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

NCT01455597 | Completed Phase 3 Results FDA Drug

• 1 other identifier: PR-04509
• Study Type: interventional
• Target: 309
• Locations: 1 country
• Sites: 64

Brief 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.

Conditions

Vulvovaginal Atrophy

Keywords

Postmenopausal Women; Vaginal Dryness; Postmenopausal Vulvovaginal Atrophy

Outcome Measures

Primary Outcomes (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.

  Final Visit (Day closest to Day 281)

Secondary Outcomes (6)

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

  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)

• Change From Baseline in Vaginal Cytology: Percentage of Superficial Vaginal Cells

  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)

• Change From Baseline in Vaginal Cytology: Percentage of Parabasal Vaginal Cells

  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)

• Change From Baseline in Vaginal pH

  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)

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

  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)

Study Arms (1)

WC3011 Estradiol Vaginal Cream

EXPERIMENTAL

WC3011 estradiol vaginal cream 3 times a week for up to 40 weeks.

Drug: WC3011 Estradiol Vaginal Cream

Interventions

WC3011 Estradiol Vaginal Cream DRUG

WC3011 estradiol vaginal cream, 3 times a week for 40 weeks.

WC3011 Estradiol Vaginal Cream

Eligibility Criteria

• Age: 35 Years+
• Gender Eligibility Details: The study was to treat the symptoms of vulvovaginal atrophy in postmenopausal women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Completed Study PR-04409.3 (NCT01400776)

You may not qualify if:

• 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

Sponsors & Collaborators

• Warner Chilcott: lead

Study Sites (64)

Medical Affiliated Research Center, Inc.

Huntsville, Alabama, 35801, United States

Location

Warner Chilcott Investigational Site

Mobile, Alabama, 36608, United States

Location

Women's Health Research

Phoenix, Arizona, 85015, United States

Location

Precision Trials, LLC

Phoenix, Arizona, 85032, United States

Location

Radiant Research-Scottsdale

Scottsdale, Arizona, 85251, United States

Location

Radiant Research-Tucson

Tucson, Arizona, 85710, United States

Location

Visions Clinical Research-Tucson

Tucson, Arizona, 85712, United States

Location

Genesis Center for Clinical Research

San Diego, California, 92103, United States

Location

Medical Center for Clinical Research

San Diego, California, 92108, United States

Location

Women's Healthcare Inc.

San Diego, California, 92123, United States

Location

Coastal Connecticut Research, LLC

New London, Connecticut, 06320, United States

Location

Visions Clinical Research

Boynton Beach, Florida, 33472, United States

Location

Women's Medical Research Group, LLC

Clearwater, Florida, 33759, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Miami Research Associates

Miami, Florida, 33143, United States

Location

New Age Medical Research Corp

Miami, Florida, 33186, United States

Location

Ormond Medical Arts Pharmaceutical Research Center

Ormond Beach, Florida, 32174, United States

Location

OB-GYN Specialists of the Palm Beaches

Palm Beach Gardens, Florida, 33410, United States

Location

Radiant Research-St. Petersburg

Pinellas Park, Florida, 33781, United States

Location

Comprehensive Clinical Trials, LLC

West Palm Beach, Florida, 33409, United States

Location

Radiant Research-Atlanta

Atlanta, Georgia, 30342, United States

Location

Fellows Research Alliance, Inc.

Savannah, Georgia, 31406, United States

Location

Radiant Research-Chicago

Chicago, Illinois, 60654, United States

Location

Springfield Clinical, LLP

Springfield, Illinois, 62703, United States

Location

The South Bend Clinic, LLP

Granger, Indiana, 46530, United States

Location

Radiant Research - Overland Park

Overland Park, Kansas, 66202, United States

Location

Heartland Research Associates

Wichita, Kansas, 67207, United States

Location

Bluegrass Clinical Research, Inc.

Louisville, Kentucky, 40291, United States

Location

York Clinical Consulting

Marrero, Louisiana, 70072, United States

Location

Women Under Study

New Orleans, Louisiana, 70115, United States

Location

Beyer Research

Kalamazoo, Michigan, 49009, United States

Location

Ridgeview Research

Chaska, Minnesota, 55318, United States

Location

Affiliated Clinical Research

Las Vegas, Nevada, 89106, United States

Location

Office of R. Garn Mabey, M.D.

Las Vegas, Nevada, 89128, United States

Location

Lawrence OB-GYN Associates, P.C.

Lawrenceville, New Jersey, 08648, United States

Location

Phoenix OB-GYN Assoc., LLC

Moorestown, New Jersey, 08057, United States

Location

Women's Health Research Center

Plainsboro, New Jersey, 08536, United States

Location

Hawthorne Medical Research, Inc.

Greensboro, North Carolina, 27408, United States

Location

Eastern Carolina Women's Center

New Bern, North Carolina, 28562, United States

Location

Wake Research Associates, LLC

Raleigh, North Carolina, 27612, United States

Location

Hawthorne Medical Research, Inc.

Winston-Salem, North Carolina, 27103, United States

Location

Lyndhurst Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Rapid Medical Research, Inc.

Cleveland, Ohio, 44122, United States

Location

The Columbus Center for Women's Health Research

Columbus, Ohio, 43213, United States

Location

Clinical Trials of America, Inc.

Eugene, Oregon, 97401, United States

Location

Advanced Clinical Research

Medford, Oregon, 97504, United States

Location

Philadelphia Clinical Research, LLC

Philadelphia, Pennsylvania, 19114, United States

Location

Clinical Trials Research Services, LLC

Pittsburgh, Pennsylvania, 15206, United States

Location

Susan L. Floyd, MD, PC

Wexford, Pennsylvania, 15090, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Fellows Research Alliance, Inc.

Bluffton, South Carolina, 29910, United States

Location

Practice Research Organization, Inc.

Dallas, Texas, 75230, United States

Location

Radiant Research-Dallas

Dallas, Texas, 75231, United States

Location

Research Across America

Dallas, Texas, 75234, United States

Location

Advances In Health, Inc

Houston, Texas, 77030, United States

Location

Radiant Research-San Antonio

San Antonio, Texas, 78229, United States

Location

Center for Reproductive Medicine

Webster, Texas, 77598, United States

Location

J. Lewis Research-Foothill Family Clinic

Salt Lake City, Utah, 84109, United States

Location

J. Lewis Research - Foothill Family Clinic South

Salt Lake City, Utah, 84121, United States

Location

Physicians' Research Options LLC

Sandy City, Utah, 84070, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23507-1627, United States

Location

Virginia Women's Center

Richmond, Virginia, 23233, United States

Location

Seattle Women's: Health, Research, Gynecology

Seattle, Washington, 98105, United States

Location

North Spokane Women's Clinic

Spokane, Washington, 99207, United States

Location

Results Point of Contact

• Title: Therapeutic Area, Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Anna Chan, PharmD

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2011
• First Posted: October 20, 2011
• Study Start: October 20, 2011
• Primary Completion: December 3, 2012
• Study Completion: December 3, 2012
• Last Updated: May 9, 2022
• Results First Posted: May 9, 2022

Record last verified: 2021-09

Locations

US (64)