A One-year Safety Study of Flibanserin to Treat Pre-Menopausal Women With Hypoactive Sexual Desire Disorder (HSDD).
- 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
- Women with a primary diagnosis of HSDD who have completed a previous study of Flibanserin.
- 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.
- Patients must be reliable, compliant, and agree to cooperate with all study evaluations.
- 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.
- 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.
- Participation in another clinical trial within 1 month prior to the start of the study, except for Flibanserin.
- Patients with pelvic inflammatory disease, urinary tract infection, vaginal infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant vaginal atrophy.
- Patients who are pregnant or have been pregnant within 1 month prior to study start.
- 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.
- Clinically significant ECG or lab abnormalities at study start.
- Patients taking prohibited medications that were excluded in their previous trial which contribute to sexual dysfunction or safety-related interactions.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description flibanserin Flibanserin flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
- Primary Outcome Measures
Name Time Method 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
Name Time Method
Trial Locations
- Locations (196)
511.84.02015 Boehringer Ingelheim Investigational Site
๐จ๐ฆVictoria, British Columbia, Canada
511.84.01198 Boehringer Ingelheim Investigational Site
๐บ๐ธHouston, Texas, United States
511.84.01012 Boehringer Ingelheim Investigational Site
๐บ๐ธSeattle, Washington, United States
511.84.01055 Boehringer Ingelheim Investigational Site
๐บ๐ธMiami, Florida, United States
511.84.01092 Boehringer Ingelheim Investigational Site
๐บ๐ธIndianapolis, Indiana, United States
511.84.01148 Boehringer Ingelheim Investigational Site
๐บ๐ธLas Vegas, Nevada, United States
511.84.01062 Boehringer Ingelheim Investigational Site
๐บ๐ธCincinnati, Ohio, United States
511.84.01197 Boehringer Ingelheim Investigational Site
๐บ๐ธCincinnati, Ohio, United States
511.84.01043 Boehringer Ingelheim Investigational Site
๐บ๐ธSan Diego, California, United States
511.84.01157 Boehringer Ingelheim Investigational Site
๐บ๐ธMobile, Alabama, United States
511.84.01048 Boehringer Ingelheim Investigational Site
๐บ๐ธTarzana, California, United States
511.84.01142 Boehringer Ingelheim Investigational Site
๐บ๐ธMobile, Alabama, United States
511.84.01052 Boehringer Ingelheim Investigational Site
๐บ๐ธCorpus Christi, Texas, United States
511.84.01107 Boehringer Ingelheim Investigational Site
๐บ๐ธNorfolk, Virginia, United States
511.84.01093 Boehringer Ingelheim Investigational Site
๐บ๐ธBellevue, Washington, United States
511.84.01131 Boehringer Ingelheim Investigational Site
๐บ๐ธChaska, Minnesota, United States
511.84.01188 Boehringer Ingelheim Investigational Site
๐บ๐ธHuntsville, Alabama, United States
511.84.01162 Boehringer Ingelheim Investigational Site
๐บ๐ธLittle Rock, Alaska, United States
511.84.01006 Boehringer Ingelheim Investigational Site
๐บ๐ธWheatridge, Colorado, United States
511.84.01004 Boehringer Ingelheim Investigational Site
๐บ๐ธEnglewood, Colorado, United States
511.84.01110 Boehringer Ingelheim Investigational Site
๐บ๐ธMobile, Alabama, United States
511.84.01029 Boehringer Ingelheim Investigational Site
๐บ๐ธWalnut Creek, California, United States
511.84.01047 Boehringer Ingelheim Investigational Site
๐บ๐ธSan Diego, California, United States
511.84.01040 Boehringer Ingelheim Investigational Site
๐บ๐ธStanford, California, United States
511.84.01173 Boehringer Ingelheim Investigational Site
๐บ๐ธVista, California, United States
511.84.01137 Boehringer Ingelheim Investigational Site
๐บ๐ธWestlake Village, California, United States
511.84.01087 Boehringer Ingelheim Investigational Site
๐บ๐ธBerkeley, California, United States
511.84.01176 Boehringer Ingelheim Investigational Site
๐บ๐ธMarietta, Georgia, United States
511.84.01037 Boehringer Ingelheim Investigational Site
๐บ๐ธLa Jolla, California, United States
511.84.01017 Boehringer Ingelheim Investigational Site
๐บ๐ธTorrance, California, United States
511.84.01077 Boehringer Ingelheim Investigational Site
๐บ๐ธEncinitas, California, United States
511.84.01104 Boehringer Ingelheim Investigational Site
๐บ๐ธIrvine, California, United States
511.84.01096 Boehringer Ingelheim Investigational Site
๐บ๐ธSan Diego, California, United States
511.84.01074 Boehringer Ingelheim Investigational Site
๐บ๐ธFair Oaks, California, United States
511.84.01023 Boehringer Ingelheim Investigational Site
๐บ๐ธSandy Springs, Georgia, United States
511.84.01061 Boehringer Ingelheim Investigational Site
๐บ๐ธAtlanta, Georgia, United States
511.84.01179 Boehringer Ingelheim Investigational Site
๐บ๐ธChampaign, Illinois, United States
511.84.01106 Boehringer Ingelheim Investigational Site
๐บ๐ธBeachwood, Ohio, United States
511.84.01139 Boehringer Ingelheim Investigational Site
๐บ๐ธRoswell, Georgia, United States
511.84.01066 Boehringer Ingelheim Investigational Site
๐บ๐ธPoughkeepsie, New York, United States
511.84.01034 Boehringer Ingelheim Investigational Site
๐บ๐ธSt. Louis, Missouri, United States
511.84.01205 Boehringer Ingelheim Investigational Site
๐บ๐ธAtlanta, Georgia, United States
511.84.01113 Boehringer Ingelheim Investigational Site
๐บ๐ธChicago, Illinois, United States
511.84.01172 Boehringer Ingelheim Investigational Site
๐บ๐ธChicago, Illinois, United States
511.84.01121 Boehringer Ingelheim Investigational Site
๐บ๐ธNew Bern, North Carolina, United States
511.84.01050 Boehringer Ingelheim Investigational Site
๐บ๐ธEndwell, New York, United States
511.84.01151 Boehringer Ingelheim Investigational Site
๐บ๐ธColumbus, Ohio, United States
511.84.01145 Boehringer Ingelheim Investigational Site
๐บ๐ธPittsburgh, Pennsylvania, United States
511.84.01089 Boehringer Ingelheim Investigational Site
๐บ๐ธCincinnati, Ohio, United States
511.84.01201 Boehringer Ingelheim Investigational Site
๐บ๐ธCincinnati, Ohio, United States
511.84.01021 Boehringer Ingelheim Investigational Site
๐บ๐ธWilkes-Barre, Pennsylvania, United States
511.84.01119 Boehringer Ingelheim Investigational Site
๐บ๐ธRaleigh, North Carolina, United States
511.84.01054 Boehringer Ingelheim Investigational Site
๐บ๐ธWest Reading, Pennsylvania, United States
511.84.01088 Boehringer Ingelheim Investigational Site
๐บ๐ธJenkintown, Pennsylvania, United States
511.84.01136 Boehringer Ingelheim Investigational Site
๐บ๐ธColumbus, Ohio, United States
511.84.01149 Boehringer Ingelheim Investigational Site
๐บ๐ธColumbus, Ohio, United States
511.84.01185 Boehringer Ingelheim Investigational Site
๐บ๐ธTulsa, Oklahoma, United States
511.84.01067 Boehringer Ingelheim Investigational Site
๐บ๐ธPhiladelphia, Pennsylvania, United States
511.84.01153 Boehringer Ingelheim Investigational Site
๐บ๐ธPhiladelphia, Pennsylvania, United States
511.84.01014 Boehringer Ingelheim Investigational Site
๐บ๐ธCleveland, Ohio, United States
511.84.01112 Planned Parenthood of Arkansas & Estrn Oklahoma, Inc
๐บ๐ธTulsa, Oklahoma, United States
511.84.02017 Boehringer Ingelheim Investigational Site
๐จ๐ฆWinnipeg, Manitoba, Canada
511.84.01079 Boehringer Ingelheim Investigational Site
๐บ๐ธBirmingham, Alabama, United States
511.84.01191 Boehringer Ingelheim Investigational Site
๐บ๐ธPhoenix, Arizona, United States
511.84.01190 Boehringer Ingelheim Investigational Site
๐บ๐ธOklahoma City, Oklahoma, United States
511.84.01193 Boehringer Ingelheim Investigational Site
๐บ๐ธBirmingham, Alabama, United States
511.84.01070 Boehringer Ingelheim Investigational Site
๐บ๐ธPhoenix, Arizona, United States
511.84.01041 Boehringer Ingelheim Investigational Site
๐บ๐ธDetroit, Michigan, United States
511.84.01103 Boehringer Ingelheim Investigational Site
๐บ๐ธPortland, Oregon, United States
511.84.01026 Boehringer Ingelheim Investigational Site
๐บ๐ธNashville, Tennessee, United States
511.84.01015 Boehringer Ingelheim Investigational Site
๐บ๐ธSalt Lake City, Utah, United States
511.84.01071 Boehringer Ingelheim Investigational Site
๐บ๐ธSan Antonio, Texas, United States
511.84.01083 Boehringer Ingelheim Investigational Site
๐บ๐ธSan Antonio, Texas, United States
511.84.01086 Boehringer Ingelheim Investigational Site
๐บ๐ธSan Antonio, Texas, United States
511.84.01164 Boehringer Ingelheim Investigational Site
๐บ๐ธDenver, Colorado, United States
511.84.01184 Boehringer Ingelheim Investigational Site
๐บ๐ธDenver, Colorado, United States
511.84.01100 Boehringer Ingelheim Investigational Site
๐บ๐ธNashville, Tennessee, United States
511.84.01069 Boehringer Ingelheim Investigational Site
๐บ๐ธGainsville, Florida, United States
511.84.01159 Boehringer Ingelheim Investigational Site
๐บ๐ธTampa, Florida, United States
511.84.01170 Boehringer Ingelheim Investigational Site
๐บ๐ธTampa, Florida, United States
511.84.01183 Boehringer Ingelheim Investigational Site
๐บ๐ธTampa, Florida, United States
511.84.01090 Boehringer Ingelheim Investigational Site
๐บ๐ธAurora, Colorado, United States
511.84.01108 Boehringer Ingelheim Investigational Site
๐บ๐ธNew Britain, Connecticut, United States
511.84.01169 Boehringer Ingelheim Investigational Site
๐บ๐ธDaytona Beach, Florida, United States
511.84.01182 Boehringer Ingelheim Investigational Site
๐บ๐ธNew Port Richey, Florida, United States
511.84.01175 Boehringer Ingelheim Investigational Site
๐บ๐ธSarasota, Florida, United States
511.84.01032 Boehringer Ingelheim Investigational Site
๐บ๐ธPlantation, Florida, United States
511.84.01022 Boehringer Ingelheim Investigational Site
๐บ๐ธWest Palm Beach, Florida, United States
511.84.01024 Boehringer Ingelheim Investigational Site
๐บ๐ธAtlanta, Georgia, United States
511.84.01165 Boehringer Ingelheim Investigational Site
๐บ๐ธChicago, Illinois, United States
511.84.01120 Boehringer Ingelheim Investigational Site
๐บ๐ธBrighton, Massachusetts, United States
511.84.01128 Boehringer Ingelheim Investigational Site
๐บ๐ธChesterfield, Missouri, United States
511.84.01081 Boehringer Ingelheim Investigational Site
๐บ๐ธBingham Farms, Michigan, United States
511.84.01030 Boehringer Ingelheim Investigational Site
๐บ๐ธHaverhill, Massachusetts, United States
511.84.01045 Boehringer Ingelheim Investigational Site
๐บ๐ธAlbequerque, New Mexico, United States
511.84.01187 Boehringer Ingelheim Investigational Site
๐บ๐ธPurchase, New York, United States
511.84.01008 Boehringer Ingelheim Investigational Site
๐บ๐ธCincinnati, Ohio, United States
511.84.01009 Boehringer Ingelheim Investigational Site
๐บ๐ธCleveland, Ohio, United States
511.84.01152 Boehringer Ingelheim Investigational Site
๐บ๐ธCleveland, Ohio, United States
511.84.01060 Boehringer Ingelheim Investigational Site
๐บ๐ธWarwick, Rhode Island, United States
511.84.01063 Boehringer Ingelheim Investigational Site
๐บ๐ธAnderson, South Carolina, United States
511.84.01124 Boehringer Ingelheim Investigational Site
๐บ๐ธColumbia, South Carolina, United States
511.84.01123 Boehringer Ingelheim Investigational Site
๐บ๐ธGreenville, South Carolina, United States
511.84.01163 Boehringer Ingelheim Investigational Site
๐บ๐ธKnoxville, Tennessee, United States
511.84.01174 Boehringer Ingelheim Investigational Site
๐บ๐ธGermantown, Tennessee, United States
511.84.01027 Boehringer Ingelheim Investigational Site
๐บ๐ธDallas, Texas, United States
511.84.01140 Boehringer Ingelheim Investigational Site
๐บ๐ธDallas, Texas, United States
511.84.01057 Boehringer Ingelheim Investigational Site
๐บ๐ธHouston, Texas, United States
511.84.01084 Boehringer Ingelheim Investigational Site
๐บ๐ธFort Worth, Texas, United States
511.84.01036 Boehringer Ingelheim Investigational Site
๐บ๐ธSan Antonio, Texas, United States
511.84.01082 Boehringer Ingelheim Investigational Site
๐บ๐ธHouston, Texas, United States
511.84.01098 Boehringer Ingelheim Investigational Site
๐บ๐ธWaco, Texas, United States
511.84.01180 Boehringer Ingelheim Investigational Site
๐บ๐ธSandy, Utah, United States
511.84.01031 Boehringer Ingelheim Investigational Site
๐บ๐ธCharlottesville, Virginia, United States
511.84.01028 Boehringer Ingelheim Investigational Site
๐บ๐ธBurlington, Vermont, United States
511.84.01035 Boehringer Ingelheim Investigational Site
๐บ๐ธCharlottesville, Virginia, United States
511.84.01125 Boehringer Ingelheim Investigational Site
๐บ๐ธNorfolk, Virginia, United States
511.84.01116 Boehringer Ingelheim Investigational Site
๐บ๐ธSpokane, Washington, United States
511.84.01141 Boehringer Ingelheim Investigational Site
๐บ๐ธRenton, Washington, United States
511.84.01105 Boehringer Ingelheim Investigational Site
๐บ๐ธTacoma, Washington, United States
511.84.01177 Boehringer Ingelheim Investigational Site
๐บ๐ธMiddleton, Wisconsin, United States
511.84.02014 Boehringer Ingelheim Investigational Site
๐จ๐ฆCoquitlam, British Columbia, Canada
511.84.02002 Boehringer Ingelheim Investigational Site
๐จ๐ฆNorth Vancouver, British Columbia, Canada
511.84.01013 Boehringer Ingelheim Investigational Site
๐บ๐ธJonesboro, Arkansas, United States
511.84.01016 Boehringer Ingelheim Investigational Site
๐บ๐ธHartford, Connecticut, United States
511.84.01085 Boehringer Ingelheim Investigational Site
๐บ๐ธFort Lauderdale, Florida, United States
511.84.01144 Boehringer Ingelheim Investigational Site
๐บ๐ธCoral Gables, Florida, United States
511.84.01146 Boehringer Ingelheim Investigational Site
๐บ๐ธClearwater, Florida, United States
511.84.01194 Boehringer Ingelheim Investigational Site
๐บ๐ธFort Meyers, Florida, United States
511.84.01138 Boehringer Ingelheim Investigational Site
๐บ๐ธFarmington, Connecticut, United States
511.84.01065 Boehringer Ingelheim Investigational Site
๐บ๐ธAventura, Florida, United States
511.84.01115 Boehringer Ingelheim Investigational Site
๐บ๐ธTucson, Arizona, United States
511.84.01156 Boehringer Ingelheim Investigational Site
๐บ๐ธOmaha, Nebraska, United States
511.84.01044 Boehringer Ingelheim Investigational Site
๐บ๐ธGroton, Connecticut, United States
511.84.01171 Boehringer Ingelheim Investigational Site
๐บ๐ธLafayette, Louisiana, United States
511.84.01025 Boehringer Ingelheim Investigational Site
๐บ๐ธBaton Rouge, Louisiana, United States
511.84.01135 Boehringer Ingelheim Investigational Site
๐บ๐ธPembroke Pines, Florida, United States
511.84.01160 Boehringer Ingelheim Investigational Site
๐บ๐ธWashington, District of Columbia, United States
511.84.01064 Boehringer Ingelheim Investigational Site
๐บ๐ธMiami, Florida, United States
511.84.02020 Boehringer Ingelheim Investigational Site
๐จ๐ฆQuebec, Canada
511.84.01166 Boehringer Ingelheim Investigational Site
๐บ๐ธNewark, Delaware, United States
511.84.01109 Boehringer Ingelheim Investigational Site
๐บ๐ธMt. Pleasant, South Carolina, United States
511.84.02005 Boehringer Ingelheim Investigational Site
๐จ๐ฆSherbrooke, Quebec, Canada
511.84.01053 Boehringer Ingelheim Investigational Site
๐บ๐ธSt. Petersburg, Florida, United States
511.84.01132 Boehringer Ingelheim Investigational Site
๐บ๐ธSt. Petersburg, Florida, United States
511.84.01206 Boehringer Ingelheim Investigational Site
๐บ๐ธMoorestown, New Jersey, United States
511.84.01117 Boehringer Ingelheim Investigational Site
๐บ๐ธStuart, Florida, United States
511.84.01005 Boehringer Ingelheim Investigational Site
๐บ๐ธBoynton Beach, Florida, United States
511.84.01007 Boehringer Ingelheim Investigational Site
๐บ๐ธHudson, Florida, United States
511.84.01167 Boehringer Ingelheim Investigational Site
๐บ๐ธOcala, Florida, United States
511.84.01168 Boehringer Ingelheim Investigational Site
๐บ๐ธNew London, Connecticut, United States
511.84.01147 Boehringer Ingelheim Investigational Site
๐บ๐ธBingham Farms, Michigan, United States
511.84.02010 Boehringer Ingelheim Investigational Site
๐จ๐ฆWoodstock, New Brunswick, Canada
511.84.02011 Boehringer Ingelheim Investigational Site
๐จ๐ฆMontrรฉal, Quebec, Canada
511.84.02019 Boehringer Ingelheim Investigational Site
๐จ๐ฆQuรฉbec, Quebec, Canada
511.84.02023 Boehringer Ingelheim Investigational Site
๐จ๐ฆVictoria, British Columbia, Canada
511.84.02003 Boehringer Ingelheim Investigational Site
๐จ๐ฆHalifax, Nova Scotia, Canada
511.84.01003 Boehringer Ingelheim Investigational Site
๐บ๐ธWest Palm Beach, Florida, United States
511.84.01042 Boehringer Ingelheim Investigational Site
๐บ๐ธBillings, Montana, United States
511.84.02022 Boehringer Ingelheim Investigational Site
๐จ๐ฆLondon, Ontario, Canada
511.84.02024 Boehringer Ingelheim Investigational Site
๐จ๐ฆLondon, Ontario, Canada
511.84.02008 Boehringer Ingelheim Investigational Site
๐จ๐ฆOttawa, Ontario, Canada
511.84.02012 Boehringer Ingelheim Investigational Site
๐จ๐ฆMount Pearl, Newfoundland and Labrador, Canada
511.84.01130 Boehringer Ingelheim Investigational Site
๐บ๐ธNew Orlean, Louisiana, United States
511.84.01001 Boehringer Ingelheim Investigational Site
๐บ๐ธBaltimore, Maryland, United States
511.84.02013 Boehringer Ingelheim Investigational Site
๐จ๐ฆVancouver, British Columbia, Canada
511.84.02021 Boehringer Ingelheim Investigational Site
๐จ๐ฆSurrey, British Columbia, Canada
511.84.02004 Boehringer Ingelheim Investigational Site
๐จ๐ฆSaskatoon, Saskatchewan, Canada
511.84.02009 Boehringer Ingelheim Investigational Site
๐จ๐ฆBurlington, Ontario, Canada
511.84.01134 Boehringer Ingelheim Investigational Site
๐บ๐ธMedfod, Oregon, United States
511.84.01010 Boehringer Ingelheim Investigational Site
๐บ๐ธNew Brunswick, New Jersey, United States
511.84.02007 Boehringer Ingelheim Investigational Site
๐จ๐ฆCalgary, Alberta, Canada
511.84.01019 Boehringer Ingelheim Investigational Site
๐บ๐ธEugene, Oregon, United States
511.84.02018 Boehringer Ingelheim Investigational Site
๐จ๐ฆBarrie, Ontario, Canada
511.84.01056 Boehringer Ingelheim Investigational Site
๐บ๐ธSacramento, California, United States
511.84.01127 Boehringer Ingelheim Investigational Site
๐บ๐ธAnn Arbor, Michigan, United States
511.84.01195 Boehringer Ingelheim Investigational Site
๐บ๐ธSacramento, California, United States
511.84.01072 Boehringer Ingelheim Investigational Site
๐บ๐ธWinston-Salem, North Carolina, United States
511.84.01111 Boehringer Ingelheim Investigational Site
๐บ๐ธOrlando, Florida, United States
511.84.01118 Boehringer Ingelheim Investigational Site
๐บ๐ธOrlando, Florida, United States
511.84.01192 Boehringer Ingelheim Investigational Site
๐บ๐ธNew Orleans, Louisiana, United States
511.84.01051 Boehringer Ingelheim Investigational Site
๐บ๐ธKansas City, Missouri, United States
511.84.01178 Boehringer Ingelheim Investigational Site
๐บ๐ธChapel Hill, North Carolina, United States
511.84.01078 Boehringer Ingelheim Investigational Site
๐บ๐ธAustin, Texas, United States
511.84.01076 Boehringer Ingelheim Investigational Site
๐บ๐ธRichmond, Virginia, United States
511.84.01097 Boehringer Ingelheim Investigational Site
๐บ๐ธRichmond, Virginia, United States
511.84.01196 Boehringer Ingelheim Investigational Site
๐บ๐ธRichmond, Virginia, United States
511.84.01002 Boehringer Ingelheim Investigational Site
๐บ๐ธGainesville, Florida, United States
511.84.01202 Boehringer Ingelheim Investigational Site
๐บ๐ธWichita, Kansas, United States
511.84.01049 Boehringer Ingelheim Investigational Site
๐บ๐ธLexington, Kentucky, United States
511.84.01059 Boehringer Ingelheim Investigational Site
๐บ๐ธBronx, New York, United States
511.84.01038 Boehringer Ingelheim Investigational Site
๐บ๐ธRochester, New York, United States
511.84.01150 Boehringer Ingelheim Investigational Site
๐บ๐ธDayton, Ohio, United States
511.84.02001 Boehringer Ingelheim Investigational Site
๐จ๐ฆOttawa, Ontario, Canada
511.84.02006 Boehringer Ingelheim Investigational Site
๐จ๐ฆSt. John's, Newfoundland and Labrador, Canada
511.84.01143 Boehringer Ingelheim Investigational Site
๐บ๐ธEvansville, Indiana, United States