Vulvovaginal AtrophyPhase 3NCT01845649

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

A Phase 3 study testing WC3011 Estradiol Vaginal Cream in people with Vulvovaginal Atrophy, run by Warner Chilcott at 57 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of the study is to determine if WC3011 is safe and effective in treating the symptom of painful intercourse secondary to vulvovaginal atrophy as measured by participant self-assessment when compared to vehicle. Read more about this study

Who is it for?: Ages 35 years and older, women only
Conditions the study is for: Vulvovaginal Atrophy
What is being tested?: WC3011 Estradiol Vaginal Cream
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 550 participants
Where: 57 sitesUnited States
Study dates: 12 Apr 2013to 20 Nov 2013
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

Sexually active with self-identified dyspareunia (pain with sexual activity), at least moderate to severe and most bothersome symptom of vulvovaginal atrophy (VVA)
Postmenopausal and meets 1 of the following: 12 months spontaneous amenorrhea, 6 months spontaneous amenorrhea with FSH (follicle stimulating hormone) >40 mIU/mL,6 weeks postsurgical bilateral oophorectomy with confirmation by FSH >40 mIU/mL, surgical report or ultrasound, 6 weeks postsurgical hysterectomy with ovary failure confirmed by FSH >40 mIU/mL
Age ≥40 years; ≥35 with bilateral oophorectomy
Vaginal pH >5.0
Less than or equal to 5% superficial cells on vaginal wall cytologic smear
Normal clinical breast exam or negative mammogram if ≥ 40 years of age
Negative urine pregnancy test (non-hysterectomized and <12 months amenorrhea)

Who cannot join

Enrollment in Sponsor's Study PR-04409 or PR-05812
Participation in clinical trial or use of investigational drug within 30 days prior to screening
Known hypersensitivity to estrogen and/or progestin therapy
Known or suspected premalignant or malignant disease or history steroid-dependent malignancy
Manifestation or treatment for significant cardiovascular disease (congestive heart failure, stroke or ischemic attack, myocardial infarction, coronary artery bypass, percutaneous angioplasty or >50% angiographic narrowing of coronary artery
Thrombophlebitis or thromboembolic disorder or history of

Show all 12Show fewer

Insulin-dependent diabetes mellitus
Increased frequency or severity of headaches while on hormone or estrogen therapy
Currently taking St. John's Wort
Drug/alcohol addiction within past 2 years
Treatment with anticoagulants (heparin or warfarin)
Smoking ≥15 cigarettes/day

Trial locations and contacts

57 sites in 1 country.

City, postcode or hospital

57 sites in 1 country

United States57 sites

Warner Chilcott Investigational Study Site
Atlanta, Georgia, 30342
Warner Chilcott Investigational Study Site
Austin, Texas, 78759
Warner Chilcott Investigational Study Site
Birmingham, Alabama, 35211
Warner Chilcott Investigational Study Site
Bluffton, South Carolina, 29910
Warner Chilcott Investigational Study Site
Boynton Beach, Florida, 33472
Warner Chilcott Investigational Study Site
Chandler, Arizona, 85224
Warner Chilcott Investigational Study Site
Chaska, Minnesota, 55318
Warner Chilcott Investigational Study Site
Cincinnati, Ohio, 45249
Warner Chilcott Investigational Study Site
Clearwater, Florida, 33759
Warner Chilcott Investigational Study Site
Cleveland, Ohio, 44122
Warner Chilcott Investigational Study Site
Columbus, Ohio, 43213
Warner Chilcott Investigational Study Site
Dallas, Texas, 75230
Warner Chilcott Investigational Study Site
Dallas, Texas, 75231
Warner Chilcott Investigational Study Site
Dallas, Texas, 75234
Warner Chilcott Investigational Study Site
Granger, Indiana, 46530
Warner Chilcott Investigational Study Site
Greensboro, North Carolina, 27408
Warner Chilcott Investigational Study Site
Greer, South Carolina, 29650
Warner Chilcott Investigational Study Site
Houston, Texas, 77030
Warner Chilcott Investigational Study Site
Jacksonville, Florida, 32216
Warner Chilcott Investigational Study Site
Jenkintown, Pennsylvania, 19046
Warner Chilcott Investigational Study Site
Kalamazoo, Michigan, 49009
Warner Chilcott Investigational Study Site
Las Vegas, Nevada, 89113
Warner Chilcott Investigational Study Site
Las Vegas, Nevada, 89128
Warner Chilcott Investigational Study Site
Lexington, Kentucky, 40509
Warner Chilcott Investigational Study Site
Marrero, Louisiana, 70072
Warner Chilcott Investigational Study Site
Miami, Florida, 33186
Warner Chilcott Investigational Study Site
Mobile, Alabama, 36608
Warner Chilcott Investigational Study Site
Moorestown, New Jersey, 08057
Warner Chilcott Investigational Study Site
New Bern, North Carolina, 28562
Warner Chilcott Investigational Study Site
New London, Connecticut, 06320
Warner Chilcott Investigational Study Site
New Orleans, Louisiana, 70115
Warner Chilcott Investigational Study Site
Norfolk, Virginia, 23507-1627
Warner Chilcott Investigational Study Site
Ormond Beach, Florida, 32174
Warner Chilcott Investigational Study Site
Palm Beach Gardens, Florida, 33410
Warner Chilcott Investigational Study Site
Philadelphia, Pennsylvania, 19114
Warner Chilcott Investigational Study Site
Phoenix, Arizona, 85032
Warner Chilcott Investigational Study Site
Pinellas Park, Florida, 33781
Warner Chilcott Investigational Study Site
Pittsburgh, Pennsylvania, 15206
Warner Chilcott Investigational Study Site
Raleigh, North Carolina, 27607
Warner Chilcott Investigational Study Site
Richmond, Virginia, 23233
Warner Chilcott Investigational Study Site
Roswell, Georgia, 30075
Warner Chilcott Investigational Study Site
Sacramento, California, 95821
Warner Chilcott Investigational Study Site
San Antonio, Texas, 78229
Warner Chilcott Investigational Study Site
San Diego, California, 92103
Warner Chilcott Investigational Study Site
San Diego, California, 92108
Warner Chilcott Investigational Study Site
San Diego, California, 92123
Warner Chilcott Investigational Study Site
Savannah, Georgia, 31406
Warner Chilcott Investigational Study Site
Scottsdale, Arizona, 85251
Warner Chilcott Investigational Study Site
Seattle, Washington, 98105
Warner Chilcott Investigational Study Site
South Jordan, Utah, 84095
Warner Chilcott Investigational Study Site
Spokane, Washington, 99207
Warner Chilcott Investigational Study Site
Tucson, Arizona, 85710
Warner Chilcott Investigational Study Site
Tucson, Arizona, 85712
Warner Chilcott Investigational Study Site
Warwick, Rhode Island, 02886
Warner Chilcott Investigational Study Site
Washington D.C., District of Columbia, 20036
Warner Chilcott Investigational Study Site
West Palm Beach, Florida, 33409
Warner Chilcott Investigational Study Site
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Randomized, Multicenter, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of WC3011 in Postmenopausal Women With Dyspareunia

Conditions: Vulvovaginal Atrophy
Being tested: WC3011 Estradiol Vaginal Cream, Vehicle
Keywords: Vulvovaginal Atrophy, Dyspareunia, Postmenopausal
Medical subject headings: Dyspareunia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

WC3011 Estradiol Vaginal CreamDrug
Also called WC3011
Daily for 14 days followed by 3 times per week for 10 weeks
VehicleDrug
Daily for 14 days followed by 3 times per week for 10 weeks

Study groups in NCT01845649
Study group	Role	What they receive
Vehicle (3 Times/Week)	Active comparator	Vehicle applied to the vagina daily for 14 days followed by dosing 3 times per week for 10 weeks. Receives: Drug: Vehicle
WC3011 Estradiol Vaginal Cream (3 Times/Week)	Experimental	WC3011 Estradiol vaginal cream applied daily for 14 days followed by dosing 3 times per week for 10 weeks. Receives: Drug: WC3011 Estradiol Vaginal Cream

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 Symptom of Vulvovaginal Atrophy (VVA): Dyspareunia (Pain Associated With Sexual Activity) to Final Assessment
Participant's self-assessment of the symptom of VVA (dyspareunia) was scored on a 4-point scale where: 0=none, 1=mild, 2=moderate or 3=severe. Higher score indicates the most bothersome symptoms. A negative change from Baseline indicates improvement. Final Assessment is defined as the last available post-baseline assessment for the given efficacy endpoint.
Measured: Baseline (Day 0) to final assessment (Up to Week 12)
Change From Baseline in Vaginal pH to Final Assessment
Vaginal pH was obtained at baseline and final visit of the study. The pH was a numeric value from 0 to 14 expressing the acidity or alkalinity of the vaginal fluids where 7 was neutral, lower values were more acidic (values of 0-6) and higher values more alkaline (values of 8-14). A negative change from Baseline indicates improvement. Final Assessment is defined as the last available post-baseline assessment for the given efficacy endpoint.
Measured: Baseline (Day 0) to final assessment (Up to Week 12)
Change From Baseline in the Percentage of Vaginal Superficial Cells to Final Assessment
Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of superficial cells. A positive change from Baseline indicates improvement. Final assessment is defined as the last available postbaseline assessment.
Measured: Baseline (Day 0) to final assessment (Up to Week 12)
Change From Baseline in the Percentage of Vaginal Parabasal Cells to Final Assessment
Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of parabasal cells. A negative change from Baseline indicates improvement. Final assessment is defined as the last available postbaseline assessment.
Measured: Baseline (Day 0) to final assessment (Up to Week 12)

Secondary outcomes (7)

Change From Baseline in Participant's Self-Assessment of the Symptom of VVA: Dyspareunia to Weeks 2, 4, 8, and 12
Participant's self-assessment of the symptom of VVA (dyspareunia) was scored on a 4-point scale where: 0=none, 1=mild, 2=moderate or 3=severe. Higher score indicates the most bothersome symptoms. A negative change from Baseline indicates improvement.
Measured: Baseline to Weeks 2, 4, 8 and 12
Change From Baseline in Participant's Self-Assessment of the Other Symptoms of VVA to Weeks 2, 4, 8, 12, and Final Assessment
Self-Assessment of the symptoms of VVA, other than dyspareunia and vaginal bleeding associated with sexual activity, (vaginal and/or vulvar irritation/itching, dysuria and vaginal dryness) were evaluated by a questionnaire. Each symptom was scored on a 4-point scale where: 0=none, 1=mild, 2=moderate or 3=severe. Higher scores indicate the most bothersome symptoms. A negative change from Baseline indicates improvement. Final Assessment is defined as the last available post-baseline assessment for the given efficacy endpoint.
Measured: Baseline (Day 0) to Weeks 2, 4, 8, 12, and final assessment (Up to Week 12)
Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity at Each Visit
Vaginal bleeding associated with sexual activity was assessed by participants as either "present" or "absent". Number of participants with assessment "present" are reported. Final Assessment is defined as the last available post-baseline assessment for the given efficacy endpoint.
Measured: Baseline (Day 0), Weeks 2, 4, 8, 12 and final assessment (Up to Week 12)
Change From Baseline in the Investigator's Assessment of Each of the Signs of VVA to Week 12 and Final Assessment
Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to the signs of VVA: atrophy, pallor, vaginal dryness, friability, and petechiae each graded on a 4-point scale where: 0=none, 1=mild, 2=moderate or 3=severe. Higher scores are worse. A negative change from Baseline indicates improvement. Final assessment is defined as the last available postbaseline assessment.
Measured: Baseline (Day 0) to Week 12 and Final assessment (Up to Week 12)
Change From Baseline in Vaginal pH to Week 12
Vaginal pH was obtained at baseline and final visit of the study. The pH was a numeric value from 0 to 14 expressing the acidity or alkalinity of the vaginal fluids where 7 was neutral, lower values were more acidic (values of 0-6) and higher values more alkaline (values of 8-14). A negative change from Baseline indicates improvement.
Measured: Baseline to Week 12
Change From Baseline in the Percentage of Vaginal Superficial Cells to Week 12
Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of superficial cells. A positive change from Baseline indicates improvement.
Measured: Baseline to Week 12
Change From Baseline in the Percentage of Vaginal Parabasal Cells to Week 12
Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of parabasal cells. A negative change from Baseline indicates improvement.
Measured: Baseline to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Apr 201320 Nov 2013

First posted3 May 2013 (estimated)
Study start12 Apr 2013
Primary completion20 Nov 2013
Study completion20 Nov 2013

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 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: 550 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01845649
Sponsor's protocol ID: PR-08112
Status last verified: Sep 2021
First submitted: 25 Apr 2013
Last updated: 9 May 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Proof of Concept Study of Vaginal AZU-101 in Vulvovaginal Atrophy in Postmenopausal Women
Vulvo Vaginal Atrophy (VVA)
Recruiting
F-GYN for Vaginal Dryness and Vulvovaginal Atrophy
Atrophic Vaginitis, Atrophic Vulvovaginitis
Recruiting
A Laser and Topical Treatment Combination in the Vulvo-vaginal Atrophy Management in Breast Cancer Patients.
Female Urogenital Diseases, Breast Cancer Female
Not yet recruitingObservational study
Retrospective Cohort Study of Symptoms and Quality of Life in Women With Genitourinary Syndrome of Menopause.
Vulvar Atrophy, Vulvovaginal Signs and Symptoms
RecruitingObservational study
Determining the Extent of the Genitourinary Syndrome of Menopause Burden in Breast Cancer Survivors
Genitourinary Syndrome of Menopause (GSM), Breast Cancer

All Vulvovaginal Atrophy trials

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, Multicenter, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of WC3011 in Postmenopausal Women With Dyspareunia
ClinicalTrials.gov ID: NCT01845649
Acronym / sponsor ID: PR-08112
Conditions: Vulvovaginal Atrophy
Keywords: Vulvovaginal Atrophy, Dyspareunia, Postmenopausal
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 550 participants (actual)
Lead sponsor: Warner ChilcottIndustry (pharma, biotech, devices)
Study start: 12 Apr 2013 (actual)
Primary completion: 20 Nov 2013 (actual)
Study completion: 20 Nov 2013 (actual)
First posted: 3 May 2013 (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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Vehicle (3 Times/Week)	Active comparator	Drug: VehicleVehicle applied to the vagina daily for 14 days followed by dosing 3 times per week for 10 weeks.
WC3011 Estradiol Vaginal Cream (3 Times/Week)	Experimental	Drug: WC3011 Estradiol Vaginal CreamWC3011 Estradiol vaginal cream applied daily for 14 days followed by dosing 3 times per 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 (7 listed)

Sexually active with self-identified dyspareunia (pain with sexual activity), at least moderate to severe and most bothersome symptom of vulvovaginal atrophy (VVA)
Postmenopausal and meets 1 of the following: 12 months spontaneous amenorrhea, 6 months spontaneous amenorrhea with FSH (follicle stimulating hormone) >40 mIU/mL,6 weeks postsurgical bilateral oophorectomy with confirmation by FSH >40 mIU/mL, surgical report or ultrasound, 6 weeks postsurgical hysterectomy with ovary failure confirmed by FSH >40 mIU/mL
Age ≥40 years; ≥35 with bilateral oophorectomy
Vaginal pH >5.0
Less than or equal to 5% superficial cells on vaginal wall cytologic smear

Key exclusion criteria (12 listed)

Enrollment in Sponsor's Study PR-04409 or PR-05812
Participation in clinical trial or use of investigational drug within 30 days prior to screening
Known hypersensitivity to estrogen and/or progestin therapy
Known or suspected premalignant or malignant disease or history steroid-dependent malignancy
Manifestation or treatment for significant cardiovascular disease (congestive heart failure, stroke or ischemic attack, myocardial infarction, coronary artery bypass, percutaneous angioplasty or >50% angiographic narrowing of coronary artery

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 CreamAlso: WC3011Daily for 14 days followed by 3 times per week for 10 weeks	Drug	WC3011 Estradiol Vaginal Cream (3 Times/Week)
VehicleDaily for 14 days followed by 3 times per week for 10 weeks	Drug	Vehicle (3 Times/Week)

Primary outcome

Change From Baseline in Participant's Self-Assessment of Symptom of Vulvovaginal Atrophy (VVA): Dyspareunia (Pain Associated With Sexual Activity) to Final Assessment
Time frame: Baseline (Day 0) to final assessment (Up to Week 12)
Participant's self-assessment of the symptom of VVA (dyspareunia) was scored on a 4-point scale where: 0=none, 1=mild, 2=moderate or 3=severe. Higher score indicates the most bothersome symptoms. A negative change from Baseline indicates improvement. Final Assessment is defined as the last available post-baseline assessment for the given efficacy endpoint.
Change From Baseline in Vaginal pH to Final Assessment
Time frame: Baseline (Day 0) to final assessment (Up to Week 12)
Vaginal pH was obtained at baseline and final visit of the study. The pH was a numeric value from 0 to 14 expressing the acidity or alkalinity of the vaginal fluids where 7 was neutral, lower values were more acidic (values of 0-6) and higher values more alkaline (values of 8-14). A negative change from Baseline indicates improvement. Final Assessment is defined as the last available post-baseline assessment for the given efficacy endpoint.
Change From Baseline in the Percentage of Vaginal Superficial Cells to Final Assessment
Time frame: Baseline (Day 0) to final assessment (Up to Week 12)
Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of superficial cells. A positive change from Baseline indicates improvement. Final assessment is defined as the last available postbaseline assessment.
Change From Baseline in the Percentage of Vaginal Parabasal Cells to Final Assessment
Time frame: Baseline (Day 0) to final assessment (Up to Week 12)
Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of parabasal cells. A negative change from Baseline indicates improvement. Final assessment is defined as the last available postbaseline assessment.

7 secondary outcomes

Change From Baseline in Participant's Self-Assessment of the Symptom of VVA: Dyspareunia to Weeks 2, 4, 8, and 12
Time frame: Baseline to Weeks 2, 4, 8 and 12
Change From Baseline in Participant's Self-Assessment of the Other Symptoms of VVA to Weeks 2, 4, 8, 12, and Final Assessment
Time frame: Baseline (Day 0) to Weeks 2, 4, 8, 12, and final assessment (Up to Week 12)
Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity at Each Visit
Time frame: Baseline (Day 0), Weeks 2, 4, 8, 12 and final assessment (Up to Week 12)
Change From Baseline in the Investigator's Assessment of Each of the Signs of VVA to Week 12 and Final Assessment
Time frame: Baseline (Day 0) to Week 12 and Final assessment (Up to Week 12)
Change From Baseline in Vaginal pH to Week 12
Time frame: Baseline to Week 12
Change From Baseline in the Percentage of Vaginal Superficial Cells to Week 12
Time frame: Baseline to Week 12
Change From Baseline in the Percentage of Vaginal Parabasal Cells to Week 12
Time frame: Baseline to Week 12

Results and safety

Results posted to the registry on 9 May 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vehicle (3 Times/Week)	273	242
WC3011 Estradiol Vaginal Cream (3 Times/Week)	277	255

Primary outcome: Change From Baseline in Participant's Self-Assessment of Symptom of Vulvovaginal Atrophy (VVA): Dyspareunia (Pain Associated With Sexual Activity) to Final Assessment

Time frame: Baseline (Day 0) to final assessment (Up to Week 12). Mean (Standard Deviation). Unit: score on a scale

Measure	Vehicle (3 Times/Week) n = 233	WC3011 Estradiol Vaginal Cream (3 Times/Week) n = 239
Baseline	2.7 (0.44)	2.7 (0.45)
Change from Baseline to Final Assessment	-1.2 (0.93)	-1.5 (0.97)

Population analysed: Modified Intent-to-treat (mITT) Population included participants in the Safety population who had at least 1 postbaseline primary efficacy assessment and met all of the following inclusion criteria: ≤5% superficial cells on a vaginal wall smear, a vaginal pH \>5.0, and the participants most bothersome symptom of VVA was dyspareunia with moderate to severe intensity. Number analyzed is the number of participants with available data at the given timepoint.

Primary outcome: Change From Baseline in Vaginal pH to Final Assessment

Time frame: Baseline (Day 0) to final assessment (Up to Week 12). Mean (Standard Deviation). Unit: score on a scale

Measure	Vehicle (3 Times/Week) n = 233	WC3011 Estradiol Vaginal Cream (3 Times/Week) n = 239
Baseline	6.35 (0.66)	6.37 (0.66)
Change from Baseline to Final Assessment	-0.53 (0.92)	-1.36 (0.89)

Population analysed: mITT Population included participants in the Safety population who had at least 1 postbaseline primary efficacy assessment and met all of the following inclusion criteria: ≤5% superficial cells on a vaginal wall smear, a vaginal pH \>5.0, and the participants most bothersome symptom of VVA was dyspareunia with moderate to severe intensity. Number analyzed is the number of participants with available data at the given timepoint.

Primary outcome: Change From Baseline in the Percentage of Vaginal Superficial Cells to Final Assessment

Time frame: Baseline (Day 0) to final assessment (Up to Week 12). Mean (Standard Deviation). Unit: percentage of superficial cells

Measure	Vehicle (3 Times/Week) n = 233	WC3011 Estradiol Vaginal Cream (3 Times/Week) n = 239
Baseline	0.2 (0.75)	0.2 (0.70)
Change from Baseline to Final Assessment	1.4 (6.08)	10.1 (16.72)

Primary outcome: Change From Baseline in the Percentage of Vaginal Parabasal Cells to Final Assessment

Time frame: Baseline (Day 0) to final assessment (Up to Week 12). Mean (Standard Deviation). Unit: percentage of parabasal cells

Measure	Vehicle (3 Times/Week) n = 233	WC3011 Estradiol Vaginal Cream (3 Times/Week) n = 239
Baseline	50.6 (43.09)	53.5 (42.00)
Change From Baseline to Final Assessment	-14.6 (39.55)	-48.5 (45.11)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Week 12. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vehicle (3 Times/Week)	1 of 271 (0.4%)	42 of 271 (15.5%)	0 of 271
WC3011 Estradiol Vaginal Cream (3 Times/Week)	3 of 277 (1.1%)	38 of 277 (13.7%)	0 of 277

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.

Related trials for Vulvovaginal Atrophy

RecruitingPhase 2
Proof of Concept Study of Vaginal AZU-101 in Vulvovaginal Atrophy in Postmenopausal Women
Vulvo Vaginal Atrophy (VVA)
Recruiting
F-GYN for Vaginal Dryness and Vulvovaginal Atrophy
Atrophic Vaginitis, Atrophic Vulvovaginitis
Recruiting
A Laser and Topical Treatment Combination in the Vulvo-vaginal Atrophy Management in Breast Cancer Patients.
Female Urogenital Diseases, Breast Cancer Female
Not yet recruitingObservational study
Retrospective Cohort Study of Symptoms and Quality of Life in Women With Genitourinary Syndrome of Menopause.
Vulvar Atrophy, Vulvovaginal Signs and Symptoms
RecruitingObservational study
Determining the Extent of the Genitourinary Syndrome of Menopause Burden in Breast Cancer Survivors
Genitourinary Syndrome of Menopause (GSM), Breast Cancer

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

Warner Chilcott

57 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 Vulvovaginal Atrophy, run by Warner Chilcott at 57 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 7 inclusion and 12 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 57 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. 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 Symptom of Vulvovaginal Atrophy (VVA): Dyspareunia (Pain Associated With Sexual Activity) to Final Assessment (time frame: Baseline (Day 0) to final assessment (Up to Week 12)). 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?

On the ClinicalTrials.gov record for NCT01845649.

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.