MedPath

A One-year Safety Study of Flibanserin to Treat Pre-Menopausal Women With Hypoactive Sexual Desire Disorder (HSDD).

Phase 3
Terminated
Conditions
Sexual Dysfunctions, Psychological
Interventions
Registration Number
NCT00441558
Lead Sponsor
Sprout Pharmaceuticals, Inc
Brief Summary

To determine if long-term treatment with Flibanserin is safe and to monitor the effectiveness of Flibanserin in Women with HSDD that have already completed a previous study (511.70/71/.74/.75/.105) with Flibanserin.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
Female
Target Recruitment
1723
Inclusion Criteria
  1. Women with a primary diagnosis of HSDD who have completed a previous study of Flibanserin.
  2. Patients must have used a medically acceptable method of contraception for at least 2 months before the start of the study and continue to use that method for the duration of the study.
  3. Patients must be reliable, compliant, and agree to cooperate with all study evaluations.
  4. Patients must be able and willing to give meaningful, written informed consent prior to the start of the study and be willing to discuss their sexual functioning with the study staff.
Read More
Exclusion Criteria
  1. A history of Major Depressive Disorder within 6 months prior to the start of the study, current suicidal thoughts, or any history of a suicide attempt.
  2. Participation in another clinical trial within 1 month prior to the start of the study, except for Flibanserin.
  3. Patients with pelvic inflammatory disease, urinary tract infection, vaginal infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant vaginal atrophy.
  4. Patients who are pregnant or have been pregnant within 1 month prior to study start.
  5. Patients experiencing major life stress (including loss of income, death of a family member, major illness, etc.) or relationship trouble that could interfere with sexual activity, except distress about HSDD.
  6. Clinically significant ECG or lab abnormalities at study start.
  7. Patients taking prohibited medications that were excluded in their previous trial which contribute to sexual dysfunction or safety-related interactions.
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
flibanserinFlibanserinflexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
Primary Outcome Measures
NameTimeMethod
The Frequency of Adverse Events (Side Effects).52 weeks

This is a 52-week, open label trial assessing safety/tolerability of flibanserin in women with Hypoactive Sexual Desire Disorder

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (196)

511.84.02015 Boehringer Ingelheim Investigational Site

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Victoria, British Columbia, Canada

511.84.01198 Boehringer Ingelheim Investigational Site

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Houston, Texas, United States

511.84.01012 Boehringer Ingelheim Investigational Site

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Seattle, Washington, United States

511.84.01055 Boehringer Ingelheim Investigational Site

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Miami, Florida, United States

511.84.01092 Boehringer Ingelheim Investigational Site

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Indianapolis, Indiana, United States

511.84.01148 Boehringer Ingelheim Investigational Site

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Las Vegas, Nevada, United States

511.84.01062 Boehringer Ingelheim Investigational Site

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Cincinnati, Ohio, United States

511.84.01197 Boehringer Ingelheim Investigational Site

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Cincinnati, Ohio, United States

511.84.01043 Boehringer Ingelheim Investigational Site

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San Diego, California, United States

511.84.01157 Boehringer Ingelheim Investigational Site

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Mobile, Alabama, United States

511.84.01048 Boehringer Ingelheim Investigational Site

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Tarzana, California, United States

511.84.01142 Boehringer Ingelheim Investigational Site

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Mobile, Alabama, United States

511.84.01052 Boehringer Ingelheim Investigational Site

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Corpus Christi, Texas, United States

511.84.01107 Boehringer Ingelheim Investigational Site

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Norfolk, Virginia, United States

511.84.01093 Boehringer Ingelheim Investigational Site

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Bellevue, Washington, United States

511.84.01131 Boehringer Ingelheim Investigational Site

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Chaska, Minnesota, United States

511.84.01188 Boehringer Ingelheim Investigational Site

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Huntsville, Alabama, United States

511.84.01162 Boehringer Ingelheim Investigational Site

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Little Rock, Alaska, United States

511.84.01006 Boehringer Ingelheim Investigational Site

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Wheatridge, Colorado, United States

511.84.01004 Boehringer Ingelheim Investigational Site

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Englewood, Colorado, United States

511.84.01110 Boehringer Ingelheim Investigational Site

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Mobile, Alabama, United States

511.84.01029 Boehringer Ingelheim Investigational Site

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Walnut Creek, California, United States

511.84.01047 Boehringer Ingelheim Investigational Site

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San Diego, California, United States

511.84.01040 Boehringer Ingelheim Investigational Site

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Stanford, California, United States

511.84.01173 Boehringer Ingelheim Investigational Site

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Vista, California, United States

511.84.01137 Boehringer Ingelheim Investigational Site

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Westlake Village, California, United States

511.84.01087 Boehringer Ingelheim Investigational Site

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Berkeley, California, United States

511.84.01176 Boehringer Ingelheim Investigational Site

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Marietta, Georgia, United States

511.84.01037 Boehringer Ingelheim Investigational Site

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La Jolla, California, United States

511.84.01017 Boehringer Ingelheim Investigational Site

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Torrance, California, United States

511.84.01077 Boehringer Ingelheim Investigational Site

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Encinitas, California, United States

511.84.01104 Boehringer Ingelheim Investigational Site

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Irvine, California, United States

511.84.01096 Boehringer Ingelheim Investigational Site

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San Diego, California, United States

511.84.01074 Boehringer Ingelheim Investigational Site

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Fair Oaks, California, United States

511.84.01023 Boehringer Ingelheim Investigational Site

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Sandy Springs, Georgia, United States

511.84.01061 Boehringer Ingelheim Investigational Site

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Atlanta, Georgia, United States

511.84.01179 Boehringer Ingelheim Investigational Site

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Champaign, Illinois, United States

511.84.01106 Boehringer Ingelheim Investigational Site

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Beachwood, Ohio, United States

511.84.01139 Boehringer Ingelheim Investigational Site

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Roswell, Georgia, United States

511.84.01066 Boehringer Ingelheim Investigational Site

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Poughkeepsie, New York, United States

511.84.01034 Boehringer Ingelheim Investigational Site

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St. Louis, Missouri, United States

511.84.01205 Boehringer Ingelheim Investigational Site

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Atlanta, Georgia, United States

511.84.01113 Boehringer Ingelheim Investigational Site

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Chicago, Illinois, United States

511.84.01172 Boehringer Ingelheim Investigational Site

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Chicago, Illinois, United States

511.84.01121 Boehringer Ingelheim Investigational Site

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New Bern, North Carolina, United States

511.84.01050 Boehringer Ingelheim Investigational Site

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Endwell, New York, United States

511.84.01151 Boehringer Ingelheim Investigational Site

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Columbus, Ohio, United States

511.84.01145 Boehringer Ingelheim Investigational Site

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Pittsburgh, Pennsylvania, United States

511.84.01089 Boehringer Ingelheim Investigational Site

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Cincinnati, Ohio, United States

511.84.01201 Boehringer Ingelheim Investigational Site

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Cincinnati, Ohio, United States

511.84.01021 Boehringer Ingelheim Investigational Site

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Wilkes-Barre, Pennsylvania, United States

511.84.01119 Boehringer Ingelheim Investigational Site

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Raleigh, North Carolina, United States

511.84.01054 Boehringer Ingelheim Investigational Site

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West Reading, Pennsylvania, United States

511.84.01088 Boehringer Ingelheim Investigational Site

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Jenkintown, Pennsylvania, United States

511.84.01136 Boehringer Ingelheim Investigational Site

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Columbus, Ohio, United States

511.84.01149 Boehringer Ingelheim Investigational Site

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Columbus, Ohio, United States

511.84.01185 Boehringer Ingelheim Investigational Site

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Tulsa, Oklahoma, United States

511.84.01067 Boehringer Ingelheim Investigational Site

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Philadelphia, Pennsylvania, United States

511.84.01153 Boehringer Ingelheim Investigational Site

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Philadelphia, Pennsylvania, United States

511.84.01014 Boehringer Ingelheim Investigational Site

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Cleveland, Ohio, United States

511.84.01112 Planned Parenthood of Arkansas & Estrn Oklahoma, Inc

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Tulsa, Oklahoma, United States

511.84.02017 Boehringer Ingelheim Investigational Site

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Winnipeg, Manitoba, Canada

511.84.01079 Boehringer Ingelheim Investigational Site

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Birmingham, Alabama, United States

511.84.01191 Boehringer Ingelheim Investigational Site

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Phoenix, Arizona, United States

511.84.01190 Boehringer Ingelheim Investigational Site

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Oklahoma City, Oklahoma, United States

511.84.01193 Boehringer Ingelheim Investigational Site

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Birmingham, Alabama, United States

511.84.01070 Boehringer Ingelheim Investigational Site

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Phoenix, Arizona, United States

511.84.01041 Boehringer Ingelheim Investigational Site

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Detroit, Michigan, United States

511.84.01103 Boehringer Ingelheim Investigational Site

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Portland, Oregon, United States

511.84.01026 Boehringer Ingelheim Investigational Site

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Nashville, Tennessee, United States

511.84.01015 Boehringer Ingelheim Investigational Site

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Salt Lake City, Utah, United States

511.84.01071 Boehringer Ingelheim Investigational Site

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San Antonio, Texas, United States

511.84.01083 Boehringer Ingelheim Investigational Site

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San Antonio, Texas, United States

511.84.01086 Boehringer Ingelheim Investigational Site

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San Antonio, Texas, United States

511.84.01164 Boehringer Ingelheim Investigational Site

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Denver, Colorado, United States

511.84.01184 Boehringer Ingelheim Investigational Site

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Denver, Colorado, United States

511.84.01100 Boehringer Ingelheim Investigational Site

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Nashville, Tennessee, United States

511.84.01069 Boehringer Ingelheim Investigational Site

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Gainsville, Florida, United States

511.84.01159 Boehringer Ingelheim Investigational Site

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Tampa, Florida, United States

511.84.01170 Boehringer Ingelheim Investigational Site

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Tampa, Florida, United States

511.84.01183 Boehringer Ingelheim Investigational Site

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Tampa, Florida, United States

511.84.01090 Boehringer Ingelheim Investigational Site

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Aurora, Colorado, United States

511.84.01108 Boehringer Ingelheim Investigational Site

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New Britain, Connecticut, United States

511.84.01169 Boehringer Ingelheim Investigational Site

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Daytona Beach, Florida, United States

511.84.01182 Boehringer Ingelheim Investigational Site

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New Port Richey, Florida, United States

511.84.01175 Boehringer Ingelheim Investigational Site

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Sarasota, Florida, United States

511.84.01032 Boehringer Ingelheim Investigational Site

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Plantation, Florida, United States

511.84.01022 Boehringer Ingelheim Investigational Site

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West Palm Beach, Florida, United States

511.84.01024 Boehringer Ingelheim Investigational Site

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Atlanta, Georgia, United States

511.84.01165 Boehringer Ingelheim Investigational Site

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Chicago, Illinois, United States

511.84.01120 Boehringer Ingelheim Investigational Site

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Brighton, Massachusetts, United States

511.84.01128 Boehringer Ingelheim Investigational Site

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Chesterfield, Missouri, United States

511.84.01081 Boehringer Ingelheim Investigational Site

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Bingham Farms, Michigan, United States

511.84.01030 Boehringer Ingelheim Investigational Site

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Haverhill, Massachusetts, United States

511.84.01045 Boehringer Ingelheim Investigational Site

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Albequerque, New Mexico, United States

511.84.01187 Boehringer Ingelheim Investigational Site

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Purchase, New York, United States

511.84.01008 Boehringer Ingelheim Investigational Site

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Cincinnati, Ohio, United States

511.84.01009 Boehringer Ingelheim Investigational Site

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Cleveland, Ohio, United States

511.84.01152 Boehringer Ingelheim Investigational Site

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Cleveland, Ohio, United States

511.84.01060 Boehringer Ingelheim Investigational Site

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Warwick, Rhode Island, United States

511.84.01063 Boehringer Ingelheim Investigational Site

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Anderson, South Carolina, United States

511.84.01124 Boehringer Ingelheim Investigational Site

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Columbia, South Carolina, United States

511.84.01123 Boehringer Ingelheim Investigational Site

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Greenville, South Carolina, United States

511.84.01163 Boehringer Ingelheim Investigational Site

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Knoxville, Tennessee, United States

511.84.01174 Boehringer Ingelheim Investigational Site

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Germantown, Tennessee, United States

511.84.01027 Boehringer Ingelheim Investigational Site

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Dallas, Texas, United States

511.84.01140 Boehringer Ingelheim Investigational Site

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Dallas, Texas, United States

511.84.01057 Boehringer Ingelheim Investigational Site

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Houston, Texas, United States

511.84.01084 Boehringer Ingelheim Investigational Site

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Fort Worth, Texas, United States

511.84.01036 Boehringer Ingelheim Investigational Site

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San Antonio, Texas, United States

511.84.01082 Boehringer Ingelheim Investigational Site

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Houston, Texas, United States

511.84.01098 Boehringer Ingelheim Investigational Site

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Waco, Texas, United States

511.84.01180 Boehringer Ingelheim Investigational Site

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Sandy, Utah, United States

511.84.01031 Boehringer Ingelheim Investigational Site

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Charlottesville, Virginia, United States

511.84.01028 Boehringer Ingelheim Investigational Site

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Burlington, Vermont, United States

511.84.01035 Boehringer Ingelheim Investigational Site

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Charlottesville, Virginia, United States

511.84.01125 Boehringer Ingelheim Investigational Site

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Norfolk, Virginia, United States

511.84.01116 Boehringer Ingelheim Investigational Site

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Spokane, Washington, United States

511.84.01141 Boehringer Ingelheim Investigational Site

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Renton, Washington, United States

511.84.01105 Boehringer Ingelheim Investigational Site

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Tacoma, Washington, United States

511.84.01177 Boehringer Ingelheim Investigational Site

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Middleton, Wisconsin, United States

511.84.02014 Boehringer Ingelheim Investigational Site

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Coquitlam, British Columbia, Canada

511.84.02002 Boehringer Ingelheim Investigational Site

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North Vancouver, British Columbia, Canada

511.84.01013 Boehringer Ingelheim Investigational Site

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Jonesboro, Arkansas, United States

511.84.01016 Boehringer Ingelheim Investigational Site

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Hartford, Connecticut, United States

511.84.01085 Boehringer Ingelheim Investigational Site

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Fort Lauderdale, Florida, United States

511.84.01144 Boehringer Ingelheim Investigational Site

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Coral Gables, Florida, United States

511.84.01146 Boehringer Ingelheim Investigational Site

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Clearwater, Florida, United States

511.84.01194 Boehringer Ingelheim Investigational Site

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Fort Meyers, Florida, United States

511.84.01138 Boehringer Ingelheim Investigational Site

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Farmington, Connecticut, United States

511.84.01065 Boehringer Ingelheim Investigational Site

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Aventura, Florida, United States

511.84.01115 Boehringer Ingelheim Investigational Site

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Tucson, Arizona, United States

511.84.01156 Boehringer Ingelheim Investigational Site

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Omaha, Nebraska, United States

511.84.01044 Boehringer Ingelheim Investigational Site

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Groton, Connecticut, United States

511.84.01171 Boehringer Ingelheim Investigational Site

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Lafayette, Louisiana, United States

511.84.01025 Boehringer Ingelheim Investigational Site

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Baton Rouge, Louisiana, United States

511.84.01135 Boehringer Ingelheim Investigational Site

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Pembroke Pines, Florida, United States

511.84.01160 Boehringer Ingelheim Investigational Site

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Washington, District of Columbia, United States

511.84.01064 Boehringer Ingelheim Investigational Site

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Miami, Florida, United States

511.84.02020 Boehringer Ingelheim Investigational Site

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Quebec, Canada

511.84.01166 Boehringer Ingelheim Investigational Site

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Newark, Delaware, United States

511.84.01109 Boehringer Ingelheim Investigational Site

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Mt. Pleasant, South Carolina, United States

511.84.02005 Boehringer Ingelheim Investigational Site

๐Ÿ‡จ๐Ÿ‡ฆ

Sherbrooke, Quebec, Canada

511.84.01053 Boehringer Ingelheim Investigational Site

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St. Petersburg, Florida, United States

511.84.01132 Boehringer Ingelheim Investigational Site

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St. Petersburg, Florida, United States

511.84.01206 Boehringer Ingelheim Investigational Site

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Moorestown, New Jersey, United States

511.84.01117 Boehringer Ingelheim Investigational Site

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Stuart, Florida, United States

511.84.01005 Boehringer Ingelheim Investigational Site

๐Ÿ‡บ๐Ÿ‡ธ

Boynton Beach, Florida, United States

511.84.01007 Boehringer Ingelheim Investigational Site

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Hudson, Florida, United States

511.84.01167 Boehringer Ingelheim Investigational Site

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Ocala, Florida, United States

511.84.01168 Boehringer Ingelheim Investigational Site

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New London, Connecticut, United States

511.84.01147 Boehringer Ingelheim Investigational Site

๐Ÿ‡บ๐Ÿ‡ธ

Bingham Farms, Michigan, United States

511.84.02010 Boehringer Ingelheim Investigational Site

๐Ÿ‡จ๐Ÿ‡ฆ

Woodstock, New Brunswick, Canada

511.84.02011 Boehringer Ingelheim Investigational Site

๐Ÿ‡จ๐Ÿ‡ฆ

Montrรฉal, Quebec, Canada

511.84.02019 Boehringer Ingelheim Investigational Site

๐Ÿ‡จ๐Ÿ‡ฆ

Quรฉbec, Quebec, Canada

511.84.02023 Boehringer Ingelheim Investigational Site

๐Ÿ‡จ๐Ÿ‡ฆ

Victoria, British Columbia, Canada

511.84.02003 Boehringer Ingelheim Investigational Site

๐Ÿ‡จ๐Ÿ‡ฆ

Halifax, Nova Scotia, Canada

511.84.01003 Boehringer Ingelheim Investigational Site

๐Ÿ‡บ๐Ÿ‡ธ

West Palm Beach, Florida, United States

511.84.01042 Boehringer Ingelheim Investigational Site

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Billings, Montana, United States

511.84.02022 Boehringer Ingelheim Investigational Site

๐Ÿ‡จ๐Ÿ‡ฆ

London, Ontario, Canada

511.84.02024 Boehringer Ingelheim Investigational Site

๐Ÿ‡จ๐Ÿ‡ฆ

London, Ontario, Canada

511.84.02008 Boehringer Ingelheim Investigational Site

๐Ÿ‡จ๐Ÿ‡ฆ

Ottawa, Ontario, Canada

511.84.02012 Boehringer Ingelheim Investigational Site

๐Ÿ‡จ๐Ÿ‡ฆ

Mount Pearl, Newfoundland and Labrador, Canada

511.84.01130 Boehringer Ingelheim Investigational Site

๐Ÿ‡บ๐Ÿ‡ธ

New Orlean, Louisiana, United States

511.84.01001 Boehringer Ingelheim Investigational Site

๐Ÿ‡บ๐Ÿ‡ธ

Baltimore, Maryland, United States

511.84.02013 Boehringer Ingelheim Investigational Site

๐Ÿ‡จ๐Ÿ‡ฆ

Vancouver, British Columbia, Canada

511.84.02021 Boehringer Ingelheim Investigational Site

๐Ÿ‡จ๐Ÿ‡ฆ

Surrey, British Columbia, Canada

511.84.02004 Boehringer Ingelheim Investigational Site

๐Ÿ‡จ๐Ÿ‡ฆ

Saskatoon, Saskatchewan, Canada

511.84.02009 Boehringer Ingelheim Investigational Site

๐Ÿ‡จ๐Ÿ‡ฆ

Burlington, Ontario, Canada

511.84.01134 Boehringer Ingelheim Investigational Site

๐Ÿ‡บ๐Ÿ‡ธ

Medfod, Oregon, United States

511.84.01010 Boehringer Ingelheim Investigational Site

๐Ÿ‡บ๐Ÿ‡ธ

New Brunswick, New Jersey, United States

511.84.02007 Boehringer Ingelheim Investigational Site

๐Ÿ‡จ๐Ÿ‡ฆ

Calgary, Alberta, Canada

511.84.01019 Boehringer Ingelheim Investigational Site

๐Ÿ‡บ๐Ÿ‡ธ

Eugene, Oregon, United States

511.84.02018 Boehringer Ingelheim Investigational Site

๐Ÿ‡จ๐Ÿ‡ฆ

Barrie, Ontario, Canada

511.84.01056 Boehringer Ingelheim Investigational Site

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Sacramento, California, United States

511.84.01127 Boehringer Ingelheim Investigational Site

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Ann Arbor, Michigan, United States

511.84.01195 Boehringer Ingelheim Investigational Site

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Sacramento, California, United States

511.84.01072 Boehringer Ingelheim Investigational Site

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Winston-Salem, North Carolina, United States

511.84.01111 Boehringer Ingelheim Investigational Site

๐Ÿ‡บ๐Ÿ‡ธ

Orlando, Florida, United States

511.84.01118 Boehringer Ingelheim Investigational Site

๐Ÿ‡บ๐Ÿ‡ธ

Orlando, Florida, United States

511.84.01192 Boehringer Ingelheim Investigational Site

๐Ÿ‡บ๐Ÿ‡ธ

New Orleans, Louisiana, United States

511.84.01051 Boehringer Ingelheim Investigational Site

๐Ÿ‡บ๐Ÿ‡ธ

Kansas City, Missouri, United States

511.84.01178 Boehringer Ingelheim Investigational Site

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Chapel Hill, North Carolina, United States

511.84.01078 Boehringer Ingelheim Investigational Site

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Austin, Texas, United States

511.84.01076 Boehringer Ingelheim Investigational Site

๐Ÿ‡บ๐Ÿ‡ธ

Richmond, Virginia, United States

511.84.01097 Boehringer Ingelheim Investigational Site

๐Ÿ‡บ๐Ÿ‡ธ

Richmond, Virginia, United States

511.84.01196 Boehringer Ingelheim Investigational Site

๐Ÿ‡บ๐Ÿ‡ธ

Richmond, Virginia, United States

511.84.01002 Boehringer Ingelheim Investigational Site

๐Ÿ‡บ๐Ÿ‡ธ

Gainesville, Florida, United States

511.84.01202 Boehringer Ingelheim Investigational Site

๐Ÿ‡บ๐Ÿ‡ธ

Wichita, Kansas, United States

511.84.01049 Boehringer Ingelheim Investigational Site

๐Ÿ‡บ๐Ÿ‡ธ

Lexington, Kentucky, United States

511.84.01059 Boehringer Ingelheim Investigational Site

๐Ÿ‡บ๐Ÿ‡ธ

Bronx, New York, United States

511.84.01038 Boehringer Ingelheim Investigational Site

๐Ÿ‡บ๐Ÿ‡ธ

Rochester, New York, United States

511.84.01150 Boehringer Ingelheim Investigational Site

๐Ÿ‡บ๐Ÿ‡ธ

Dayton, Ohio, United States

511.84.02001 Boehringer Ingelheim Investigational Site

๐Ÿ‡จ๐Ÿ‡ฆ

Ottawa, Ontario, Canada

511.84.02006 Boehringer Ingelheim Investigational Site

๐Ÿ‡จ๐Ÿ‡ฆ

St. John's, Newfoundland and Labrador, Canada

511.84.01143 Boehringer Ingelheim Investigational Site

๐Ÿ‡บ๐Ÿ‡ธ

Evansville, Indiana, United States

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