Safety & Efficacy WC3011 (Estradiol Vaginal Cream) in the Treatment of Vulvovaginal Atrophy in Postmenopausal Women

NCT01400776 | Completed Phase 3 Results FDA Drug

• 1 other identifier: PR-04409.3
• Study Type: interventional
• Target: 722
• Locations: 1 country
• Sites: 70

Brief Summary

Study if WC3011 is effective and safe in the treatment of postmenopausal vaginal dryness due to vulvovaginal atrophy.

Conditions

Postmenopausal Vulvovaginal Atrophy

Keywords

Postmenopausal Women, Vaginal Dryness

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  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

  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

  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

  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

  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

  Baseline (Day 0) to Week 12 and Week 12/Final visit

Study Arms (4)

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.

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.

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.

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.

Drug: Vehicle

Interventions

WC3011 Estradiol Vaginal Cream DRUG

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

WC3011 Estradiol Vaginal Cream (2 Times/Week); WC3011 Estradiol Vaginal Cream (3 Times/Week)

Vehicle DRUG

Vehicle administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks.

Vehicle (2 Times/Week); Vehicle (3 Times/Week)

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal females ≥35 years with either or both ovaries removed or naturally menopausal with moderate to severe vaginal dryness

You may not qualify if:

• 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

Sponsors & Collaborators

• Warner Chilcott: lead

Study Sites (70)

Medical Affiliated Research Center, Inc.

Huntsville, Alabama, 35801, United States

Location

Mobile OB-GYN, PC

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

Physicians' Research Options LLC

Lakewood, Colorado, 80228, United States

Location

Costal Connecticut Resarch, 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

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

Soapstone Center for Clinical Research

Decatur, Georgia, 30034, United States

Location

Atlanta North Gynecology, PC

Roswell, Georgia, 30075, 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

Kentucky Pediatric Research, Inc.

Bardstown, Kentucky, 40004, 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 Two Twelve Medical Center

Chaska, Minnesota, 55318, United States

Location

Affiliated Clinical Research

Las Vegas, Nevada, 89106, United States

Location

Lawrence OB-GYN Associates, P.C.

Lawrenceville, New Jersey, 08648, United States

Location

Phoenix OB-GYN Assoc., LLC

Moorestown, New Jersey, 08051, United States

Location

The Center for Women's Health and Wellness, LLC

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

HWC - Women's Research Center

Englewood, Ohio, 45322, United States

Location

Clinical Trials of America, Inc.

Eugene, Oregon, 97401, United States

Location

Advanced Clinical Research

Medford, Oregon, 97504, United States

Location

The Clinical Trial Center, LLC

Jenkintown, Pennsylvania, 19046, 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

SC Clinical Research Center, LLC

Columbia, South Carolina, 29201, 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 RHD Professional Plaza 4

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: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2011
• First Posted: July 22, 2011
• Study Start: June 29, 2011
• Primary Completion: February 27, 2012
• Study Completion: February 27, 2012
• Last Updated: May 9, 2022
• Results First Posted: May 9, 2022

Record last verified: 2021-09

Locations

US (70)