Safety & Efficacy WC3011 (Estradiol Vaginal Cream) in the Treatment of Vulvovaginal Atrophy in Postmenopausal Women
- Conditions
- Postmenopausal Vulvovaginal Atrophy
- Interventions
- Drug: WC3011 Estradiol Vaginal CreamDrug: Vehicle
- Registration Number
- NCT01400776
- Lead Sponsor
- Warner Chilcott
- Brief Summary
Study if WC3011 is effective and safe in the treatment of postmenopausal vaginal dryness due to vulvovaginal atrophy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 722
- Postmenopausal females ≥35 years with either or both ovaries removed or naturally menopausal with moderate to severe vaginal dryness
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description WC3011 Estradiol Vaginal Cream (2 Times/Week) WC3011 Estradiol Vaginal Cream WC3011 estradiol vaginal cream applied daily for 2 weeks, followed by dosing 2 times a week for 10 weeks. Vehicle (2 Times/Week) Vehicle Vehicle applied daily for 2 weeks, followed by dosing 2 times a week for 10 weeks. WC3011 Estradiol Vaginal Cream (3 Times/Week) WC3011 Estradiol Vaginal Cream WC3011 estradiol vaginal cream applied daily for 2 weeks, followed by dosing 3 times a week for 10 weeks. Vehicle (3 Times/Week) Vehicle Vehicle applied daily for 2 weeks, followed by dosing 3 times a week for 10 weeks.
- Primary Outcome Measures
Name Time Method Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Week 12/Final Visit 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.
Change From Baseline in Vaginal pH to Week 12/Final Visit 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.
Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12/Final Visit 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.
Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12/Final Visit 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Investigator's Assessment of Vaginal Dryness to Week 12 and Week 12/Final Visit 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.
Change From Baseline in Investigator's Assessment of Atrophy to Week 12 and Week 12/Final Visit 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.
Change From Baseline in Investigator's Assessment of Pallor to Week 12 and Week 12/Final Visit 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.
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 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.
Change From Baseline in Investigator's Assessment of Friability to Week 12 and Week 12/Final Visit 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.
Change From Baseline in Investigator's Assessment of Petechiae to Week 12 and Week 12/Final Visit 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.
Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Weeks 2, 4, 8 and 12 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.
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 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.
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 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.
Change From Baseline in Vaginal pH to Week 12 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.
Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12 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.
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 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.
Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12 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.
Trial Locations
- Locations (67)
Radiant Research - Overland Park
🇺🇸Overland Park, Kansas, United States
Comprehensive Clinical Trials, LLC
🇺🇸West Palm Beach, Florida, United States
Soapstone Center for Clinical Research
🇺🇸Decatur, Georgia, United States
Women's Medical Research Group, LLC
🇺🇸Clearwater, Florida, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Ormond Medical Arts Pharmaceutical Research Center
🇺🇸Ormond Beach, Florida, United States
Visions Clinical Research-tucson
🇺🇸Tucson, Arizona, United States
Visions Clinical Research
🇺🇸Boynton Beach, Florida, United States
Fellows Research Alliance, Inc.
🇺🇸Bluffton, South Carolina, United States
Kentucky Pediatric Research, Inc.
🇺🇸Bardstown, Kentucky, United States
Radiant Research-Atlanta
🇺🇸Atlanta, Georgia, United States
Radiant Research-Chicago
🇺🇸Chicago, Illinois, United States
Rapid Medical Research, Inc.
🇺🇸Cleveland, Ohio, United States
Genesis Center for Clinical Research
🇺🇸San Diego, California, United States
Medical Center for Clinical Research
🇺🇸San Diego, California, United States
Miami Research Associates
🇺🇸Miami, Florida, United States
Women's Healthcare Inc.
🇺🇸San Diego, California, United States
Seattle Women's: Health, Research Gynecology
🇺🇸Seattle, Washington, United States
Heartland Research Associates
🇺🇸Wichita, Kansas, United States
Radiant Research-San Antonio
🇺🇸San Antonio, Texas, United States
J. Lewis Research - Foothill Family Clinic South
🇺🇸Salt Lake City, Utah, United States
Eastern Virginia Medical School
🇺🇸Norfolk, Virginia, United States
Precision Trials, LLC
🇺🇸Phoenix, Arizona, United States
Radiant Research-Tucson
🇺🇸Tucson, Arizona, United States
Mobile OB-GYN, PC
🇺🇸Mobile, Alabama, United States
Medical Affiliated Research Center, Inc.
🇺🇸Huntsville, Alabama, United States
Women's Health Research
🇺🇸Phoenix, Arizona, United States
Radiant Research-Scottsdale
🇺🇸Scottsdale, Arizona, United States
Physicians' Research Options LLC
🇺🇸Sandy, Utah, United States
Costal Connecticut Resarch, LLC
🇺🇸New London, Connecticut, United States
New Age Medical Research Corp
🇺🇸Miami, Florida, United States
OB-GYN Specialists of the Palm
🇺🇸Palm Beach Gardens, Florida, United States
Radiant Research-St. Petersburg
🇺🇸Pinellas Park, Florida, United States
Atlanta North Gynecology, PC
🇺🇸Roswell, Georgia, United States
The South Bend Clinic, LLP
🇺🇸Granger, Indiana, United States
Springfield Clinical, LLP
🇺🇸Springfield, Illinois, United States
York Clinical Consulting
🇺🇸Marrero, Louisiana, United States
Beyer Research
🇺🇸Kalamazoo, Michigan, United States
Women Under Study
🇺🇸New Orleans, Louisiana, United States
Ridgeview Research Two Twelve Medical Center
🇺🇸Chaska, Minnesota, United States
Affiliated Clinical Research
🇺🇸Las Vegas, Nevada, United States
Phoenix OB-GYN Assoc., LLC
🇺🇸Moorestown, New Jersey, United States
The Center for Women's Health and Wellness, LLC
🇺🇸Plainsboro, New Jersey, United States
Eastern Carolina Women's Center
🇺🇸New Bern, North Carolina, United States
Wake Research Associates, LLC
🇺🇸Raleigh, North Carolina, United States
The Columbus Center for Women's Health Research
🇺🇸Columbus, Ohio, United States
HWC - Women's Research Center
🇺🇸Englewood, Ohio, United States
Clinical Trials of America, Inc.
🇺🇸Eugene, Oregon, United States
Advanced Clinical Research
🇺🇸Medford, Oregon, United States
Philadelphia Clinical Research, LLC
🇺🇸Philadelphia, Pennsylvania, United States
Clinical Trials Research Services, LLC
🇺🇸Pittsburgh, Pennsylvania, United States
Susan L. Floyd, MD, PC
🇺🇸Wexford, Pennsylvania, United States
Omega Medical Research
🇺🇸Warwick, Rhode Island, United States
SC Clinical Research Center, LLC
🇺🇸Columbia, South Carolina, United States
Practice Research Organization, Inc.
🇺🇸Dallas, Texas, United States
Radiant Research-Dallas
🇺🇸Dallas, Texas, United States
Advances in Health, Inc.
🇺🇸Houston, Texas, United States
Research Across America RHD Professional Plaza 4
🇺🇸Dallas, Texas, United States
Center for Reproductive Medicine
🇺🇸Webster, Texas, United States
J. Lewis Research-foothill Family Clinic
🇺🇸Salt Lake City, Utah, United States
North Spokane Women's Clinic
🇺🇸Spokane, Washington, United States
Virginia Women's Center
🇺🇸Richmond, Virginia, United States
The Clinical Trial Center, LLC
🇺🇸Jenkintown, Pennsylvania, United States
Lyndhurst Clinical Research
🇺🇸Winston-Salem, North Carolina, United States
Bluegrass Clinical Research, Inc.
🇺🇸Louisville, Kentucky, United States
Hawthorne Medical Research, Inc.
🇺🇸Winston-Salem, North Carolina, United States
Lawrence OB-GYN Associates, P.C.
🇺🇸Lawrenceville, New Jersey, United States