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

April 11, 2022 updated by: Warner Chilcott

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 if WC3011 is effective and safe in the treatment of postmenopausal vaginal dryness due to vulvovaginal atrophy.

Study Overview

Study Type

Interventional

Enrollment (Actual)

722

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Medical Affiliated Research Center, Inc.
      • Mobile, Alabama, United States, 36608
        • Mobile Ob-Gyn, PC
    • Arizona
      • Phoenix, Arizona, United States, 85015
        • Women's Health Research
      • Phoenix, Arizona, United States, 85032
        • Precision Trials, LLC
      • Scottsdale, Arizona, United States, 85251
        • Radiant Research-Scottsdale
      • Tucson, Arizona, United States, 85712
        • Visions Clinical Research-Tucson
      • Tucson, Arizona, United States, 85710
        • Radiant Research-Tucson
    • California
      • San Diego, California, United States, 92108
        • Medical Center for Clinical Research
      • San Diego, California, United States, 92103
        • Genesis Center for Clinical Research
      • San Diego, California, United States, 92123
        • Women's Healthcare Inc.
    • Colorado
      • Lakewood, Colorado, United States, 80228
        • Physicians' Research Options LLC
    • Connecticut
      • New London, Connecticut, United States, 06320
        • Costal Connecticut Resarch, LLC
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Visions Clinical Research
      • Clearwater, Florida, United States, 33759
        • Women's Medical Research Group, LLC
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
      • Miami, Florida, United States, 33143
        • Miami Research Associates
      • Miami, Florida, United States, 33186
        • New Age Medical Research Corp
      • Ormond Beach, Florida, United States, 32174
        • Ormond Medical Arts Pharmaceutical Research Center
      • Palm Beach Gardens, Florida, United States, 33410
        • OB-GYN Specialists of the Palm
      • Pinellas Park, Florida, United States, 33781
        • Radiant Research-St. Petersburg
      • West Palm Beach, Florida, United States, 33409
        • Comprehensive Clinical Trials, Llc
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Radiant Research-Atlanta
      • Decatur, Georgia, United States, 30034
        • Soapstone Center for Clinical Research
      • Roswell, Georgia, United States, 30075
        • Atlanta North Gynecology, PC
      • Savannah, Georgia, United States, 31406
        • Fellows Research Alliance, Inc.
    • Illinois
      • Chicago, Illinois, United States, 60654
        • Radiant Research-Chicago
      • Springfield, Illinois, United States, 62703
        • Springfield Clinical, LLP
    • Indiana
      • Granger, Indiana, United States, 46530
        • The South Bend Clinic, LLP
    • Kansas
      • Overland Park, Kansas, United States, 66202
        • Radiant Research - Overland Park
      • Wichita, Kansas, United States, 67207
        • Heartland Research Associates
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
        • Kentucky Pediatric Research, Inc.
      • Louisville, Kentucky, United States, 40291
        • Bluegrass Clinical Research, Inc.
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • York Clinical Consulting
      • New Orleans, Louisiana, United States, 70115
        • Women Under Study
    • Michigan
      • Kalamazoo, Michigan, United States, 49009
        • Beyer Research
    • Minnesota
      • Chaska, Minnesota, United States, 55318
        • Ridgeview Research Two Twelve Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Affiliated Clinical Research
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Lawrence OB-GYN Associates, P.C.
      • Moorestown, New Jersey, United States, 08051
        • Phoenix OB-GYN Assoc., LLC
      • Plainsboro, New Jersey, United States, 08536
        • The Center for Women's Health and Wellness, LLC
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
        • Hawthorne Medical Research, Inc.
      • New Bern, North Carolina, United States, 28562
        • Eastern Carolina Women's Center
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates, LLC
      • Winston-Salem, North Carolina, United States, 27103
        • Lyndhurst Clinical Research
      • Winston-Salem, North Carolina, United States, 27103
        • Hawthorne Medical Research, Inc.
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • Rapid Medical Research, Inc.
      • Columbus, Ohio, United States, 43213
        • The Columbus Center for Women's Health Research
      • Englewood, Ohio, United States, 45322
        • HWC - Women's Research Center
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Clinical Trials of America, Inc.
      • Medford, Oregon, United States, 97504
        • Advanced Clinical Research
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 19046
        • The Clinical Trial Center, LLC
      • Philadelphia, Pennsylvania, United States, 19114
        • Philadelphia Clinical Research, LLC
      • Pittsburgh, Pennsylvania, United States, 15206
        • Clinical Trials Research Services, LLC
      • Wexford, Pennsylvania, United States, 15090
        • Susan L. Floyd, MD, PC
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Omega Medical Research
    • South Carolina
      • Bluffton, South Carolina, United States, 29910
        • Fellows Research Alliance, Inc.
      • Columbia, South Carolina, United States, 29201
        • SC Clinical Research Center, LLC
    • Texas
      • Dallas, Texas, United States, 75230
        • Practice Research Organization, Inc.
      • Dallas, Texas, United States, 75231
        • Radiant Research-Dallas
      • Dallas, Texas, United States, 75234
        • Research Across America RHD Professional Plaza 4
      • Houston, Texas, United States, 77030
        • Advances in Health, Inc.
      • San Antonio, Texas, United States, 78229
        • Radiant Research-San Antonio
      • Webster, Texas, United States, 77598
        • Center for Reproductive Medicine
    • Utah
      • Salt Lake City, Utah, United States, 84109
        • J. Lewis Research-Foothill Family Clinic
      • Salt Lake City, Utah, United States, 84121
        • J. Lewis Research - Foothill Family Clinic South
      • Sandy, Utah, United States, 84070
        • Physicians' Research Options LLC
    • Virginia
      • Norfolk, Virginia, United States, 23507-1627
        • Eastern Virginia Medical School
      • Richmond, Virginia, United States, 23233
        • Virginia Women's Center
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Women's: Health, Research Gynecology
      • Spokane, Washington, United States, 99207
        • North Spokane Women's Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: WC3011 Estradiol Vaginal Cream (2 Times/Week)
WC3011 estradiol vaginal cream applied daily for 2 weeks, followed by dosing 2 times a week for 10 weeks.
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
Placebo Comparator: Vehicle (2 Times/Week)
Vehicle applied daily for 2 weeks, followed by dosing 2 times a week for 10 weeks.
Vehicle administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks.
Experimental: WC3011 Estradiol Vaginal Cream (3 Times/Week)
WC3011 estradiol vaginal cream applied daily for 2 weeks, followed by dosing 3 times a week for 10 weeks.
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
Placebo Comparator: Vehicle (3 Times/Week)
Vehicle applied daily for 2 weeks, followed by dosing 3 times a week for 10 weeks.
Vehicle administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Week 12/Final Visit
Time Frame: Baseline (Day 0) 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.
Baseline (Day 0) to Week 12/Final Visit
Change From Baseline in Vaginal pH to Week 12/Final Visit
Time Frame: Baseline (Day 0) 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.
Baseline (Day 0) to Week 12/Final Visit
Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12/Final Visit
Time Frame: Baseline (Day 0) 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.
Baseline (Day 0) to Week 12/Final Visit
Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12/Final Visit
Time Frame: Baseline (Day 0) 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.
Baseline (Day 0) to Week 12/Final Visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Investigator's Assessment of Atrophy to Week 12 and Week 12/Final Visit
Time Frame: Baseline (Day 0) 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.
Baseline (Day 0) to Week 12 and Week 12/Final visit
Change From Baseline in Investigator's Assessment of Pallor to Week 12 and Week 12/Final Visit
Time Frame: Baseline (Day 0) 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.
Baseline (Day 0) to Week 12 and Week 12/Final visit
Change From Baseline in Investigator's Assessment of Vaginal Dryness to Week 12 and Week 12/Final Visit
Time Frame: Baseline (Day 0) 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.
Baseline (Day 0) to Week 12 and Week 12/Final visit
Change From Baseline in Investigator's Assessment of Friability to Week 12 and Week 12/Final Visit
Time Frame: Baseline (Day 0) 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.
Baseline (Day 0) to Week 12 and Week 12/Final visit
Change From Baseline in Investigator's Assessment of Petechiae to Week 12 and Week 12/Final Visit
Time Frame: Baseline (Day 0) 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.
Baseline (Day 0) to Week 12 and Week 12/Final visit
Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Weeks 2, 4, 8 and 12
Time Frame: Baseline (Day 0) 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.
Baseline (Day 0) to Weeks 2, 4, 8 and 12
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
Time Frame: Baseline (Day 0) 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.
Baseline (Day 0) to Weeks 2, 4, 8, 12 and Week 12/Final visit
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
Time Frame: Baseline (Day 0) 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.
Baseline (Day 0) to Weeks 2, 4, 8, 12 and Week 12/Final visit
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
Time Frame: Baseline (Day 0) 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.
Baseline (Day 0) to Weeks 2, 4, 8, 12 and Week 12/Final visit
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
Time Frame: Baseline (Day 0) and 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.
Baseline (Day 0) and Weeks 2, 4, 8, 12 and Week 12/Final visit
Change From Baseline in Vaginal pH to Week 12
Time Frame: Baseline (Day 0) 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.
Baseline (Day 0) to Week 12
Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12
Time Frame: Baseline (Day 0) 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.
Baseline (Day 0) to Week 12
Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12
Time Frame: Baseline (Day 0) 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.
Baseline (Day 0) to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 29, 2011

Primary Completion (Actual)

February 27, 2012

Study Completion (Actual)

February 27, 2012

Study Registration Dates

First Submitted

July 20, 2011

First Submitted That Met QC Criteria

July 20, 2011

First Posted (Estimate)

July 22, 2011

Study Record Updates

Last Update Posted (Actual)

May 9, 2022

Last Update Submitted That Met QC Criteria

April 11, 2022

Last Verified

September 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postmenopausal Vulvovaginal Atrophy

Clinical Trials on WC3011 Estradiol Vaginal Cream

3
Subscribe