A One-year Safety Study of Flibanserin to Treat Pre-Menopausal Women With Hypoactive Sexual Desire Disorder (HSDD).
Sponsor
Sprout Pharmaceuticals, Inc (Industry)
Overall Status
Terminated
CT.gov ID
NCT00441558
Collaborator
(none)
1,723
196
1
30
8.8
0.3
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
1723 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Worldwide One-year Open-label Safety Study of Flibanserin in Women With HSDD
Study Start Date
:
Feb 1, 2007
Actual Primary Completion Date
:
Aug 1, 2009
Actual Study Completion Date
:
Aug 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: flibanserin flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily. |
Drug: Flibanserin
flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 55 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 511.84.01079 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | United States | |
| 2 | 511.84.01193 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | United States | |
| 3 | 511.84.01188 Boehringer Ingelheim Investigational Site | Huntsville | Alabama | United States | |
| 4 | 511.84.01110 Boehringer Ingelheim Investigational Site | Mobile | Alabama | United States | |
| 5 | 511.84.01142 Boehringer Ingelheim Investigational Site | Mobile | Alabama | United States | |
| 6 | 511.84.01157 Boehringer Ingelheim Investigational Site | Mobile | Alabama | United States | |
| 7 | 511.84.01162 Boehringer Ingelheim Investigational Site | Little Rock | Alaska | United States | |
| 8 | 511.84.01070 Boehringer Ingelheim Investigational Site | Phoenix | Arizona | United States | |
| 9 | 511.84.01191 Boehringer Ingelheim Investigational Site | Phoenix | Arizona | United States | |
| 10 | 511.84.01115 Boehringer Ingelheim Investigational Site | Tucson | Arizona | United States | |
| 11 | 511.84.01013 Boehringer Ingelheim Investigational Site | Jonesboro | Arkansas | United States | |
| 12 | 511.84.01087 Boehringer Ingelheim Investigational Site | Berkeley | California | United States | |
| 13 | 511.84.01077 Boehringer Ingelheim Investigational Site | Encinitas | California | United States | |
| 14 | 511.84.01074 Boehringer Ingelheim Investigational Site | Fair Oaks | California | United States | |
| 15 | 511.84.01104 Boehringer Ingelheim Investigational Site | Irvine | California | United States | |
| 16 | 511.84.01037 Boehringer Ingelheim Investigational Site | La Jolla | California | United States | |
| 17 | 511.84.01056 Boehringer Ingelheim Investigational Site | Sacramento | California | United States | |
| 18 | 511.84.01195 Boehringer Ingelheim Investigational Site | Sacramento | California | United States | |
| 19 | 511.84.01043 Boehringer Ingelheim Investigational Site | San Diego | California | United States | |
| 20 | 511.84.01047 Boehringer Ingelheim Investigational Site | San Diego | California | United States | |
| 21 | 511.84.01096 Boehringer Ingelheim Investigational Site | San Diego | California | United States | |
| 22 | 511.84.01040 Boehringer Ingelheim Investigational Site | Stanford | California | United States | |
| 23 | 511.84.01048 Boehringer Ingelheim Investigational Site | Tarzana | California | United States | |
| 24 | 511.84.01017 Boehringer Ingelheim Investigational Site | Torrance | California | United States | |
| 25 | 511.84.01173 Boehringer Ingelheim Investigational Site | Vista | California | United States | |
| 26 | 511.84.01029 Boehringer Ingelheim Investigational Site | Walnut Creek | California | United States | |
| 27 | 511.84.01137 Boehringer Ingelheim Investigational Site | Westlake Village | California | United States | |
| 28 | 511.84.01090 Boehringer Ingelheim Investigational Site | Aurora | Colorado | United States | |
| 29 | 511.84.01164 Boehringer Ingelheim Investigational Site | Denver | Colorado | United States | |
| 30 | 511.84.01184 Boehringer Ingelheim Investigational Site | Denver | Colorado | United States | |
| 31 | 511.84.01004 Boehringer Ingelheim Investigational Site | Englewood | Colorado | United States | |
| 32 | 511.84.01006 Boehringer Ingelheim Investigational Site | Wheatridge | Colorado | United States | |
| 33 | 511.84.01138 Boehringer Ingelheim Investigational Site | Farmington | Connecticut | United States | |
| 34 | 511.84.01044 Boehringer Ingelheim Investigational Site | Groton | Connecticut | United States | |
| 35 | 511.84.01016 Boehringer Ingelheim Investigational Site | Hartford | Connecticut | United States | |
| 36 | 511.84.01108 Boehringer Ingelheim Investigational Site | New Britain | Connecticut | United States | |
| 37 | 511.84.01168 Boehringer Ingelheim Investigational Site | New London | Connecticut | United States | |
| 38 | 511.84.01166 Boehringer Ingelheim Investigational Site | Newark | Delaware | United States | |
| 39 | 511.84.01160 Boehringer Ingelheim Investigational Site | Washington | District of Columbia | United States | |
| 40 | 511.84.01065 Boehringer Ingelheim Investigational Site | Aventura | Florida | United States | |
| 41 | 511.84.01005 Boehringer Ingelheim Investigational Site | Boynton Beach | Florida | United States | |
| 42 | 511.84.01146 Boehringer Ingelheim Investigational Site | Clearwater | Florida | United States | |
| 43 | 511.84.01144 Boehringer Ingelheim Investigational Site | Coral Gables | Florida | United States | |
| 44 | 511.84.01169 Boehringer Ingelheim Investigational Site | Daytona Beach | Florida | United States | |
| 45 | 511.84.01085 Boehringer Ingelheim Investigational Site | Fort Lauderdale | Florida | United States | |
| 46 | 511.84.01194 Boehringer Ingelheim Investigational Site | Fort Meyers | Florida | United States | |
| 47 | 511.84.01002 Boehringer Ingelheim Investigational Site | Gainesville | Florida | United States | |
| 48 | 511.84.01069 Boehringer Ingelheim Investigational Site | Gainsville | Florida | United States | |
| 49 | 511.84.01007 Boehringer Ingelheim Investigational Site | Hudson | Florida | United States | |
| 50 | 511.84.01055 Boehringer Ingelheim Investigational Site | Miami | Florida | United States | |
| 51 | 511.84.01064 Boehringer Ingelheim Investigational Site | Miami | Florida | United States | |
| 52 | 511.84.01182 Boehringer Ingelheim Investigational Site | New Port Richey | Florida | United States | |
| 53 | 511.84.01167 Boehringer Ingelheim Investigational Site | Ocala | Florida | United States | |
| 54 | 511.84.01111 Boehringer Ingelheim Investigational Site | Orlando | Florida | United States | |
| 55 | 511.84.01118 Boehringer Ingelheim Investigational Site | Orlando | Florida | United States | |
| 56 | 511.84.01135 Boehringer Ingelheim Investigational Site | Pembroke Pines | Florida | United States | |
| 57 | 511.84.01032 Boehringer Ingelheim Investigational Site | Plantation | Florida | United States | |
| 58 | 511.84.01175 Boehringer Ingelheim Investigational Site | Sarasota | Florida | United States | |
| 59 | 511.84.01053 Boehringer Ingelheim Investigational Site | St. Petersburg | Florida | United States | |
| 60 | 511.84.01132 Boehringer Ingelheim Investigational Site | St. Petersburg | Florida | United States | |
| 61 | 511.84.01117 Boehringer Ingelheim Investigational Site | Stuart | Florida | United States | |
| 62 | 511.84.01159 Boehringer Ingelheim Investigational Site | Tampa | Florida | United States | |
| 63 | 511.84.01170 Boehringer Ingelheim Investigational Site | Tampa | Florida | United States | |
| 64 | 511.84.01183 Boehringer Ingelheim Investigational Site | Tampa | Florida | United States | |
| 65 | 511.84.01003 Boehringer Ingelheim Investigational Site | West Palm Beach | Florida | United States | |
| 66 | 511.84.01022 Boehringer Ingelheim Investigational Site | West Palm Beach | Florida | United States | |
| 67 | 511.84.01024 Boehringer Ingelheim Investigational Site | Atlanta | Georgia | United States | |
| 68 | 511.84.01061 Boehringer Ingelheim Investigational Site | Atlanta | Georgia | United States | |
| 69 | 511.84.01205 Boehringer Ingelheim Investigational Site | Atlanta | Georgia | United States | |
| 70 | 511.84.01176 Boehringer Ingelheim Investigational Site | Marietta | Georgia | United States | |
| 71 | 511.84.01139 Boehringer Ingelheim Investigational Site | Roswell | Georgia | United States | |
| 72 | 511.84.01023 Boehringer Ingelheim Investigational Site | Sandy Springs | Georgia | United States | |
| 73 | 511.84.01179 Boehringer Ingelheim Investigational Site | Champaign | Illinois | United States | |
| 74 | 511.84.01113 Boehringer Ingelheim Investigational Site | Chicago | Illinois | United States | |
| 75 | 511.84.01165 Boehringer Ingelheim Investigational Site | Chicago | Illinois | United States | |
| 76 | 511.84.01172 Boehringer Ingelheim Investigational Site | Chicago | Illinois | United States | |
| 77 | 511.84.01143 Boehringer Ingelheim Investigational Site | Evansville | Indiana | United States | |
| 78 | 511.84.01092 Boehringer Ingelheim Investigational Site | Indianapolis | Indiana | United States | |
| 79 | 511.84.01202 Boehringer Ingelheim Investigational Site | Wichita | Kansas | United States | |
| 80 | 511.84.01049 Boehringer Ingelheim Investigational Site | Lexington | Kentucky | United States | |
| 81 | 511.84.01025 Boehringer Ingelheim Investigational Site | Baton Rouge | Louisiana | United States | |
| 82 | 511.84.01171 Boehringer Ingelheim Investigational Site | Lafayette | Louisiana | United States | |
| 83 | 511.84.01192 Boehringer Ingelheim Investigational Site | New Orleans | Louisiana | United States | |
| 84 | 511.84.01130 Boehringer Ingelheim Investigational Site | New Orlean | Louisiana | United States | |
| 85 | 511.84.01001 Boehringer Ingelheim Investigational Site | Baltimore | Maryland | United States | |
| 86 | 511.84.01120 Boehringer Ingelheim Investigational Site | Brighton | Massachusetts | United States | |
| 87 | 511.84.01030 Boehringer Ingelheim Investigational Site | Haverhill | Massachusetts | United States | |
| 88 | 511.84.01127 Boehringer Ingelheim Investigational Site | Ann Arbor | Michigan | United States | |
| 89 | 511.84.01081 Boehringer Ingelheim Investigational Site | Bingham Farms | Michigan | United States | |
| 90 | 511.84.01147 Boehringer Ingelheim Investigational Site | Bingham Farms | Michigan | United States | |
| 91 | 511.84.01041 Boehringer Ingelheim Investigational Site | Detroit | Michigan | United States | |
| 92 | 511.84.01131 Boehringer Ingelheim Investigational Site | Chaska | Minnesota | United States | |
| 93 | 511.84.01128 Boehringer Ingelheim Investigational Site | Chesterfield | Missouri | United States | |
| 94 | 511.84.01051 Boehringer Ingelheim Investigational Site | Kansas City | Missouri | United States | |
| 95 | 511.84.01034 Boehringer Ingelheim Investigational Site | St. Louis | Missouri | United States | |
| 96 | 511.84.01042 Boehringer Ingelheim Investigational Site | Billings | Montana | United States | |
| 97 | 511.84.01156 Boehringer Ingelheim Investigational Site | Omaha | Nebraska | United States | |
| 98 | 511.84.01148 Boehringer Ingelheim Investigational Site | Las Vegas | Nevada | United States | |
| 99 | 511.84.01206 Boehringer Ingelheim Investigational Site | Moorestown | New Jersey | United States | |
| 100 | 511.84.01010 Boehringer Ingelheim Investigational Site | New Brunswick | New Jersey | United States | |
| 101 | 511.84.01045 Boehringer Ingelheim Investigational Site | Albequerque | New Mexico | United States | |
| 102 | 511.84.01059 Boehringer Ingelheim Investigational Site | Bronx | New York | United States | |
| 103 | 511.84.01050 Boehringer Ingelheim Investigational Site | Endwell | New York | United States | |
| 104 | 511.84.01066 Boehringer Ingelheim Investigational Site | Poughkeepsie | New York | United States | |
| 105 | 511.84.01187 Boehringer Ingelheim Investigational Site | Purchase | New York | United States | |
| 106 | 511.84.01038 Boehringer Ingelheim Investigational Site | Rochester | New York | United States | |
| 107 | 511.84.01178 Boehringer Ingelheim Investigational Site | Chapel Hill | North Carolina | United States | |
| 108 | 511.84.01121 Boehringer Ingelheim Investigational Site | New Bern | North Carolina | United States | |
| 109 | 511.84.01119 Boehringer Ingelheim Investigational Site | Raleigh | North Carolina | United States | |
| 110 | 511.84.01072 Boehringer Ingelheim Investigational Site | Winston-Salem | North Carolina | United States | |
| 111 | 511.84.01106 Boehringer Ingelheim Investigational Site | Beachwood | Ohio | United States | |
| 112 | 511.84.01008 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | United States | |
| 113 | 511.84.01062 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | United States | |
| 114 | 511.84.01089 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | United States | |
| 115 | 511.84.01197 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | United States | |
| 116 | 511.84.01201 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | United States | |
| 117 | 511.84.01009 Boehringer Ingelheim Investigational Site | Cleveland | Ohio | United States | |
| 118 | 511.84.01014 Boehringer Ingelheim Investigational Site | Cleveland | Ohio | United States | |
| 119 | 511.84.01152 Boehringer Ingelheim Investigational Site | Cleveland | Ohio | United States | |
| 120 | 511.84.01136 Boehringer Ingelheim Investigational Site | Columbus | Ohio | United States | |
| 121 | 511.84.01149 Boehringer Ingelheim Investigational Site | Columbus | Ohio | United States | |
| 122 | 511.84.01151 Boehringer Ingelheim Investigational Site | Columbus | Ohio | United States | |
| 123 | 511.84.01150 Boehringer Ingelheim Investigational Site | Dayton | Ohio | United States | |
| 124 | 511.84.01190 Boehringer Ingelheim Investigational Site | Oklahoma City | Oklahoma | United States | |
| 125 | 511.84.01112 Planned Parenthood of Arkansas & Estrn Oklahoma, Inc | Tulsa | Oklahoma | United States | |
| 126 | 511.84.01185 Boehringer Ingelheim Investigational Site | Tulsa | Oklahoma | United States | |
| 127 | 511.84.01019 Boehringer Ingelheim Investigational Site | Eugene | Oregon | United States | |
| 128 | 511.84.01134 Boehringer Ingelheim Investigational Site | Medfod | Oregon | United States | |
| 129 | 511.84.01103 Boehringer Ingelheim Investigational Site | Portland | Oregon | United States | |
| 130 | 511.84.01088 Boehringer Ingelheim Investigational Site | Jenkintown | Pennsylvania | United States | |
| 131 | 511.84.01067 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania | United States | |
| 132 | 511.84.01153 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania | United States | |
| 133 | 511.84.01145 Boehringer Ingelheim Investigational Site | Pittsburgh | Pennsylvania | United States | |
| 134 | 511.84.01054 Boehringer Ingelheim Investigational Site | West Reading | Pennsylvania | United States | |
| 135 | 511.84.01021 Boehringer Ingelheim Investigational Site | Wilkes-Barre | Pennsylvania | United States | |
| 136 | 511.84.01060 Boehringer Ingelheim Investigational Site | Warwick | Rhode Island | United States | |
| 137 | 511.84.01063 Boehringer Ingelheim Investigational Site | Anderson | South Carolina | United States | |
| 138 | 511.84.01124 Boehringer Ingelheim Investigational Site | Columbia | South Carolina | United States | |
| 139 | 511.84.01123 Boehringer Ingelheim Investigational Site | Greenville | South Carolina | United States | |
| 140 | 511.84.01109 Boehringer Ingelheim Investigational Site | Mt. Pleasant | South Carolina | United States | |
| 141 | 511.84.01174 Boehringer Ingelheim Investigational Site | Germantown | Tennessee | United States | |
| 142 | 511.84.01163 Boehringer Ingelheim Investigational Site | Knoxville | Tennessee | United States | |
| 143 | 511.84.01026 Boehringer Ingelheim Investigational Site | Nashville | Tennessee | United States | |
| 144 | 511.84.01100 Boehringer Ingelheim Investigational Site | Nashville | Tennessee | United States | |
| 145 | 511.84.01078 Boehringer Ingelheim Investigational Site | Austin | Texas | United States | |
| 146 | 511.84.01052 Boehringer Ingelheim Investigational Site | Corpus Christi | Texas | United States | |
| 147 | 511.84.01027 Boehringer Ingelheim Investigational Site | Dallas | Texas | United States | |
| 148 | 511.84.01140 Boehringer Ingelheim Investigational Site | Dallas | Texas | United States | |
| 149 | 511.84.01084 Boehringer Ingelheim Investigational Site | Fort Worth | Texas | United States | |
| 150 | 511.84.01057 Boehringer Ingelheim Investigational Site | Houston | Texas | United States | |
| 151 | 511.84.01082 Boehringer Ingelheim Investigational Site | Houston | Texas | United States | |
| 152 | 511.84.01198 Boehringer Ingelheim Investigational Site | Houston | Texas | United States | |
| 153 | 511.84.01036 Boehringer Ingelheim Investigational Site | San Antonio | Texas | United States | |
| 154 | 511.84.01071 Boehringer Ingelheim Investigational Site | San Antonio | Texas | United States | |
| 155 | 511.84.01083 Boehringer Ingelheim Investigational Site | San Antonio | Texas | United States | |
| 156 | 511.84.01086 Boehringer Ingelheim Investigational Site | San Antonio | Texas | United States | |
| 157 | 511.84.01098 Boehringer Ingelheim Investigational Site | Waco | Texas | United States | |
| 158 | 511.84.01015 Boehringer Ingelheim Investigational Site | Salt Lake City | Utah | United States | |
| 159 | 511.84.01180 Boehringer Ingelheim Investigational Site | Sandy | Utah | United States | |
| 160 | 511.84.01028 Boehringer Ingelheim Investigational Site | Burlington | Vermont | United States | |
| 161 | 511.84.01031 Boehringer Ingelheim Investigational Site | Charlottesville | Virginia | United States | |
| 162 | 511.84.01035 Boehringer Ingelheim Investigational Site | Charlottesville | Virginia | United States | |
| 163 | 511.84.01107 Boehringer Ingelheim Investigational Site | Norfolk | Virginia | United States | |
| 164 | 511.84.01125 Boehringer Ingelheim Investigational Site | Norfolk | Virginia | United States | |
| 165 | 511.84.01076 Boehringer Ingelheim Investigational Site | Richmond | Virginia | United States | |
| 166 | 511.84.01097 Boehringer Ingelheim Investigational Site | Richmond | Virginia | United States | |
| 167 | 511.84.01196 Boehringer Ingelheim Investigational Site | Richmond | Virginia | United States | |
| 168 | 511.84.01093 Boehringer Ingelheim Investigational Site | Bellevue | Washington | United States | |
| 169 | 511.84.01141 Boehringer Ingelheim Investigational Site | Renton | Washington | United States | |
| 170 | 511.84.01012 Boehringer Ingelheim Investigational Site | Seattle | Washington | United States | |
| 171 | 511.84.01116 Boehringer Ingelheim Investigational Site | Spokane | Washington | United States | |
| 172 | 511.84.01105 Boehringer Ingelheim Investigational Site | Tacoma | Washington | United States | |
| 173 | 511.84.01177 Boehringer Ingelheim Investigational Site | Middleton | Wisconsin | United States | |
| 174 | 511.84.02007 Boehringer Ingelheim Investigational Site | Calgary | Alberta | Canada | |
| 175 | 511.84.02014 Boehringer Ingelheim Investigational Site | Coquitlam | British Columbia | Canada | |
| 176 | 511.84.02002 Boehringer Ingelheim Investigational Site | North Vancouver | British Columbia | Canada | |
| 177 | 511.84.02021 Boehringer Ingelheim Investigational Site | Surrey | British Columbia | Canada | |
| 178 | 511.84.02013 Boehringer Ingelheim Investigational Site | Vancouver | British Columbia | Canada | |
| 179 | 511.84.02015 Boehringer Ingelheim Investigational Site | Victoria | British Columbia | Canada | |
| 180 | 511.84.02023 Boehringer Ingelheim Investigational Site | Victoria | British Columbia | Canada | |
| 181 | 511.84.02017 Boehringer Ingelheim Investigational Site | Winnipeg | Manitoba | Canada | |
| 182 | 511.84.02010 Boehringer Ingelheim Investigational Site | Woodstock | New Brunswick | Canada | |
| 183 | 511.84.02012 Boehringer Ingelheim Investigational Site | Mount Pearl | Newfoundland and Labrador | Canada | |
| 184 | 511.84.02006 Boehringer Ingelheim Investigational Site | St. John's | Newfoundland and Labrador | Canada | |
| 185 | 511.84.02003 Boehringer Ingelheim Investigational Site | Halifax | Nova Scotia | Canada | |
| 186 | 511.84.02018 Boehringer Ingelheim Investigational Site | Barrie | Ontario | Canada | |
| 187 | 511.84.02009 Boehringer Ingelheim Investigational Site | Burlington | Ontario | Canada | |
| 188 | 511.84.02022 Boehringer Ingelheim Investigational Site | London | Ontario | Canada | |
| 189 | 511.84.02024 Boehringer Ingelheim Investigational Site | London | Ontario | Canada | |
| 190 | 511.84.02001 Boehringer Ingelheim Investigational Site | Ottawa | Ontario | Canada | |
| 191 | 511.84.02008 Boehringer Ingelheim Investigational Site | Ottawa | Ontario | Canada | |
| 192 | 511.84.02011 Boehringer Ingelheim Investigational Site | Montréal | Quebec | Canada | |
| 193 | 511.84.02019 Boehringer Ingelheim Investigational Site | Québec | Quebec | Canada | |
| 194 | 511.84.02005 Boehringer Ingelheim Investigational Site | Sherbrooke | Quebec | Canada | |
| 195 | 511.84.02004 Boehringer Ingelheim Investigational Site | Saskatoon | Saskatchewan | Canada | |
| 196 | 511.84.02020 Boehringer Ingelheim Investigational Site | Quebec | Canada |
Sponsors and Collaborators
- Sprout Pharmaceuticals, Inc
Investigators
- Study Chair: Boehringer Ingelheim, Boehringer Ingelheim
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Sprout Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00441558
Other Study ID Numbers:
- 511.84
First Posted:
Mar 1, 2007
Last Update Posted:
Jun 13, 2014
Last Verified:
May 1, 2014
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Flibanserin |
|---|---|
| Arm/Group Description | Flibanserin: flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily. |
| Period Title: Overall Study | |
| STARTED | 1723 |
| COMPLETED | 667 |
| NOT COMPLETED | 1056 |
Baseline Characteristics
| Arm/Group Title | Flibanserin |
|---|---|
| Arm/Group Description | Flibanserin: flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily. |
| Overall Participants | 1723 |
| Age, Customized (participants) [Number] | |
| 18-29 years |
266
15.4%
|
| 30-39 years |
749
43.5%
|
| 40-49 years |
672
39%
|
| 50 years and older |
36
2.1%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
1723
100%
|
| Male |
0
0%
|
| Race/Ethnicity, Customized (participants) [Number] | |
| White |
1492
86.6%
|
| White Hispanic |
85
4.9%
|
| Black |
119
6.9%
|
| Black Hispanic |
6
0.3%
|
| Asian |
21
1.2%
|
Outcome Measures
| Title | The Frequency of Adverse Events (Side Effects). |
|---|---|
| Description | This is a 52-week, open label trial assessing safety/tolerability of flibanserin in women with Hypoactive Sexual Desire Disorder |
| Time Frame | 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Flibanserin |
|---|---|
| Arm/Group Description | Flibanserin: flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily. |
| Measure Participants | 1723 |
| Number [participants with any adverse event] |
1272
73.8%
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Flibanserin | |
| Arm/Group Description | Flibanserin: flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily. | |
All Cause Mortality |
||
| Flibanserin | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Flibanserin | ||
| Affected / at Risk (%) | # Events | |
| Total | 15/1723 (0.9%) | |
| Cardiac disorders | ||
| Atrioventricular block complete | 1/1723 (0.1%) | |
| Bradycardia | 1/1723 (0.1%) | 1 |
| Mitral valve prolapse | 1/1723 (0.1%) | 1 |
| Endocrine disorders | ||
| Thyroid mass | 1/1723 (0.1%) | 1 |
| Infections and infestations | ||
| Abdominal abscess | 1/1723 (0.1%) | 1 |
| Appendicitis | 2/1723 (0.1%) | 2 |
| Pneumonia | 1/1723 (0.1%) | 1 |
| Urinary tract infection | 1/1723 (0.1%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Malignant melonoma | 1/1723 (0.1%) | 1 |
| Thyroid cancer | 1/1723 (0.1%) | 1 |
| Thyroid neoplasm | 1/1723 (0.1%) | 1 |
| Nervous system disorders | ||
| Cervicobrachial syndrome | 1/1723 (0.1%) | |
| Vascular disorders | ||
| Aortic aneurysm | 1/1723 (0.1%) | 1 |
| Aortic stenosis | 1/1723 (0.1%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Flibanserin | ||
| Affected / at Risk (%) | # Events | |
| Total | 995/1723 (57.7%) | |
| Gastrointestinal disorders | ||
| Nausea | 109/1723 (6.3%) | 132 |
| Nervous system disorders | ||
| Somnolence | 275/1723 (16%) | 315 |
| Fatigue | 131/1723 (7.6%) | 142 |
| Dizziness | 120/1723 (7%) | 152 |
| Headache | 113/1723 (6.6%) | 156 |
| Respiratory, thoracic and mediastinal disorders | ||
| Nasopharyngitis | 123/1723 (7.1%) | 139 |
| Upper respiratory tract infection | 124/1723 (7.2%) | 135 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Krista Barbour, Ph.D. |
|---|---|
| Organization | Sprout Pharmaceuticals |
| Phone | 9198820850 |
| kbarbour@sproutpharma.com |
Responsible Party:
Sprout Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00441558
Other Study ID Numbers:
- 511.84
First Posted:
Mar 1, 2007
Last Update Posted:
Jun 13, 2014
Last Verified:
May 1, 2014