
Drug
Intervention Name(s)
WC3011 Estradiol Vaginal Cream
Intervention Description
WC3011 estradiol vaginal cream applied daily for 2 weeks followed by dosing 2 times a week for 10 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Final Assessment
Description
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.
Time Frame
Baseline (Day 0) to final assessment (Up to Week 12)
Title
Change From Baseline in Vaginal pH to Final Assessment
Description
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.
Time Frame
Baseline (Day 0) to final assessment (Up to Week 12)
Title
Change From Baseline in the Percentage of Vaginal Superficial Cells to Final Assessment
Description
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.
Time Frame
Baseline (Day 0) to final assessment (Up to Week 12)
Title
Change From Baseline in the Percentage of Vaginal Parabasal Cells to Final Assessment
Description
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.
Time Frame
Baseline (Day 0) to final assessment (Up to Week 12)
Secondary Outcome Measure Information:
Title
Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Weeks 2, 4, 8, and 12
Description
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.
Time Frame
Baseline (Day 0) to Weeks 2, 4, 8, and 12
Title
Change From Baseline in Participants Self-Assessment of the Symptoms of VVA
Description
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.
Time Frame
Baseline (Day 0) to Weeks 2, 4, 8, 12 and Final Assessment
Title
Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity
Description
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.
Time Frame
Baseline (Day 0) and Weeks 2, 4, 8, 12 and Final Assessment
Title
Change From Baseline in the Investigator's Assessment of Each of the Signs of VVA to Week 12 and Final Assessment
Description
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.
Time Frame
Baseline (Day 0) to Week 12 and Final Assessment
Title
Change From Baseline in the Percentage of Vaginal Superficial Cells to Week 12
Description
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.
Time Frame
Baseline (Day 0) to Week 12
Title
Change From Baseline in the Percentage of Vaginal Parabasal Cells to Week 12
Description
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.
Time Frame
Baseline (Day 0) to Week 12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Chan, PharmD
Organizational Affiliation
Warner Chilcott
Official's Role
Study Director
Facility Information:
Facility Name
Warner Chilcott Investigational Study Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33759
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30075
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Granger
State/Province
Indiana
ZIP/Postal Code
46530
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Moorestown
State/Province
New Jersey
ZIP/Postal Code
08057
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Bluffton
State/Province
South Carolina
ZIP/Postal Code
29910
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23233
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99207
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs