search
Back to results

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

Primary Purpose

Vulvovaginal Atrophy

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
WC3011 Estradiol Vaginal Cream
Vehicle
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 Vulvovaginal Atrophy, Dyspareunia, Postmenopausal

Eligibility Criteria

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

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

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
  • 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

Active Comparator

Experimental

Arm Label

Vehicle (3 Times/Week)

WC3011 Estradiol Vaginal Cream (3 Times/Week)

Arm Description

Vehicle applied to the vagina daily for 14 days followed by dosing 3 times per week for 10 weeks.

WC3011 Estradiol vaginal cream applied daily for 14 days followed by dosing 3 times per week for 10 weeks.

Outcomes

Primary Outcome Measures

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.
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.
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 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.
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.
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.
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 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.
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
April 25, 2013
Last Updated
April 11, 2022
Sponsor
Warner Chilcott
search

1. Study Identification

Unique Protocol Identification Number
NCT01845649
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 12, 2013 (Actual)
Primary Completion Date
November 20, 2013 (Actual)
Study Completion Date
November 20, 2013 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvovaginal Atrophy
Keywords
Vulvovaginal Atrophy, Dyspareunia, Postmenopausal

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Vehicle (3 Times/Week)
Arm Type
Active Comparator
Arm Description
Vehicle applied to the vagina daily for 14 days followed by dosing 3 times per week for 10 weeks.
Arm Title
WC3011 Estradiol Vaginal Cream (3 Times/Week)
Arm Type
Experimental
Arm Description
WC3011 Estradiol vaginal cream applied daily for 14 days followed by dosing 3 times per week for 10 weeks.
Intervention Type
Drug
Intervention Name(s)
WC3011 Estradiol Vaginal Cream
Other Intervention Name(s)
WC3011
Intervention Description
Daily for 14 days followed by 3 times per week for 10 weeks
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Daily for 14 days followed by 3 times per week for 10 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Participant's Self-Assessment of Symptom of Vulvovaginal Atrophy (VVA): Dyspareunia (Pain Associated With Sexual Activity) to Final Assessment
Description
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.
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 post-baseline assessment for the given efficacy endpoint.
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 the Symptom of VVA: Dyspareunia to Weeks 2, 4, 8, and 12
Description
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.
Time Frame
Baseline to Weeks 2, 4, 8 and 12
Title
Change From Baseline in Participant's Self-Assessment of the Other Symptoms of VVA to Weeks 2, 4, 8, 12, and Final Assessment
Description
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.
Time Frame
Baseline (Day 0) to Weeks 2, 4, 8, 12, and final assessment (Up to Week 12)
Title
Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity at Each Visit
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 post-baseline assessment for the given efficacy endpoint.
Time Frame
Baseline (Day 0), Weeks 2, 4, 8, 12 and final assessment (Up to Week 12)
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 (Up to Week 12)
Title
Change From Baseline in Vaginal pH to Week 12
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.
Time Frame
Baseline to Week 12
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 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 to Week 12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
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
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
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
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
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
85710
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
Sacramento
State/Province
California
ZIP/Postal Code
95821
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
Washington
State/Province
District of Columbia
ZIP/Postal Code
20036
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
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
30342
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
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
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
Chaska
State/Province
Minnesota
ZIP/Postal Code
55318
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
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
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
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
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
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
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
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
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
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
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
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507-1627
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

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

We'll reach out to this number within 24 hrs