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

April 11, 2022 updated by: Warner Chilcott

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
722

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Medical Affiliated Research Center, Inc.
      • Mobile, Alabama, United States, 36608
        • Mobile Ob-Gyn, PC
    • Arizona
      • Phoenix, Arizona, United States, 85015
        • Women's Health Research
      • Phoenix, Arizona, United States, 85032
        • Precision Trials, LLC
      • Scottsdale, Arizona, United States, 85251
        • Radiant Research-Scottsdale
      • Tucson, Arizona, United States, 85712
        • Visions Clinical Research-Tucson
      • Tucson, Arizona, United States, 85710
        • Radiant Research-Tucson
    • California
      • San Diego, California, United States, 92108
        • Medical Center for Clinical Research
      • San Diego, California, United States, 92103
        • Genesis Center for Clinical Research
      • San Diego, California, United States, 92123
        • Women's Healthcare Inc.
    • Colorado
      • Lakewood, Colorado, United States, 80228
        • Physicians' Research Options LLC
    • Connecticut
      • New London, Connecticut, United States, 06320
        • Costal Connecticut Resarch, LLC
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Visions Clinical Research
      • Clearwater, Florida, United States, 33759
        • Women's Medical Research Group, LLC
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
      • Miami, Florida, United States, 33143
        • Miami Research Associates
      • Miami, Florida, United States, 33186
        • New Age Medical Research Corp
      • Ormond Beach, Florida, United States, 32174
        • Ormond Medical Arts Pharmaceutical Research Center
      • Palm Beach Gardens, Florida, United States, 33410
        • OB-GYN Specialists of the Palm
      • Pinellas Park, Florida, United States, 33781
        • Radiant Research-St. Petersburg
      • West Palm Beach, Florida, United States, 33409
        • Comprehensive Clinical Trials, Llc
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Radiant Research-Atlanta
      • Decatur, Georgia, United States, 30034
        • Soapstone Center for Clinical Research
      • Roswell, Georgia, United States, 30075
        • Atlanta North Gynecology, PC
      • Savannah, Georgia, United States, 31406
        • Fellows Research Alliance, Inc.
    • Illinois
      • Chicago, Illinois, United States, 60654
        • Radiant Research-Chicago
      • Springfield, Illinois, United States, 62703
        • Springfield Clinical, LLP
    • Indiana
      • Granger, Indiana, United States, 46530
        • The South Bend Clinic, LLP
    • Kansas
      • Overland Park, Kansas, United States, 66202
        • Radiant Research - Overland Park
      • Wichita, Kansas, United States, 67207
        • Heartland Research Associates
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
        • Kentucky Pediatric Research, Inc.
      • Louisville, Kentucky, United States, 40291
        • Bluegrass Clinical Research, Inc.
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • York Clinical Consulting
      • New Orleans, Louisiana, United States, 70115
        • Women Under Study
    • Michigan
      • Kalamazoo, Michigan, United States, 49009
        • Beyer Research
    • Minnesota
      • Chaska, Minnesota, United States, 55318
        • Ridgeview Research Two Twelve Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Affiliated Clinical Research
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Lawrence OB-GYN Associates, P.C.
      • Moorestown, New Jersey, United States, 08051
        • Phoenix OB-GYN Assoc., LLC
      • Plainsboro, New Jersey, United States, 08536
        • The Center for Women's Health and Wellness, LLC
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
        • Hawthorne Medical Research, Inc.
      • New Bern, North Carolina, United States, 28562
        • Eastern Carolina Women's Center
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates, LLC
      • Winston-Salem, North Carolina, United States, 27103
        • Lyndhurst Clinical Research
      • Winston-Salem, North Carolina, United States, 27103
        • Hawthorne Medical Research, Inc.
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • Rapid Medical Research, Inc.
      • Columbus, Ohio, United States, 43213
        • The Columbus Center for Women's Health Research
      • Englewood, Ohio, United States, 45322
        • HWC - Women's Research Center
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Clinical Trials of America, Inc.
      • Medford, Oregon, United States, 97504
        • Advanced Clinical Research
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 19046
        • The Clinical Trial Center, LLC
      • Philadelphia, Pennsylvania, United States, 19114
        • Philadelphia Clinical Research, LLC
      • Pittsburgh, Pennsylvania, United States, 15206
        • Clinical Trials Research Services, LLC
      • Wexford, Pennsylvania, United States, 15090
        • Susan L. Floyd, MD, PC
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Omega Medical Research
    • South Carolina
      • Bluffton, South Carolina, United States, 29910
        • Fellows Research Alliance, Inc.
      • Columbia, South Carolina, United States, 29201
        • SC Clinical Research Center, LLC
    • Texas
      • Dallas, Texas, United States, 75230
        • Practice Research Organization, Inc.
      • Dallas, Texas, United States, 75231
        • Radiant Research-Dallas
      • Dallas, Texas, United States, 75234
        • Research Across America RHD Professional Plaza 4
      • Houston, Texas, United States, 77030
        • Advances In Health, Inc.
      • San Antonio, Texas, United States, 78229
        • Radiant Research-San Antonio
      • Webster, Texas, United States, 77598
        • Center for Reproductive Medicine
    • Utah
      • Salt Lake City, Utah, United States, 84109
        • J. Lewis Research-Foothill Family Clinic
      • Salt Lake City, Utah, United States, 84121
        • J. Lewis Research - Foothill Family Clinic South
      • Sandy, Utah, United States, 84070
        • Physicians' Research Options LLC
    • Virginia
      • Norfolk, Virginia, United States, 23507-1627
        • Eastern Virginia Medical School
      • Richmond, Virginia, United States, 23233
        • Virginia Women's Center
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Women's: Health, Research Gynecology
      • Spokane, Washington, United States, 99207
        • North Spokane Women's Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: WC3011 Estradiol Vaginal Cream (2 Times/Week)
WC3011 estradiol vaginal cream applied daily for 2 weeks, followed by dosing 2 times a week for 10 weeks.
Drug: WC3011 Estradiol Vaginal Cream
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
Placebo Comparator: Vehicle (2 Times/Week)
Vehicle applied daily for 2 weeks, followed by dosing 2 times a week for 10 weeks.
Drug: Vehicle
Vehicle administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks.
Experimental: WC3011 Estradiol Vaginal Cream (3 Times/Week)
WC3011 estradiol vaginal cream applied daily for 2 weeks, followed by dosing 3 times a week for 10 weeks.
Drug: WC3011 Estradiol Vaginal Cream
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
Placebo Comparator: Vehicle (3 Times/Week)
Vehicle applied daily for 2 weeks, followed by dosing 3 times a week for 10 weeks.
Drug: Vehicle
Vehicle administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (Day 0) to Week 12/Final Visit
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.
Baseline (Day 0) to Week 12/Final Visit
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.
Baseline (Day 0) to Week 12/Final Visit
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.
Baseline (Day 0) to Week 12/Final Visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
Baseline (Day 0) to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Warner Chilcott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 29, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 27, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 27, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PR-04409.3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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