1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (HSDD)
Hypoactive Sexual Desire Disorder
About this trial
This is an interventional treatment trial for Hypoactive Sexual Desire Disorder focused on measuring HSDD, Female Sexual Desire Disorder
Eligibility Criteria
Main Inclusion Criteria:
- Has met diagnostic criteria for HSDD for at least 6 months
- Is willing and able to understand and comply with all study requirements
- Has a normal pelvic examination at screening
Main Exclusion Criteria:
- Subjects should be generally healthy premenopausal females with no psychological, gynecological or urological conditions which might contribute to the sexual dysfunction, compromise study participation, or confound interpretation of the study results
- Not currently under treatment for the sexual dysfunction and willing to forego other treatments through the course of the clinical trial
Sites / Locations
- Palatin Clinical Site 121
- Palatin Clinical Site 110
- Palatin Clinical Site 106
- Palatin Clinical Site 149
- Palatin Clinical Site 157
- Palatin Clinical Site 166
- Palatin Clinical Site 102
- Palatin Clinical Site 164
- Palatin Clinical Site 152
- Palatin Clinical Site 188
- Palatin Clinical Site 141
- Palatin Clinical Site 187
- Palatin Clinical Site 160
- Palatin Clinical Site 185
- Palatin Clinical Site 130
- Palatin Clinical Site 128
- Palatin Clinical Site 134
- Palatin Clinical Site 108
- Palatin Clinical Site 105
- Palatin Clinical Site 144
- Palatin Clinical Site 131
- Palatin Clinical Site 101
- Palatin Clinical Site 116
- Palatin Clinical Site 142
- Palatin Clinical Site 171
- Palatin Clinical Site 179
- Palatin Clinical Site 165
- Palatin Clinical Site 154
- Palatin Clinical Site 184
- Palatin Clinical Site 155
- Palatin Clinical Site 104
- Palatin Clinical Site 191
- Palatin Clinical Site 194
- Palatin Clinical Site 186
- Palatin Clinical Site 183
- Palatin Clinical Site 159
- Palatin Clinical Site 119
- Palatin Clinical Site 126
- Palatin Clinical Site 163
- Palatin Clinical Site 181
- Palatin Clinical Site 182
- Palatin Clinical Site 170
- Palatin Clinical Site 180
- Palatin Clinical Site 192
- Palatin Clinical Site 168
- Palatin Clinical Site 111
- Palatin Clinical Site 125
- Palatin Clinical Site 109
- Palatin Clinical Site 195
- Palatin Clinical Site 120
- Palatin Clinical Site 123
- Palatin Clinical Site 124
- Palatin Clinical Site 189
- Palatin Clinical Site 107
- Palatin Clinical Site 158
- Palatin Clinical Site 127
- Palatin Clinical Site 190
- Palatin Clinical Site 137
- Palatin Clinical Site 135
- Palatin Clinical Site 156
- Palatin Clinical Site 139
- Palatin Clinical Site 140
- Palatin Clinical Site 122
- Palatin Clinical Site 151
- Palatin Clinical Site 112
- Palatin Clinical Site 115
- Palatin Clinical Site 132
- Palatin Clinical Site 146
- Palatin Clinical Site 169
- Palatin Clinical Site 172
- Palatin Clinical Site 117
- Palatin Clinical Site 162
- Palatin Clinical Site 143
- Palatin Clinical Site 114
- Palatin Clinical Site 145
- Palatin Clinical Site 161
- Palatin Clinical Site 129
- Palatin Clinical Site 174
- Palatin Clinical Site 113
- Palatin Clinical Site 118
- Palatin Clinical Site 176
- Palatin Clinical Site 100
- Palatin Clinical Site 103
- Palatin Clinical Site 138
- Palatin Clinical Site 133
- Palatin Clinical Site 150
- Palatin Clinical Site 193
- Palatin Clinical Site 304
- Palatin Clinical Site 303
- Palatin Clinical Site 301
- Palatin Clinical Site 302
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Bremelanotide (BMT/BMT)
Placebo (PBO/BMT)
(Main Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks (OLE Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks
(Main Study) PBO administered SC on an as-desired basis for 24 weeks (OLE Study) subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks