Postmenopausal Vulvovaginal AtrophyPhase 3VENUSNCT01400776
Safety & Efficacy WC3011 (Estradiol Vaginal Cream) in the Treatment of Vulvovaginal Atrophy in Postmenopausal Women
A Phase 3 study testing WC3011 Estradiol Vaginal Cream in people with Postmenopausal Vulvovaginal Atrophy, run by Warner Chilcott at 70 sites in United States.
Trial summary
Study if WC3011 is effective and safe in the treatment of postmenopausal vaginal dryness due to vulvovaginal atrophy. Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Postmenopausal Vulvovaginal Atrophy
- What is being tested?
- WC3011 Estradiol Vaginal Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 722 participants
- Where
- 70 sitesUnited States
- Study dates
- 29 Jun 2011to 27 Feb 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal females ≥35 years with either or both ovaries removed or naturally menopausal with moderate to severe vaginal dryness
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
70 sites in 1 country.
70 sites in 1 country
United States70 sites
Radiant Research-Atlanta
Atlanta, Georgia, 30342
Kentucky Pediatric Research, Inc.
Bardstown, Kentucky, 40004
Fellows Research Alliance, Inc.
Bluffton, South Carolina, 29910
Visions Clinical Research
Boynton Beach, Florida, 33472
Ridgeview Research Two Twelve Medical Center
Chaska, Minnesota, 55318
Radiant Research-Chicago
Chicago, Illinois, 60654
Women's Medical Research Group, LLC
Clearwater, Florida, 33759
Rapid Medical Research, Inc.
Cleveland, Ohio, 44122
SC Clinical Research Center, LLC
Columbia, South Carolina, 29201
The Columbus Center for Women's Health Research
Columbus, Ohio, 43213
Practice Research Organization, Inc.
Dallas, Texas, 75230
Radiant Research-Dallas
Dallas, Texas, 75231
Research Across America RHD Professional Plaza 4
Dallas, Texas, 75234
Soapstone Center for Clinical Research
Decatur, Georgia, 30034
HWC - Women's Research Center
Englewood, Ohio, 45322
Clinical Trials of America, Inc.
Eugene, Oregon, 97401
The South Bend Clinic, LLP
Granger, Indiana, 46530
Hawthorne Medical Research, Inc.
Greensboro, North Carolina, 27408
Advances in Health, Inc.
Houston, Texas, 77030
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, 35801
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, 19046
Beyer Research
Kalamazoo, Michigan, 49009
Physicians' Research Options LLC
Lakewood, Colorado, 80228
Affiliated Clinical Research
Las Vegas, Nevada, 89106
Lawrence OB-GYN Associates, P.C.
Lawrenceville, New Jersey, 08648
Bluegrass Clinical Research, Inc.
Louisville, Kentucky, 40291
York Clinical Consulting
Marrero, Louisiana, 70072
Advanced Clinical Research
Medford, Oregon, 97504
Miami Research Associates
Miami, Florida, 33143
New Age Medical Research Corp
Miami, Florida, 33186
Mobile OB-GYN, PC
Mobile, Alabama, 36608
Phoenix OB-GYN Assoc., LLC
Moorestown, New Jersey, 08051
Eastern Carolina Women's Center
New Bern, North Carolina, 28562
Costal Connecticut Resarch, LLC
New London, Connecticut, 06320
Women Under Study
New Orleans, Louisiana, 70115
Eastern Virginia Medical School
Norfolk, Virginia, 23507-1627
Ormond Medical Arts Pharmaceutical Research Center
Ormond Beach, Florida, 32174
Radiant Research - Overland Park
Overland Park, Kansas, 66202
OB-GYN Specialists of the Palm
Palm Beach Gardens, Florida, 33410
Philadelphia Clinical Research, LLC
Philadelphia, Pennsylvania, 19114
Women's Health Research
Phoenix, Arizona, 85015
Precision Trials, LLC
Phoenix, Arizona, 85032
Radiant Research-St. Petersburg
Pinellas Park, Florida, 33781
Clinical Trials Research Services, LLC
Pittsburgh, Pennsylvania, 15206
The Center for Women's Health and Wellness, LLC
Plainsboro, New Jersey, 08536
Wake Research Associates, LLC
Raleigh, North Carolina, 27612
Virginia Women's Center
Richmond, Virginia, 23233
Atlanta North Gynecology, PC
Roswell, Georgia, 30075
J. Lewis Research-foothill Family Clinic
Salt Lake City, Utah, 84109
J. Lewis Research - Foothill Family Clinic South
Salt Lake City, Utah, 84121
Radiant Research-San Antonio
San Antonio, Texas, 78229
Genesis Center for Clinical Research
San Diego, California, 92103
Medical Center for Clinical Research
San Diego, California, 92108
Women's Healthcare Inc.
San Diego, California, 92123
Physicians' Research Options LLC
Sandy City, Utah, 84070
Fellows Research Alliance, Inc.
Savannah, Georgia, 31406
Radiant Research-Scottsdale
Scottsdale, Arizona, 85251
Seattle Women's: Health, Research Gynecology
Seattle, Washington, 98105
North Spokane Women's Clinic
Spokane, Washington, 99207
Springfield Clinical, LLP
Springfield, Illinois, 62703
Radiant Research-Tucson
Tucson, Arizona, 85710
Visions Clinical Research-tucson
Tucson, Arizona, 85712
Omega Medical Research
Warwick, Rhode Island, 02886
Center for Reproductive Medicine
Webster, Texas, 77598
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, 33409
Susan L. Floyd, MD, PC
Wexford, Pennsylvania, 15090
Heartland Research Associates
Wichita, Kansas, 67207
Hawthorne Medical Research, Inc.
Winston-Salem, North Carolina, 27103
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103
About this study
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 if WC3011 is effective and safe in the treatment of postmenopausal vaginal dryness due to vulvovaginal atrophy.
- Conditions
- Postmenopausal Vulvovaginal Atrophy
- Being tested
- WC3011 Estradiol Vaginal Cream, Vehicle
- Keywords
- Postmenopausal Women, Vaginal Dryness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WC3011 Estradiol Vaginal CreamDrug
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
VehicleDrug
Vehicle administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Experimental | WC3011 estradiol vaginal cream applied daily for 2 weeks, followed by dosing 2 times a week for 10 weeks. Receives: Drug: WC3011 Estradiol Vaginal Cream |
| Vehicle (2 Times/Week) | Placebo comparator | Vehicle applied daily for 2 weeks, followed by dosing 2 times a week for 10 weeks. Receives: Drug: Vehicle |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Experimental | WC3011 estradiol vaginal cream applied daily for 2 weeks, followed by dosing 3 times a week for 10 weeks. Receives: Drug: WC3011 Estradiol Vaginal Cream |
| Vehicle (3 Times/Week) | Placebo comparator | Vehicle applied daily for 2 weeks, followed by dosing 3 times a week for 10 weeks. Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 0) to Week 12/Final Visit
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.
Measured: Baseline (Day 0) to Week 12/Final Visit
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.
Measured: Baseline (Day 0) to Week 12/Final Visit
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.
Measured: Baseline (Day 0) to Week 12/Final Visit
Secondary outcomes (13)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline (Day 0) and Weeks 2, 4, 8, 12 and Week 12/Final visit
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.
Measured: Baseline (Day 0) to Week 12
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.
Measured: Baseline (Day 0) to Week 12
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.
Measured: Baseline (Day 0) to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study start29 Jun 2011
- Primary completion27 Feb 2012
- Study completion27 Feb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postmenopausal Vulvovaginal AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 722 participants (actual)
Sponsor and investigators
- Lead sponsor
- Warner Chilcott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anna Chan, PharmD, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400776
- Sponsor's protocol ID
- PR-04409.3
- Acronym
- VENUS
- Status last verified
- Sep 2021
- First submitted
- 20 Jul 2011
- Last updated
- 9 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01400776
- Acronym / sponsor ID
- VENUS / PR-04409.3
- Conditions
- Postmenopausal Vulvovaginal Atrophy
- Keywords
- Postmenopausal Women, Vaginal Dryness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 722 participants (actual)
- Lead sponsor
- Warner ChilcottIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2011 (actual)
- Primary completion
- 27 Feb 2012 (actual)
- Study completion
- 27 Feb 2012 (actual)
- First posted
- 22 Jul 2011 (estimated)
- Results
- Posted 9 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study if WC3011 is effective and safe in the treatment of postmenopausal vaginal dryness due to vulvovaginal atrophy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Experimental | Drug: WC3011 Estradiol Vaginal CreamWC3011 estradiol vaginal cream applied daily for 2 weeks, followed by dosing 2 times a week for 10 weeks. |
| Vehicle (2 Times/Week) | Placebo comparator | Drug: VehicleVehicle applied daily for 2 weeks, followed by dosing 2 times a week for 10 weeks. |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Experimental | Drug: WC3011 Estradiol Vaginal CreamWC3011 estradiol vaginal cream applied daily for 2 weeks, followed by dosing 3 times a week for 10 weeks. |
| Vehicle (3 Times/Week) | Placebo comparator | Drug: VehicleVehicle applied daily for 2 weeks, followed by dosing 3 times a week for 10 weeks. |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Postmenopausal females ≥35 years with either or both ovaries removed or naturally menopausal with moderate to severe vaginal dryness
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WC3011 Estradiol Vaginal CreamWC3011 estradiol vaginal cream administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks | Drug | WC3011 Estradiol Vaginal Cream (2 Times/Week), WC3011 Estradiol Vaginal Cream (3 Times/Week) |
| VehicleVehicle administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks. | Drug | Vehicle (2 Times/Week), Vehicle (3 Times/Week) |
Primary outcome
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.
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.
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.
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.
13 secondary outcomes
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
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
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
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
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
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
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
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
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
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
Change From Baseline in Vaginal pH to Week 12
Time frame: 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
Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12
Time frame: Baseline (Day 0) to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Chan, PharmD study director
Allergan
70 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing WC3011 Estradiol Vaginal Cream in people with Postmenopausal Vulvovaginal Atrophy, run by Warner Chilcott at 70 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 70 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.