- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00441558
En et-årig sikkerhedsundersøgelse af Flibanserin til behandling af præmenopausale kvinder med hypoaktiv seksuel lystsforstyrrelse (HSDD).
14. maj 2014 opdateret af: Sprout Pharmaceuticals, Inc
Verdensomspændende etårig åbent sikkerhedsundersøgelse af Flibanserin hos kvinder med HSDD
For at afgøre, om langtidsbehandling med Flibanserin er sikker, og for at overvåge effektiviteten af Flibanserin hos kvinder med HSDD, som allerede har gennemført en tidligere undersøgelse (511.70/71/.74/.75/.105) med Flibanserin.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1723
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Quebec, Canada
- 511.84.02020 Boehringer Ingelheim Investigational Site
-
-
Alberta
-
Calgary, Alberta, Canada
- 511.84.02007 Boehringer Ingelheim Investigational Site
-
-
British Columbia
-
Coquitlam, British Columbia, Canada
- 511.84.02014 Boehringer Ingelheim Investigational Site
-
North Vancouver, British Columbia, Canada
- 511.84.02002 Boehringer Ingelheim Investigational Site
-
Surrey, British Columbia, Canada
- 511.84.02021 Boehringer Ingelheim Investigational Site
-
Vancouver, British Columbia, Canada
- 511.84.02013 Boehringer Ingelheim Investigational Site
-
Victoria, British Columbia, Canada
- 511.84.02015 Boehringer Ingelheim Investigational Site
-
Victoria, British Columbia, Canada
- 511.84.02023 Boehringer Ingelheim Investigational Site
-
-
Manitoba
-
Winnipeg, Manitoba, Canada
- 511.84.02017 Boehringer Ingelheim Investigational Site
-
-
New Brunswick
-
Woodstock, New Brunswick, Canada
- 511.84.02010 Boehringer Ingelheim Investigational Site
-
-
Newfoundland and Labrador
-
Mount Pearl, Newfoundland and Labrador, Canada
- 511.84.02012 Boehringer Ingelheim Investigational Site
-
St. John's, Newfoundland and Labrador, Canada
- 511.84.02006 Boehringer Ingelheim Investigational Site
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada
- 511.84.02003 Boehringer Ingelheim Investigational Site
-
-
Ontario
-
Barrie, Ontario, Canada
- 511.84.02018 Boehringer Ingelheim Investigational Site
-
Burlington, Ontario, Canada
- 511.84.02009 Boehringer Ingelheim Investigational Site
-
London, Ontario, Canada
- 511.84.02022 Boehringer Ingelheim Investigational Site
-
London, Ontario, Canada
- 511.84.02024 Boehringer Ingelheim Investigational Site
-
Ottawa, Ontario, Canada
- 511.84.02001 Boehringer Ingelheim Investigational Site
-
Ottawa, Ontario, Canada
- 511.84.02008 Boehringer Ingelheim Investigational Site
-
-
Quebec
-
Montréal, Quebec, Canada
- 511.84.02011 Boehringer Ingelheim Investigational Site
-
Québec, Quebec, Canada
- 511.84.02019 Boehringer Ingelheim Investigational Site
-
Sherbrooke, Quebec, Canada
- 511.84.02005 Boehringer Ingelheim Investigational Site
-
-
Saskatchewan
-
Saskatoon, Saskatchewan, Canada
- 511.84.02004 Boehringer Ingelheim Investigational Site
-
-
-
-
Alabama
-
Birmingham, Alabama, Forenede Stater
- 511.84.01079 Boehringer Ingelheim Investigational Site
-
Birmingham, Alabama, Forenede Stater
- 511.84.01193 Boehringer Ingelheim Investigational Site
-
Huntsville, Alabama, Forenede Stater
- 511.84.01188 Boehringer Ingelheim Investigational Site
-
Mobile, Alabama, Forenede Stater
- 511.84.01110 Boehringer Ingelheim Investigational Site
-
Mobile, Alabama, Forenede Stater
- 511.84.01142 Boehringer Ingelheim Investigational Site
-
Mobile, Alabama, Forenede Stater
- 511.84.01157 Boehringer Ingelheim Investigational Site
-
-
Alaska
-
Little Rock, Alaska, Forenede Stater
- 511.84.01162 Boehringer Ingelheim Investigational Site
-
-
Arizona
-
Phoenix, Arizona, Forenede Stater
- 511.84.01070 Boehringer Ingelheim Investigational Site
-
Phoenix, Arizona, Forenede Stater
- 511.84.01191 Boehringer Ingelheim Investigational Site
-
Tucson, Arizona, Forenede Stater
- 511.84.01115 Boehringer Ingelheim Investigational Site
-
-
Arkansas
-
Jonesboro, Arkansas, Forenede Stater
- 511.84.01013 Boehringer Ingelheim Investigational Site
-
-
California
-
Berkeley, California, Forenede Stater
- 511.84.01087 Boehringer Ingelheim Investigational Site
-
Encinitas, California, Forenede Stater
- 511.84.01077 Boehringer Ingelheim Investigational Site
-
Fair Oaks, California, Forenede Stater
- 511.84.01074 Boehringer Ingelheim Investigational Site
-
Irvine, California, Forenede Stater
- 511.84.01104 Boehringer Ingelheim Investigational Site
-
La Jolla, California, Forenede Stater
- 511.84.01037 Boehringer Ingelheim Investigational Site
-
Sacramento, California, Forenede Stater
- 511.84.01056 Boehringer Ingelheim Investigational Site
-
Sacramento, California, Forenede Stater
- 511.84.01195 Boehringer Ingelheim Investigational Site
-
San Diego, California, Forenede Stater
- 511.84.01043 Boehringer Ingelheim Investigational Site
-
San Diego, California, Forenede Stater
- 511.84.01047 Boehringer Ingelheim Investigational Site
-
San Diego, California, Forenede Stater
- 511.84.01096 Boehringer Ingelheim Investigational Site
-
Stanford, California, Forenede Stater
- 511.84.01040 Boehringer Ingelheim Investigational Site
-
Tarzana, California, Forenede Stater
- 511.84.01048 Boehringer Ingelheim Investigational Site
-
Torrance, California, Forenede Stater
- 511.84.01017 Boehringer Ingelheim Investigational Site
-
Vista, California, Forenede Stater
- 511.84.01173 Boehringer Ingelheim Investigational Site
-
Walnut Creek, California, Forenede Stater
- 511.84.01029 Boehringer Ingelheim Investigational Site
-
Westlake Village, California, Forenede Stater
- 511.84.01137 Boehringer Ingelheim Investigational Site
-
-
Colorado
-
Aurora, Colorado, Forenede Stater
- 511.84.01090 Boehringer Ingelheim Investigational Site
-
Denver, Colorado, Forenede Stater
- 511.84.01164 Boehringer Ingelheim Investigational Site
-
Denver, Colorado, Forenede Stater
- 511.84.01184 Boehringer Ingelheim Investigational Site
-
Englewood, Colorado, Forenede Stater
- 511.84.01004 Boehringer Ingelheim Investigational Site
-
Wheatridge, Colorado, Forenede Stater
- 511.84.01006 Boehringer Ingelheim Investigational Site
-
-
Connecticut
-
Farmington, Connecticut, Forenede Stater
- 511.84.01138 Boehringer Ingelheim Investigational Site
-
Groton, Connecticut, Forenede Stater
- 511.84.01044 Boehringer Ingelheim Investigational Site
-
Hartford, Connecticut, Forenede Stater
- 511.84.01016 Boehringer Ingelheim Investigational Site
-
New Britain, Connecticut, Forenede Stater
- 511.84.01108 Boehringer Ingelheim Investigational Site
-
New London, Connecticut, Forenede Stater
- 511.84.01168 Boehringer Ingelheim Investigational Site
-
-
Delaware
-
Newark, Delaware, Forenede Stater
- 511.84.01166 Boehringer Ingelheim Investigational Site
-
-
District of Columbia
-
Washington, District of Columbia, Forenede Stater
- 511.84.01160 Boehringer Ingelheim Investigational Site
-
-
Florida
-
Aventura, Florida, Forenede Stater
- 511.84.01065 Boehringer Ingelheim Investigational Site
-
Boynton Beach, Florida, Forenede Stater
- 511.84.01005 Boehringer Ingelheim Investigational Site
-
Clearwater, Florida, Forenede Stater
- 511.84.01146 Boehringer Ingelheim Investigational Site
-
Coral Gables, Florida, Forenede Stater
- 511.84.01144 Boehringer Ingelheim Investigational Site
-
Daytona Beach, Florida, Forenede Stater
- 511.84.01169 Boehringer Ingelheim Investigational Site
-
Fort Lauderdale, Florida, Forenede Stater
- 511.84.01085 Boehringer Ingelheim Investigational Site
-
Fort Meyers, Florida, Forenede Stater
- 511.84.01194 Boehringer Ingelheim Investigational Site
-
Gainesville, Florida, Forenede Stater
- 511.84.01002 Boehringer Ingelheim Investigational Site
-
Gainsville, Florida, Forenede Stater
- 511.84.01069 Boehringer Ingelheim Investigational Site
-
Hudson, Florida, Forenede Stater
- 511.84.01007 Boehringer Ingelheim Investigational Site
-
Miami, Florida, Forenede Stater
- 511.84.01055 Boehringer Ingelheim Investigational Site
-
Miami, Florida, Forenede Stater
- 511.84.01064 Boehringer Ingelheim Investigational Site
-
New Port Richey, Florida, Forenede Stater
- 511.84.01182 Boehringer Ingelheim Investigational Site
-
Ocala, Florida, Forenede Stater
- 511.84.01167 Boehringer Ingelheim Investigational Site
-
Orlando, Florida, Forenede Stater
- 511.84.01111 Boehringer Ingelheim Investigational Site
-
Orlando, Florida, Forenede Stater
- 511.84.01118 Boehringer Ingelheim Investigational Site
-
Pembroke Pines, Florida, Forenede Stater
- 511.84.01135 Boehringer Ingelheim Investigational Site
-
Plantation, Florida, Forenede Stater
- 511.84.01032 Boehringer Ingelheim Investigational Site
-
Sarasota, Florida, Forenede Stater
- 511.84.01175 Boehringer Ingelheim Investigational Site
-
St. Petersburg, Florida, Forenede Stater
- 511.84.01053 Boehringer Ingelheim Investigational Site
-
St. Petersburg, Florida, Forenede Stater
- 511.84.01132 Boehringer Ingelheim Investigational Site
-
Stuart, Florida, Forenede Stater
- 511.84.01117 Boehringer Ingelheim Investigational Site
-
Tampa, Florida, Forenede Stater
- 511.84.01159 Boehringer Ingelheim Investigational Site
-
Tampa, Florida, Forenede Stater
- 511.84.01170 Boehringer Ingelheim Investigational Site
-
Tampa, Florida, Forenede Stater
- 511.84.01183 Boehringer Ingelheim Investigational Site
-
West Palm Beach, Florida, Forenede Stater
- 511.84.01003 Boehringer Ingelheim Investigational Site
-
West Palm Beach, Florida, Forenede Stater
- 511.84.01022 Boehringer Ingelheim Investigational Site
-
-
Georgia
-
Atlanta, Georgia, Forenede Stater
- 511.84.01024 Boehringer Ingelheim Investigational Site
-
Atlanta, Georgia, Forenede Stater
- 511.84.01061 Boehringer Ingelheim Investigational Site
-
Atlanta, Georgia, Forenede Stater
- 511.84.01205 Boehringer Ingelheim Investigational Site
-
Marietta, Georgia, Forenede Stater
- 511.84.01176 Boehringer Ingelheim Investigational Site
-
Roswell, Georgia, Forenede Stater
- 511.84.01139 Boehringer Ingelheim Investigational Site
-
Sandy Springs, Georgia, Forenede Stater
- 511.84.01023 Boehringer Ingelheim Investigational Site
-
-
Illinois
-
Champaign, Illinois, Forenede Stater
- 511.84.01179 Boehringer Ingelheim Investigational Site
-
Chicago, Illinois, Forenede Stater
- 511.84.01113 Boehringer Ingelheim Investigational Site
-
Chicago, Illinois, Forenede Stater
- 511.84.01165 Boehringer Ingelheim Investigational Site
-
Chicago, Illinois, Forenede Stater
- 511.84.01172 Boehringer Ingelheim Investigational Site
-
-
Indiana
-
Evansville, Indiana, Forenede Stater
- 511.84.01143 Boehringer Ingelheim Investigational Site
-
Indianapolis, Indiana, Forenede Stater
- 511.84.01092 Boehringer Ingelheim Investigational Site
-
-
Kansas
-
Wichita, Kansas, Forenede Stater
- 511.84.01202 Boehringer Ingelheim Investigational Site
-
-
Kentucky
-
Lexington, Kentucky, Forenede Stater
- 511.84.01049 Boehringer Ingelheim Investigational Site
-
-
Louisiana
-
Baton Rouge, Louisiana, Forenede Stater
- 511.84.01025 Boehringer Ingelheim Investigational Site
-
Lafayette, Louisiana, Forenede Stater
- 511.84.01171 Boehringer Ingelheim Investigational Site
-
New Orlean, Louisiana, Forenede Stater
- 511.84.01130 Boehringer Ingelheim Investigational Site
-
New Orleans, Louisiana, Forenede Stater
- 511.84.01192 Boehringer Ingelheim Investigational Site
-
-
Maryland
-
Baltimore, Maryland, Forenede Stater
- 511.84.01001 Boehringer Ingelheim Investigational Site
-
-
Massachusetts
-
Brighton, Massachusetts, Forenede Stater
- 511.84.01120 Boehringer Ingelheim Investigational Site
-
Haverhill, Massachusetts, Forenede Stater
- 511.84.01030 Boehringer Ingelheim Investigational Site
-
-
Michigan
-
Ann Arbor, Michigan, Forenede Stater
- 511.84.01127 Boehringer Ingelheim Investigational Site
-
Bingham Farms, Michigan, Forenede Stater
- 511.84.01081 Boehringer Ingelheim Investigational Site
-
Bingham Farms, Michigan, Forenede Stater
- 511.84.01147 Boehringer Ingelheim Investigational Site
-
Detroit, Michigan, Forenede Stater
- 511.84.01041 Boehringer Ingelheim Investigational Site
-
-
Minnesota
-
Chaska, Minnesota, Forenede Stater
- 511.84.01131 Boehringer Ingelheim Investigational Site
-
-
Missouri
-
Chesterfield, Missouri, Forenede Stater
- 511.84.01128 Boehringer Ingelheim Investigational Site
-
Kansas City, Missouri, Forenede Stater
- 511.84.01051 Boehringer Ingelheim Investigational Site
-
St. Louis, Missouri, Forenede Stater
- 511.84.01034 Boehringer Ingelheim Investigational Site
-
-
Montana
-
Billings, Montana, Forenede Stater
- 511.84.01042 Boehringer Ingelheim Investigational Site
-
-
Nebraska
-
Omaha, Nebraska, Forenede Stater
- 511.84.01156 Boehringer Ingelheim Investigational Site
-
-
Nevada
-
Las Vegas, Nevada, Forenede Stater
- 511.84.01148 Boehringer Ingelheim Investigational Site
-
-
New Jersey
-
Moorestown, New Jersey, Forenede Stater
- 511.84.01206 Boehringer Ingelheim Investigational Site
-
New Brunswick, New Jersey, Forenede Stater
- 511.84.01010 Boehringer Ingelheim Investigational Site
-
-
New Mexico
-
Albequerque, New Mexico, Forenede Stater
- 511.84.01045 Boehringer Ingelheim Investigational Site
-
-
New York
-
Bronx, New York, Forenede Stater
- 511.84.01059 Boehringer Ingelheim Investigational Site
-
Endwell, New York, Forenede Stater
- 511.84.01050 Boehringer Ingelheim Investigational Site
-
Poughkeepsie, New York, Forenede Stater
- 511.84.01066 Boehringer Ingelheim Investigational Site
-
Purchase, New York, Forenede Stater
- 511.84.01187 Boehringer Ingelheim Investigational Site
-
Rochester, New York, Forenede Stater
- 511.84.01038 Boehringer Ingelheim Investigational Site
-
-
North Carolina
-
Chapel Hill, North Carolina, Forenede Stater
- 511.84.01178 Boehringer Ingelheim Investigational Site
-
New Bern, North Carolina, Forenede Stater
- 511.84.01121 Boehringer Ingelheim Investigational Site
-
Raleigh, North Carolina, Forenede Stater
- 511.84.01119 Boehringer Ingelheim Investigational Site
-
Winston-Salem, North Carolina, Forenede Stater
- 511.84.01072 Boehringer Ingelheim Investigational Site
-
-
Ohio
-
Beachwood, Ohio, Forenede Stater
- 511.84.01106 Boehringer Ingelheim Investigational Site
-
Cincinnati, Ohio, Forenede Stater
- 511.84.01008 Boehringer Ingelheim Investigational Site
-
Cincinnati, Ohio, Forenede Stater
- 511.84.01062 Boehringer Ingelheim Investigational Site
-
Cincinnati, Ohio, Forenede Stater
- 511.84.01089 Boehringer Ingelheim Investigational Site
-
Cincinnati, Ohio, Forenede Stater
- 511.84.01197 Boehringer Ingelheim Investigational Site
-
Cincinnati, Ohio, Forenede Stater
- 511.84.01201 Boehringer Ingelheim Investigational Site
-
Cleveland, Ohio, Forenede Stater
- 511.84.01009 Boehringer Ingelheim Investigational Site
-
Cleveland, Ohio, Forenede Stater
- 511.84.01014 Boehringer Ingelheim Investigational Site
-
Cleveland, Ohio, Forenede Stater
- 511.84.01152 Boehringer Ingelheim Investigational Site
-
Columbus, Ohio, Forenede Stater
- 511.84.01136 Boehringer Ingelheim Investigational Site
-
Columbus, Ohio, Forenede Stater
- 511.84.01149 Boehringer Ingelheim Investigational Site
-
Columbus, Ohio, Forenede Stater
- 511.84.01151 Boehringer Ingelheim Investigational Site
-
Dayton, Ohio, Forenede Stater
- 511.84.01150 Boehringer Ingelheim Investigational Site
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Forenede Stater
- 511.84.01190 Boehringer Ingelheim Investigational Site
-
Tulsa, Oklahoma, Forenede Stater
- 511.84.01112 Planned Parenthood of Arkansas & Estrn Oklahoma, Inc
-
Tulsa, Oklahoma, Forenede Stater
- 511.84.01185 Boehringer Ingelheim Investigational Site
-
-
Oregon
-
Eugene, Oregon, Forenede Stater
- 511.84.01019 Boehringer Ingelheim Investigational Site
-
Medfod, Oregon, Forenede Stater
- 511.84.01134 Boehringer Ingelheim Investigational Site
-
Portland, Oregon, Forenede Stater
- 511.84.01103 Boehringer Ingelheim Investigational Site
-
-
Pennsylvania
-
Jenkintown, Pennsylvania, Forenede Stater
- 511.84.01088 Boehringer Ingelheim Investigational Site
-
Philadelphia, Pennsylvania, Forenede Stater
- 511.84.01067 Boehringer Ingelheim Investigational Site
-
Philadelphia, Pennsylvania, Forenede Stater
- 511.84.01153 Boehringer Ingelheim Investigational Site
-
Pittsburgh, Pennsylvania, Forenede Stater
- 511.84.01145 Boehringer Ingelheim Investigational Site
-
West Reading, Pennsylvania, Forenede Stater
- 511.84.01054 Boehringer Ingelheim Investigational Site
-
Wilkes-Barre, Pennsylvania, Forenede Stater
- 511.84.01021 Boehringer Ingelheim Investigational Site
-
-
Rhode Island
-
Warwick, Rhode Island, Forenede Stater
- 511.84.01060 Boehringer Ingelheim Investigational Site
-
-
South Carolina
-
Anderson, South Carolina, Forenede Stater
- 511.84.01063 Boehringer Ingelheim Investigational Site
-
Columbia, South Carolina, Forenede Stater
- 511.84.01124 Boehringer Ingelheim Investigational Site
-
Greenville, South Carolina, Forenede Stater
- 511.84.01123 Boehringer Ingelheim Investigational Site
-
Mt. Pleasant, South Carolina, Forenede Stater
- 511.84.01109 Boehringer Ingelheim Investigational Site
-
-
Tennessee
-
Germantown, Tennessee, Forenede Stater
- 511.84.01174 Boehringer Ingelheim Investigational Site
-
Knoxville, Tennessee, Forenede Stater
- 511.84.01163 Boehringer Ingelheim Investigational Site
-
Nashville, Tennessee, Forenede Stater
- 511.84.01026 Boehringer Ingelheim Investigational Site
-
Nashville, Tennessee, Forenede Stater
- 511.84.01100 Boehringer Ingelheim Investigational Site
-
-
Texas
-
Austin, Texas, Forenede Stater
- 511.84.01078 Boehringer Ingelheim Investigational Site
-
Corpus Christi, Texas, Forenede Stater
- 511.84.01052 Boehringer Ingelheim Investigational Site
-
Dallas, Texas, Forenede Stater
- 511.84.01027 Boehringer Ingelheim Investigational Site
-
Dallas, Texas, Forenede Stater
- 511.84.01140 Boehringer Ingelheim Investigational Site
-
Fort Worth, Texas, Forenede Stater
- 511.84.01084 Boehringer Ingelheim Investigational Site
-
Houston, Texas, Forenede Stater
- 511.84.01057 Boehringer Ingelheim Investigational Site
-
Houston, Texas, Forenede Stater
- 511.84.01082 Boehringer Ingelheim Investigational Site
-
Houston, Texas, Forenede Stater
- 511.84.01198 Boehringer Ingelheim Investigational Site
-
San Antonio, Texas, Forenede Stater
- 511.84.01036 Boehringer Ingelheim Investigational Site
-
San Antonio, Texas, Forenede Stater
- 511.84.01071 Boehringer Ingelheim Investigational Site
-
San Antonio, Texas, Forenede Stater
- 511.84.01083 Boehringer Ingelheim Investigational Site
-
San Antonio, Texas, Forenede Stater
- 511.84.01086 Boehringer Ingelheim Investigational Site
-
Waco, Texas, Forenede Stater
- 511.84.01098 Boehringer Ingelheim Investigational Site
-
-
Utah
-
Salt Lake City, Utah, Forenede Stater
- 511.84.01015 Boehringer Ingelheim Investigational Site
-
Sandy, Utah, Forenede Stater
- 511.84.01180 Boehringer Ingelheim Investigational Site
-
-
Vermont
-
Burlington, Vermont, Forenede Stater
- 511.84.01028 Boehringer Ingelheim Investigational Site
-
-
Virginia
-
Charlottesville, Virginia, Forenede Stater
- 511.84.01031 Boehringer Ingelheim Investigational Site
-
Charlottesville, Virginia, Forenede Stater
- 511.84.01035 Boehringer Ingelheim Investigational Site
-
Norfolk, Virginia, Forenede Stater
- 511.84.01107 Boehringer Ingelheim Investigational Site
-
Norfolk, Virginia, Forenede Stater
- 511.84.01125 Boehringer Ingelheim Investigational Site
-
Richmond, Virginia, Forenede Stater
- 511.84.01076 Boehringer Ingelheim Investigational Site
-
Richmond, Virginia, Forenede Stater
- 511.84.01097 Boehringer Ingelheim Investigational Site
-
Richmond, Virginia, Forenede Stater
- 511.84.01196 Boehringer Ingelheim Investigational Site
-
-
Washington
-
Bellevue, Washington, Forenede Stater
- 511.84.01093 Boehringer Ingelheim Investigational Site
-
Renton, Washington, Forenede Stater
- 511.84.01141 Boehringer Ingelheim Investigational Site
-
Seattle, Washington, Forenede Stater
- 511.84.01012 Boehringer Ingelheim Investigational Site
-
Spokane, Washington, Forenede Stater
- 511.84.01116 Boehringer Ingelheim Investigational Site
-
Tacoma, Washington, Forenede Stater
- 511.84.01105 Boehringer Ingelheim Investigational Site
-
-
Wisconsin
-
Middleton, Wisconsin, Forenede Stater
- 511.84.01177 Boehringer Ingelheim Investigational Site
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 55 år (VOKSEN)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inklusionskriterier:
- Kvinder med en primær diagnose af HSDD, som har gennemført en tidligere undersøgelse af Flibanserin.
- Patienter skal have brugt en medicinsk acceptabel præventionsmetode i mindst 2 måneder før undersøgelsens start og fortsætte med at bruge denne metode i hele undersøgelsens varighed.
- Patienter skal være pålidelige, imødekommende og indvillige i at samarbejde med alle undersøgelsesevalueringer.
- Patienter skal være i stand til og villige til at give meningsfuldt, skriftligt informeret samtykke forud for undersøgelsens start og være villige til at diskutere deres seksuelle funktionsmåde med undersøgelsens personale.
Ekskluderingskriterier:
- En historie med svær depressiv lidelse inden for 6 måneder før starten af undersøgelsen, aktuelle selvmordstanker eller enhver historie med et selvmordsforsøg.
- Deltagelse i et andet klinisk forsøg inden for 1 måned før studiets start, undtagen Flibanserin.
- Patienter med bækkenbetændelse, urinvejsinfektion, vaginal infektion/vaginitis, cervicitis, interstitiel blærebetændelse, vulvodyni eller betydelig vaginal atrofi.
- Patienter, der er gravide eller har været gravide inden for 1 måned før studiestart.
- Patienter, der oplever stor livsstress (inklusive tab af indkomst, et familiemedlems død, større sygdom osv.) eller problemer i forholdet, der kunne forstyrre seksuel aktivitet, undtagen angst omkring HSDD.
- Klinisk signifikante EKG- eller laboratorieabnormiteter ved studiestart.
- Patienter, der tager forbudte medicin, som var udelukket i deres tidligere forsøg, som bidrager til seksuel dysfunktion eller sikkerhedsrelaterede interaktioner.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: BEHANDLING
- Tildeling: NA
- Interventionel model: SINGLE_GROUP
- Maskning: INGEN
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
EKSPERIMENTEL: flibanserin
fleksibel dosering på enten 50 eller 100 mg hver aften eller 25 eller 50 mg to gange dagligt.
|
fleksibel dosering på enten 50 eller 100 mg hver aften eller 25 eller 50 mg to gange dagligt.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Hyppigheden af uønskede hændelser (bivirkninger).
Tidsramme: 52 uger
|
Dette er et 52-ugers, åbent forsøg, der vurderer sikkerhed/tolerabilitet af flibanserin hos kvinder med hypoaktiv seksuel lystsforstyrrelse
|
52 uger
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2007
Primær færdiggørelse (FAKTISKE)
1. august 2009
Studieafslutning (FAKTISKE)
1. august 2009
Datoer for studieregistrering
Først indsendt
28. februar 2007
Først indsendt, der opfyldte QC-kriterier
28. februar 2007
Først opslået (SKØN)
1. marts 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (SKØN)
13. juni 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. maj 2014
Sidst verificeret
1. maj 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 511.84
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Seksuelle dysfunktioner, psykologiske
-
Stimdia Medical, Inc.AfsluttetVentilator-induceret diaphragmatic dysfunction (VIDD)Irland, Tjekkiet
-
Nationwide Children's HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development...RekrutteringPædiatrisk Sepsis-induceret Multiple Organ Dysfunction SyndromeForenede Stater
-
University of WaterlooAfsluttetMeibomian Gland Dysfunction (MGD)Canada
-
Nationwide Children's HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development...RekrutteringPædiatrisk Sepsis-induceret Multiple Organ Dysfunction Syndrome (MODS)Forenede Stater
-
Singapore National Eye CentreNational University, SingaporeAfsluttet
-
Grand Valley State UniversityTilmelding efter invitationMetabolic Associated-dysfunction Steatotic Lever Disease (MASLD) | Metabolic Associated-dysfunction Steatohepatitis (MASH)Forenede Stater
-
Johnson & Johnson Surgical Vision, Inc.AfsluttetGrå stær | Meibomian Gland Dysfunction (MGD)Forenede Stater
-
Azura OphthalmicsThe University of New South WalesAfsluttetMeibomian Gland Dysfunction (MGD) | Kontaktlinsebesvær (CLD)Australien
-
Ivix LLXAfsluttetHypoactive Sexual Desire Disorder (HSDD)Den Russiske Føderation
-
Advanced Perfusion DiagnosticsCEISOAfsluttetMultiple Organ Dysfunction SyndromeFrankrig
Kliniske forsøg med Flibanserin
-
Sprout Pharmaceuticals, IncAfsluttetSeksuelle dysfunktioner, psykologiskeForenede Stater, Canada
-
Sprout Pharmaceuticals, IncAfsluttetSeksuelle dysfunktioner, psykologiskeForenede Stater, Canada
-
Sprout Pharmaceuticals, IncAfsluttetSeksuelle dysfunktioner, psykologiskeForenede Stater, Canada
-
Sprout Pharmaceuticals, IncAfsluttetSeksuelle dysfunktioner, psykologiskeForenede Stater, Canada
-
Mohit KheraSprout Pharmaceuticals, IncRekruttering
-
Sprout Pharmaceuticals, IncAfsluttetSeksuelle dysfunktioner, psykologiskeForenede Stater, Canada
-
Sprout Pharmaceuticals, IncAfsluttetSeksuelle dysfunktioner, psykologiskeØstrig, Belgien, Tjekkiet, Finland, Frankrig, Tyskland, Ungarn, Italien, Holland, Spanien, Sverige, Det Forenede Kongerige
-
Genuine Research Center, EgyptBio Med for Pharmaceuticals Industries (BIOMED), EgyptAfsluttet
-
Sprout Pharmaceuticals, IncAfsluttetSeksuelle dysfunktioner, psykologiskeForenede Stater
-
Sprout Pharmaceuticals, IncAfsluttetSeksuelle dysfunktioner, psykologiskeForenede Stater