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Vulvovaginal AtrophyPhase 3NCT01455597

Evaluate Long-Term Safety and Efficacy WC3011 (Estradiol Vaginal Cream)

A Phase 3 study testing WC3011 Estradiol Vaginal Cream in people with Vulvovaginal Atrophy, run by Warner Chilcott at 64 sites in United States.

Completed

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

Official record
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Trial summary

This is an open-label extension study evaluating the long-term safety and efficacy of WC3011 in non-hysterectomized, healthy, postmenopausal women with vulvovaginal atrophy. 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
309 participants
Where
64 sitesUnited States
Study dates
20 Oct 2011to 3 Dec 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

  • Completed Study PR-04409.3 (NCT01400776)

Who cannot join

  • Developed any of the following during Study-PR04409.3 or has begun taking hormone therapy other than WC3011:
  • 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, stroke or ischemic attack
  • Insulin-dependent diabetes mellitus
  • Smoking ≥ 15 cigarettes daily
  • Uncontrolled hypertension - systolic blood pressure (BP) ≥ 160 mmHG or diastolic ≥ 95 mmHg

Trial locations and contacts

64 sites in 1 country.

64 sites in 1 country

United States64 sites

  • Radiant Research-Atlanta

    Atlanta, Georgia, 30342

  • Fellows Research Alliance, Inc.

    Bluffton, South Carolina, 29910

  • Visions Clinical Research

    Boynton Beach, Florida, 33472

  • Ridgeview Research

    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

  • 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

    Dallas, Texas, 75234

  • 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

  • Beyer Research

    Kalamazoo, Michigan, 49009

  • Affiliated Clinical Research

    Las Vegas, Nevada, 89106

  • Office of R. Garn Mabey, M.D.

    Las Vegas, Nevada, 89128

  • 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

  • Warner Chilcott Investigational Site

    Mobile, Alabama, 36608

  • Phoenix OB-GYN Assoc., LLC

    Moorestown, New Jersey, 08057

  • Eastern Carolina Women's Center

    New Bern, North Carolina, 28562

  • Coastal Connecticut Research, 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 Beaches

    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

  • Women's Health Research Center

    Plainsboro, New Jersey, 08536

  • Wake Research Associates, LLC

    Raleigh, North Carolina, 27612

  • Virginia Women's Center

    Richmond, Virginia, 23233

  • 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

Other trials in United States

About this study

Official title: A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in the Treatment of Symptoms of Vulvovaginal Atrophy in Postmenopausal Women

This is an open-label extension study evaluating the long-term safety and efficacy of WC3011 in non-hysterectomized, healthy, postmenopausal women with vulvovaginal atrophy.

Being tested
WC3011 Estradiol Vaginal Cream
Keywords
Postmenopausal Women, Vaginal Dryness, Postmenopausal Vulvovaginal Atrophy

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, 3 times a week for 40 weeks.

Study groups in NCT01455597
Study groupRoleWhat they receive
WC3011 Estradiol Vaginal CreamExperimentalWC3011 estradiol vaginal cream 3 times a week for up to 40 weeks.
Receives: Drug: WC3011 Estradiol Vaginal Cream

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Endometrial Biopsy Results at Final Visit

    The endometrial biopsy results was categorized as: normal results categorized as atrophic/inactive or proliferative, unsatisfactory with endometrial thickness ≤4 mm and missing biopsy with endometrial thickness ≤4 mm; abnormal results categorized as polyp, hyperplasia, and carcinoma; unknown result categorized as unsatisfactory with endometrial thickness >4 mm, missing biopsy with endometrial thickness >4 mm, unsatisfactory without transvaginal ultrasonography (TVU) result and missing biopsy without TVU result. The duration of estradiol exposure was combination of studies PR-04409.3 and PR-04509.

    Measured: Final Visit (Day closest to Day 281)

Secondary outcomes (6)

  1. Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints

    Self-Assessment of the symptoms of VVA was evaluated for vaginal dryness, vaginal Itching, dysuria, and dyspareunia by a questionnaire. Questionnaire consisted of 5 questions scaled from 0 to 3 level of intensity, where 0-none indicated symptom not present; 1-mild indicated symptom is present but may be intermittent; does not interfere with your activities or lifestyle; 2-moderate indicated symptom is present, aware of the symptom but activities and lifestyle are only occasionally affected; 3-severe indicated usually aware and bothered by the symptom and have modified your activities and/or lifestyle due to the symptom. Higher score indicated most bothersome symptoms. A negative change from Baseline indicates improvement. Participants at Final visit/Visit 7 included those who were to complete all the evaluations in the study including who prematurely withdrew from the study.

    Measured: Baseline (Baseline/Visit 1 for this study was the same as Final Visit/Visit 5 for completers of PR-04409.3) to Weeks 4, 8, 16, 24, 32, 40 and Final Visit (Day closest to Day 281)

  2. Change From Baseline in Vaginal Cytology: Percentage of Superficial Vaginal Cells

    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. Participants at Final visit/Visit 7 included those who were to complete all the evaluations in the study including who prematurely withdrew from the study.

    Measured: Baseline (Baseline/Visit 1 for this study was the same as Final Visit/Visit 5 for completers of PR-04409.3) to Week 40 and Final Visit (Day closest to Day 281)

  3. Change From Baseline in Vaginal Cytology: Percentage of Parabasal Vaginal Cells

    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. Participants at Final visit/Visit 7 included those who were to complete all the evaluations in the study including who prematurely withdrew from the study.

    Measured: Baseline (Baseline/Visit 1 for this study was the same as Final Visit/Visit 5 for completers of PR-04409.3) to Week 40 and Final Visit (Day closest to Day 281)

  4. Change From Baseline in Vaginal pH

    Vaginal pH was obtained at 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. Participants at Final visit/Visit 7 included those who were to complete all the evaluations in the study including who prematurely withdrew from the study.

    Measured: Baseline (Baseline/Visit 1 for this study was the same as Final Visit/Visit 5 for completers of PR-04409.3) to Week 40 and Final Visit (Day closest to Day 281)

  5. Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA

    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 scored on a 4-point scale where: 0=none, 1=mild, 2=moderate, or 3= severe. The negative change from Baseline indicates improvement. Participants at Final visit/Visit 7 included those who were to complete all the evaluations in the study including who prematurely withdrew from the study.

    Measured: Baseline (Baseline/Visit 1 for this study was the same as Final Visit/Visit 5 for completers of PR-04409.3) to Week 40 and Final Visit (Day closest to Day 281)

  6. Number of Participants With At Least One Treatment Emergent Adverse Event (TEAE)

    An adverse event is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal (investigational) product, whether or not related to medicinal (investigational) product. TEAE are defined as those AEs with onset date on or after the first dose date of study drug in Study PR-04509, or adverse events that worsen after the first dose date of study drug in Study PR-04509.

    Measured: Up to Week 40

Timeline

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

  1. First posted20 Oct 2011 (estimated)
  2. Study start20 Oct 2011
  3. Primary completion3 Dec 2012
  4. Study completion3 Dec 2012

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
309 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01455597
Sponsor's protocol ID
PR-04509
Status last verified
Sep 2021
First submitted
17 Oct 2011
Last updated
9 May 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

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 64 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 7 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 64 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?

Number of Participants With Endometrial Biopsy Results at Final Visit (time frame: Final Visit (Day closest to Day 281)). 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 NCT01455597.

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.

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