search
Back to results

Safety & Efficacy WC3011 (Estradiol Vaginal Cream) in the Treatment of Vulvovaginal Atrophy in Postmenopausal Women (VENUS)

Primary Purpose

Postmenopausal 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 Postmenopausal Vulvovaginal Atrophy focused on measuring Postmenopausal Women, Vaginal Dryness

Eligibility Criteria

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

Inclusion Criteria:

  • Postmenopausal females ≥35 years with either or both ovaries removed or naturally menopausal with moderate to severe vaginal dryness

Exclusion Criteria:

  • Hypersensitivity to estrogen and/or progestin therapy
  • Known or suspected premalignant or malignant disease (except successfully treated skin cancers)
  • Manifestation of or treatment for significant cardiovascular disease, congestive heart failure, stroke or ischemic attacks
  • Insulin-dependent diabetes mellitus
  • Increased frequency or severity of headaches while on hormone or estrogen therapy
  • Drug or alcohol addiction within last 2 years
  • Participation in a clinical trial within 30 days
  • Smoking ≥ 15 cigarettes daily
  • Uncontrolled hypertension - systolic blood pressure (BP) ≥ 160 mmHg or diastolic BP ≥ 95 mmHg

Sites / Locations

  • Medical Affiliated Research Center, Inc.
  • Mobile OB-GYN, PC
  • Women's Health Research
  • Precision Trials, LLC
  • Radiant Research-Scottsdale
  • Radiant Research-Tucson
  • Visions Clinical Research-tucson
  • Genesis Center for Clinical Research
  • Medical Center for Clinical Research
  • Women's Healthcare Inc.
  • Physicians' Research Options LLC
  • Costal Connecticut Resarch, LLC
  • Visions Clinical Research
  • Women's Medical Research Group, LLC
  • Jacksonville Center for Clinical Research
  • Miami Research Associates
  • New Age Medical Research Corp
  • Ormond Medical Arts Pharmaceutical Research Center
  • OB-GYN Specialists of the Palm
  • Radiant Research-St. Petersburg
  • Comprehensive Clinical Trials, LLC
  • Radiant Research-Atlanta
  • Soapstone Center for Clinical Research
  • Atlanta North Gynecology, PC
  • Fellows Research Alliance, Inc.
  • Radiant Research-Chicago
  • Springfield Clinical, LLP
  • The South Bend Clinic, LLP
  • Radiant Research - Overland Park
  • Heartland Research Associates
  • Kentucky Pediatric Research, Inc.
  • Bluegrass Clinical Research, Inc.
  • York Clinical Consulting
  • Women Under Study
  • Beyer Research
  • Ridgeview Research Two Twelve Medical Center
  • Affiliated Clinical Research
  • Lawrence OB-GYN Associates, P.C.
  • Phoenix OB-GYN Assoc., LLC
  • The Center for Women's Health and Wellness, LLC
  • Hawthorne Medical Research, Inc.
  • Eastern Carolina Women's Center
  • Wake Research Associates, LLC
  • Hawthorne Medical Research, Inc.
  • Lyndhurst Clinical Research
  • Rapid Medical Research, Inc.
  • The Columbus Center for Women's Health Research
  • HWC - Women's Research Center
  • Clinical Trials of America, Inc.
  • Advanced Clinical Research
  • The Clinical Trial Center, LLC
  • Philadelphia Clinical Research, LLC
  • Clinical Trials Research Services, LLC
  • Susan L. Floyd, MD, PC
  • Omega Medical Research
  • Fellows Research Alliance, Inc.
  • SC Clinical Research Center, LLC
  • Practice Research Organization, Inc.
  • Radiant Research-Dallas
  • Research Across America RHD Professional Plaza 4
  • Advances in Health, Inc.
  • Radiant Research-San Antonio
  • Center for Reproductive Medicine
  • J. Lewis Research-foothill Family Clinic
  • J. Lewis Research - Foothill Family Clinic South
  • Physicians' Research Options LLC
  • Eastern Virginia Medical School
  • Virginia Women's Center
  • Seattle Women's: Health, Research Gynecology
  • North Spokane Women's Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

WC3011 Estradiol Vaginal Cream (2 Times/Week)

Vehicle (2 Times/Week)

WC3011 Estradiol Vaginal Cream (3 Times/Week)

Vehicle (3 Times/Week)

Arm Description

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

Vehicle applied 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 3 times a week for 10 weeks.

Vehicle applied daily for 2 weeks, followed by dosing 3 times a week for 10 weeks.

Outcomes

Primary Outcome Measures

Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Week 12/Final Visit
The severity of vaginal dryness was assessed and recorded on a questionnaire by the participants using the following 4 point scale where, 0=None (The symptom is not present), 1=Mild (The symptom is present but may be intermittent; does not interfere with participants activities or lifestyle), 2=Moderate (The symptom is present. Participant is usually aware of the symptom, but activities and lifestyle are only occasionally affected), and 3=Severe (The symptom is present. Participant is usually aware and bothered by the symptom and have modified participant's activities and/or lifestyle due to the symptom. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Change From Baseline in Vaginal pH to Week 12/Final Visit
Vaginal pH was obtained at final visit of the study. The pH was a numeric value from a scale of 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. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12/Final Visit
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. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12/Final Visit
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. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.

Secondary Outcome Measures

Change From Baseline in Investigator's Assessment of Atrophy to Week 12 and Week 12/Final Visit
Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to atrophy scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Change From Baseline in Investigator's Assessment of Pallor to Week 12 and Week 12/Final Visit
Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to pallor scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Change From Baseline in Investigator's Assessment of Vaginal Dryness to Week 12 and Week 12/Final Visit
Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to vaginal dryness scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Change From Baseline in Investigator's Assessment of Friability to Week 12 and Week 12/Final Visit
Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to friability scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Change From Baseline in Investigator's Assessment of Petechiae to Week 12 and Week 12/Final Visit
Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to petechiae scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
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 symptoms of VVA (severity of vaginal dryness) was scored according to a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement.
Change From Baseline in Participant's Self-Assessment of Vaginal and/or Vulvar Irritation/Itching to Weeks 2, 4, 8, 12 and Week 12/Final Visit
Participant's self-assessment of symptoms of VVA (vaginal and/or vulvar irritation/itching) was scored according to a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Change From Baseline in Participant's Self-Assessment of Dysuria (Painful or Difficult Urination) to Weeks 2, 4, 8, 12 and Week 12/Final Visit
Participant's self-assessment of symptoms of VVA (dysuria) was scored according to a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Change From Baseline in Participant's Self-Assessment of Dyspareunia (Pain Associated With Sexual Activity) to Weeks 2, 4, 8, 12 and Week 12/Final Visit
Participant's self-assessment of symptoms of VVA (dyspareunia) was scored according to a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity as Per Participant's Self-Assessment to Weeks 2, 4, 8, 12 and Week 12/Final Visit
Vaginal bleeding associated with sexual activity was assessed by participants as either "present" or "absent". Percentage of participants with assessment "present" are reported. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Change From Baseline in Vaginal pH to Week 12
Vaginal pH was obtained at final visit of the study. The pH was a numeric value from a scale of 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 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.
Change From Baseline in 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.

Full Information

First Posted
July 20, 2011
Last Updated
April 11, 2022
Sponsor
Warner Chilcott
search

1. Study Identification

Unique Protocol Identification Number
NCT01400776
Brief Title
Safety & Efficacy WC3011 (Estradiol Vaginal Cream) in the Treatment of Vulvovaginal Atrophy in Postmenopausal Women
Acronym
VENUS
Official Title
A Randomized, Double-Blind, Vehicle-Controlled Study of the Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in the Treatment of Symptoms of Vulvovaginal Atrophy in Postmenopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
June 29, 2011 (Actual)
Primary Completion Date
February 27, 2012 (Actual)
Study Completion Date
February 27, 2012 (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
Study if WC3011 is effective and safe in the treatment of postmenopausal vaginal dryness due to vulvovaginal atrophy.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
WC3011 Estradiol Vaginal Cream (2 Times/Week)
Arm Type
Experimental
Arm Description
WC3011 estradiol vaginal cream applied daily for 2 weeks, followed by dosing 2 times a week for 10 weeks.
Arm Title
Vehicle (2 Times/Week)
Arm Type
Placebo Comparator
Arm Description
Vehicle applied daily for 2 weeks, followed by dosing 2 times a 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 2 weeks, followed by dosing 3 times a week for 10 weeks.
Arm Title
Vehicle (3 Times/Week)
Arm Type
Placebo Comparator
Arm Description
Vehicle applied daily for 2 weeks, followed by dosing 3 times a week for 10 weeks.
Intervention Type
Drug
Intervention Name(s)
WC3011 Estradiol Vaginal Cream
Intervention Description
WC3011 estradiol vaginal cream administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Vehicle administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks.
Primary Outcome Measure Information:
Title
Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Week 12/Final Visit
Description
The severity of vaginal dryness was assessed and recorded on a questionnaire by the participants using the following 4 point scale where, 0=None (The symptom is not present), 1=Mild (The symptom is present but may be intermittent; does not interfere with participants activities or lifestyle), 2=Moderate (The symptom is present. Participant is usually aware of the symptom, but activities and lifestyle are only occasionally affected), and 3=Severe (The symptom is present. Participant is usually aware and bothered by the symptom and have modified participant's activities and/or lifestyle due to the symptom. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Time Frame
Baseline (Day 0) to Week 12/Final Visit
Title
Change From Baseline in Vaginal pH to Week 12/Final Visit
Description
Vaginal pH was obtained at final visit of the study. The pH was a numeric value from a scale of 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. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Time Frame
Baseline (Day 0) to Week 12/Final Visit
Title
Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12/Final Visit
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. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Time Frame
Baseline (Day 0) to Week 12/Final Visit
Title
Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12/Final Visit
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. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Time Frame
Baseline (Day 0) to Week 12/Final Visit
Secondary Outcome Measure Information:
Title
Change From Baseline in Investigator's Assessment of Atrophy to Week 12 and Week 12/Final Visit
Description
Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to atrophy scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Time Frame
Baseline (Day 0) to Week 12 and Week 12/Final visit
Title
Change From Baseline in Investigator's Assessment of Pallor to Week 12 and Week 12/Final Visit
Description
Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to pallor scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Time Frame
Baseline (Day 0) to Week 12 and Week 12/Final visit
Title
Change From Baseline in Investigator's Assessment of Vaginal Dryness to Week 12 and Week 12/Final Visit
Description
Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to vaginal dryness scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Time Frame
Baseline (Day 0) to Week 12 and Week 12/Final visit
Title
Change From Baseline in Investigator's Assessment of Friability to Week 12 and Week 12/Final Visit
Description
Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to friability scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Time Frame
Baseline (Day 0) to Week 12 and Week 12/Final visit
Title
Change From Baseline in Investigator's Assessment of Petechiae to Week 12 and Week 12/Final Visit
Description
Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to petechiae scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Time Frame
Baseline (Day 0) to Week 12 and Week 12/Final visit
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 symptoms of VVA (severity of vaginal dryness) was scored according to a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement.
Time Frame
Baseline (Day 0) to Weeks 2, 4, 8 and 12
Title
Change From Baseline in Participant's Self-Assessment of Vaginal and/or Vulvar Irritation/Itching to Weeks 2, 4, 8, 12 and Week 12/Final Visit
Description
Participant's self-assessment of symptoms of VVA (vaginal and/or vulvar irritation/itching) was scored according to a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Time Frame
Baseline (Day 0) to Weeks 2, 4, 8, 12 and Week 12/Final visit
Title
Change From Baseline in Participant's Self-Assessment of Dysuria (Painful or Difficult Urination) to Weeks 2, 4, 8, 12 and Week 12/Final Visit
Description
Participant's self-assessment of symptoms of VVA (dysuria) was scored according to a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Time Frame
Baseline (Day 0) to Weeks 2, 4, 8, 12 and Week 12/Final visit
Title
Change From Baseline in Participant's Self-Assessment of Dyspareunia (Pain Associated With Sexual Activity) to Weeks 2, 4, 8, 12 and Week 12/Final Visit
Description
Participant's self-assessment of symptoms of VVA (dyspareunia) was scored according to a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Time Frame
Baseline (Day 0) to Weeks 2, 4, 8, 12 and Week 12/Final visit
Title
Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity as Per Participant's Self-Assessment to Weeks 2, 4, 8, 12 and Week 12/Final Visit
Description
Vaginal bleeding associated with sexual activity was assessed by participants as either "present" or "absent". Percentage of participants with assessment "present" are reported. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Time Frame
Baseline (Day 0) and Weeks 2, 4, 8, 12 and Week 12/Final visit
Title
Change From Baseline in Vaginal pH to Week 12
Description
Vaginal pH was obtained at final visit of the study. The pH was a numeric value from a scale of 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 (Day 0) to Week 12
Title
Change From Baseline in 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.
Time Frame
Baseline (Day 0) to Week 12
Title
Change From Baseline in 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.
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: Postmenopausal females ≥35 years with either or both ovaries removed or naturally menopausal with moderate to severe vaginal dryness Exclusion Criteria: Hypersensitivity to estrogen and/or progestin therapy Known or suspected premalignant or malignant disease (except successfully treated skin cancers) Manifestation of or treatment for significant cardiovascular disease, congestive heart failure, stroke or ischemic attacks Insulin-dependent diabetes mellitus Increased frequency or severity of headaches while on hormone or estrogen therapy Drug or alcohol addiction within last 2 years Participation in a clinical trial within 30 days Smoking ≥ 15 cigarettes daily Uncontrolled hypertension - systolic blood pressure (BP) ≥ 160 mmHg or diastolic BP ≥ 95 mmHg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Chan, PharmD
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Medical Affiliated Research Center, Inc.
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Mobile OB-GYN, PC
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Women's Health Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Facility Name
Precision Trials, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Radiant Research-Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Radiant Research-Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Visions Clinical Research-tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Genesis Center for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Medical Center for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Women's Healthcare Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Physicians' Research Options LLC
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Costal Connecticut Resarch, LLC
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
Facility Name
Visions Clinical Research
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Women's Medical Research Group, LLC
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33759
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Miami Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
New Age Medical Research Corp
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Ormond Medical Arts Pharmaceutical Research Center
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
OB-GYN Specialists of the Palm
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
Radiant Research-St. Petersburg
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Comprehensive Clinical Trials, LLC
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Radiant Research-Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Soapstone Center for Clinical Research
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30034
Country
United States
Facility Name
Atlanta North Gynecology, PC
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30075
Country
United States
Facility Name
Fellows Research Alliance, Inc.
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Radiant Research-Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60654
Country
United States
Facility Name
Springfield Clinical, LLP
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62703
Country
United States
Facility Name
The South Bend Clinic, LLP
City
Granger
State/Province
Indiana
ZIP/Postal Code
46530
Country
United States
Facility Name
Radiant Research - Overland Park
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66202
Country
United States
Facility Name
Heartland Research Associates
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Kentucky Pediatric Research, Inc.
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Facility Name
Bluegrass Clinical Research, Inc.
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40291
Country
United States
Facility Name
York Clinical Consulting
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Women Under Study
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Beyer Research
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Ridgeview Research Two Twelve Medical Center
City
Chaska
State/Province
Minnesota
ZIP/Postal Code
55318
Country
United States
Facility Name
Affiliated Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Lawrence OB-GYN Associates, P.C.
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Phoenix OB-GYN Assoc., LLC
City
Moorestown
State/Province
New Jersey
ZIP/Postal Code
08051
Country
United States
Facility Name
The Center for Women's Health and Wellness, LLC
City
Plainsboro
State/Province
New Jersey
ZIP/Postal Code
08536
Country
United States
Facility Name
Hawthorne Medical Research, Inc.
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Eastern Carolina Women's Center
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Hawthorne Medical Research, Inc.
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Lyndhurst Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Rapid Medical Research, Inc.
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
The Columbus Center for Women's Health Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
HWC - Women's Research Center
City
Englewood
State/Province
Ohio
ZIP/Postal Code
45322
Country
United States
Facility Name
Clinical Trials of America, Inc.
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Advanced Clinical Research
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
The Clinical Trial Center, LLC
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Philadelphia Clinical Research, LLC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Clinical Trials Research Services, LLC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
Facility Name
Susan L. Floyd, MD, PC
City
Wexford
State/Province
Pennsylvania
ZIP/Postal Code
15090
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Fellows Research Alliance, Inc.
City
Bluffton
State/Province
South Carolina
ZIP/Postal Code
29910
Country
United States
Facility Name
SC Clinical Research Center, LLC
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Practice Research Organization, Inc.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Radiant Research-Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Research Across America RHD Professional Plaza 4
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Advances in Health, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Radiant Research-San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Center for Reproductive Medicine
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
J. Lewis Research-foothill Family Clinic
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
J. Lewis Research - Foothill Family Clinic South
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
Physicians' Research Options LLC
City
Sandy
State/Province
Utah
ZIP/Postal Code
84070
Country
United States
Facility Name
Eastern Virginia Medical School
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507-1627
Country
United States
Facility Name
Virginia Women's Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23233
Country
United States
Facility Name
Seattle Women's: Health, Research Gynecology
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
North Spokane Women's Clinic
City
Spokane
State/Province
Washington
ZIP/Postal Code
99207
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Safety & Efficacy WC3011 (Estradiol Vaginal Cream) in the Treatment of Vulvovaginal Atrophy in Postmenopausal Women

We'll reach out to this number within 24 hrs