1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder
- Conditions
- Hypoactive Sexual Desire Disorder
- Interventions
- Drug: BremelanotideOther: Placebo
- Registration Number
- NCT02333071
- Lead Sponsor
- Palatin Technologies, Inc
- Brief Summary
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an optional Open-label Extension to evaluate the efficacy of bremelanotide (BMT), administered subcutaneously (SC) on an as needed basis for the treatment of HSDD (with or without decreased arousal) in premenopausal females.
- Detailed Description
This will be a multicenter, randomized, placebo-controlled, parallel group study in up to 80 sites in the United States of America (USA) and Canada to evaluate the efficacy and safety of a fixed dose of SC BMT versus placebo on an as-needed basis under conditions of home use in premenopausal women with HSDD (with or without decreased arousal).
The study will consist of 2 phases: (1) Core Study: 4-week no-treatment qualification period, a 4-week single-blind placebo treatment period (baseline), and a 24-week double-blind treatment period where participants will self-administer placebo or BMT 1.75 mg SC via an autoinjector; and (2) Extension Phase: a 52-week open-label treatment period during which all subjects will receive BMT 1.75 mg.
Primary Objective
• To evaluate the efficacy of bremelanotide (BMT), administered subcutaneously (SC) on an as needed basis for the treatment of HSDD (with or without decreased arousal) in premenopausal females.
Secondary Objectives
* To evaluate the efficacy of BMT in premenopausal women in the double-blind Core Study, as assessed by subject responses to questionnaires measuring sexual function, treatment satisfaction, and distress associated with sexual dysfunction.
* To evaluate the safety of BMT in premenopausal women in the double-blind Core Study.
* To evaluate the safety of long-term therapy with BMT in the open label Extension Phase.
* To evaluate the efficacy of long-term therapy with BMT in the open-label Extension Phase.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 723
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo (PBO/BMT) Placebo (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 Bremelanotide (BMT/BMT) Bremelanotide (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 Placebo (PBO/BMT) Bremelanotide (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
- Primary Outcome Measures
Name Time Method Efficacy of a Fixed Dose of Bremelanotide as Measured by FSFI (Question Q1 and Q2), 28-day Recall. 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) As measured by change from baseline to end-of-study in the desire domain from the FSFI (Question Q1 and Q2), 28-day recall, co-primary endpoint - FSFI desire domain.
FSFI = Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. Its six subscales assess desire, arousal, lubrication, orgasm, satisfaction, and pain, by summing individual items that comprise the subscale and multiplying the sum by a factor, resulting in a score ranging from 1.2 to 6. Increasing scores on this scale represent an increase in sexual desire and is a positive outcome.Efficacy of a Fixed Dose of Bremelanotide as Measured by FSDS-DAO (Item 13) 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) As measured by the change from baseline to End-of-Study of the Core Study in the bothered by low desire item from the FSDS-DAO (Female Sexual Distress Scale - Desire Arousal Orgasm) (item 13).: co-primary endpoint - FSDS-DAO bothered by low desire item 13.
Responses range from 0 (never) to 4 (always). Decreasing scores on this scale represent an increase in sexual desire (positive outcome).
- Secondary Outcome Measures
Name Time Method Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Total FSFI Total Score 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) FSFI = Female Sexual Function Index: a multidimensional self-report instrument for the assessment of female sexual function.
The FSFI total score is on a scale ranging from 2 to 36. Increasing scores on this scale represent an increase in sexual desire and is a positive outcome.Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Mean Satisfaction With Sexual Arousal (Q7) From the FSEP-R 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) FSEP-R=Female Sexual Encounter Profile - Revised Scores range from 0 (not at all aroused) to 3 (highly aroused) for an individual encounter. A higher score indicates a better outcome.
Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in Mean Satisfaction With Desire Score (Q4) From FSEP-R 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) Patient's change, from baseline to end of study (EOS), in mean satisfaction with desire score, as measured by a response to question 4 (Q4) of the Female Sexual Encounter Profile-Revised questionnaire (FSEP-R). Responses range from 1 (Not at all satisfied) to 4 (Completely satisfied).
Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the FSDS-DAO Total Score 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) FSDS-DAO = Female Sexual Distress Scale - Desire/Arousal/Orgasm Scores range from 0 (never feel bothered) to 60 (always feel bothered).
Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Mean Level of Sexual Arousal (Q6) From the FSEP-R 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) FSEP-R=Female Sexual Encounter Profile - Revised Scores range from 0 (not at all aroused) to 3 (highly aroused) for an individual encounter. A higher score indicates a better outcome.
Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Scored Time Spent Being Concerned by Difficulty With Sexual Arousal (Q14) From the FSDS-DAO 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) FSDS-DAO = Female Sexual Distress Scale-Desire/Arousal/Orgasm. The outcome reported is the mean score from the 15-item self assessment. The result is on a scale ranging from 0 ("never") to 4 ("always").
A higher score indicates a worse outcome.Change From Baseline to End of Study in the Total Score for FSDS-DAO (Item 13) Throughout the Entirety of the Double-blind Phase 24 weeks (Main Study) FSDS-DAO = Female Sexual Distress Scale - Desire/Arousal/Orgasm. The FSDS-DAO is a validated 15-item self-assessment of sexual feelings and problems. The score is on a scale ranging from 0 ("never") to 4 ("always"). A higher score indicates a worse outcome.
The score is the mean change from Baseline observed at EOS (Baseline score - EOS score) for FSDS-DAO Item 13 (feeling bothered by low sexual desire).Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Number of SSEs Associated With Study Drug Administration Throughout the Entirety of the Double-blind Phase 24 weeks (Main Study) Mean change from Baseline to EOS in the number of satisfying sexual events SSEs that occurred within 16 hours of study drug dosing and reported within 72 hours. An increase in number reflects a positive outcome.
Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in Mean Desire Score (Q3) From FSEP-R 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) Scores range from 0 (no desire) to 3 (high desire) for an individual encounter. Change from baseline is computed as the mean of the scores from all encounters for a subject in the last 28 days minus the mean of the scores from all encounters for the subject in the last 28 days before Visit 3. Only FSEP-R data pertaining to encounters recorded within 72 hours of the encounter are included.
Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Number of Satisfying Sexual Events (SSEs) Associated With Study Drug Administration 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) Patient's change, from baseline to end of study (EOS), in the number of Satisfying Sexual Events (SSEs), as measured by a response of 'Yes' to question 10 (Q10) of the Female Sexual Encounter Profile-Revised questionnaire (FSEP-R). The end point was calculated as the number of events during the last 4 weeks of treatment with Q10 = Yes minus the number of baseline events with Q10 = Yes.
Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Total Number of SSEs 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) Change from Baseline to EOS in the total number of satisfying sexual events SSEs that occurred within 16 hours of a study drug dosing and reported within 72 hours. A higher value indicates a better outcome.
Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Arousal Domain of the FSFI (Q3 to Q6) 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE) FSFI = Female Sexual Function Index: a multidimensional self-report instrument for the assessment of female sexual function.
The score is on a scale ranging from 1.2 to 6. Increasing scores on this scale represent an increase in sexual desire and is a better outcome.Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Desire Domain of the FSFI (Q1 to Q2) Throughout the Entirety of the Double-blind Phase 24 weeks (Main Study) FSFI = Female Sexual Function Index: a multidimensional self-report instrument for the assessment of female sexual function.
The score is on a scale ranging from 1.2 to 6. Increasing scores on this scale represent an increase in sexual desire and is a positive outcome.
Trial Locations
- Locations (91)
Palatin Clinical Site 142
🇺🇸Savannah, Georgia, United States
Palatin Clinical Site 183
🇺🇸Bangor, Maine, United States
Palatin Clinical Site 108
🇺🇸Melbourne, Florida, United States
Palatin Clinical Site 101
🇺🇸West Palm Beach, Florida, United States
Palatin Clinical Site 116
🇺🇸Decatur, Georgia, United States
Palatin Clinical Site 130
🇺🇸Bradenton, Florida, United States
Palatin Clinical Site 131
🇺🇸South Miami, Florida, United States
Palatin Clinical Site 120
🇺🇸Moorestown, New Jersey, United States
Palatin Clinical Site 301
🇨🇦Toronto, Ontario, Canada
Palatin Clinical Site 119
🇺🇸Boston, Massachusetts, United States
Palatin Clinical Site 109
🇺🇸Las Vegas, Nevada, United States
Palatin Clinical Site 195
🇺🇸Las Vegas, Nevada, United States
Palatin Clinical Site 141
🇺🇸San Diego, California, United States
Palatin Clinical Site 303
🇨🇦Kentville, Nova Scotia, Canada
Palatin Clinical Site 160
🇺🇸Centennial, Colorado, United States
Palatin Clinical Site 139
🇺🇸Fargo, North Dakota, United States
Palatin Clinical Site 155
🇺🇸Overland Park, Kansas, United States
Palatin Clinical Site 104
🇺🇸Wichita, Kansas, United States
Palatin Clinical Site 121
🇺🇸Birmingham, Alabama, United States
Palatin Clinical Site 168
🇺🇸Omaha, Nebraska, United States
Palatin Clinical Site 146
🇺🇸Portland, Oregon, United States
Palatin Clinical Site 110
🇺🇸Huntsville, Alabama, United States
Palatin Clinical Site 106
🇺🇸Mobile, Alabama, United States
Palatin Clinical Site 166
🇺🇸Little Rock, Arkansas, United States
Palatin Clinical Site 149
🇺🇸Scottsdale, Arizona, United States
Palatin Clinical Site 157
🇺🇸Tucson, Arizona, United States
Palatin Clinical Site 102
🇺🇸National City, California, United States
Palatin Clinical Site 152
🇺🇸Orange, California, United States
Palatin Clinical Site 164
🇺🇸Oceanside, California, United States
Palatin Clinical Site 187
🇺🇸Walnut Creek, California, United States
Palatin Clinical Site 134
🇺🇸Jacksonville, Florida, United States
Palatin Clinical Site 128
🇺🇸Hollywood, Florida, United States
Palatin Clinical Site 144
🇺🇸Saint Petersburg, Florida, United States
Palatin Clinical Site 171
🇺🇸Meridian, Idaho, United States
Palatin Clinical Site 179
🇺🇸Evansville, Indiana, United States
Palatin Clinical Site 165
🇺🇸Lafayette, Indiana, United States
Palatin Clinical Site 154
🇺🇸Mishawaka, Indiana, United States
Palatin Clinical Site 184
🇺🇸West Des Moines, Iowa, United States
Palatin Clinical Site 194
🇺🇸Eunice, Louisiana, United States
Palatin Clinical Site 159
🇺🇸Annapolis, Maryland, United States
Palatin Clinical Site 126
🇺🇸Watertown, Massachusetts, United States
Palatin Clinical Site 181
🇺🇸Rochester, Michigan, United States
Palatin Clinical Site 163
🇺🇸Bingham Farms, Michigan, United States
Palatin Clinical Site 182
🇺🇸Olive Branch, Mississippi, United States
Palatin Clinical Site 170
🇺🇸Saint Louis, Missouri, United States
Palatin Clinical Site 180
🇺🇸Billings, Montana, United States
Palatin Clinical Site 192
🇺🇸Norfolk, Nebraska, United States
Palatin Clinical Site 111
🇺🇸Las Vegas, Nevada, United States
Palatin Clinical Site 125
🇺🇸Las Vegas, Nevada, United States
Palatin Clinical Site 123
🇺🇸Plainsboro, New Jersey, United States
Palatin Clinical Site 124
🇺🇸Albuquerque, New Mexico, United States
Palatin Clinical Site 189
🇺🇸Johnson City, New York, United States
Palatin Clinical Site 127
🇺🇸Poughkeepsie, New York, United States
Palatin Clinical Site 107
🇺🇸New York, New York, United States
Palatin Clinical Site 158
🇺🇸Port Jefferson, New York, United States
Palatin Clinical Site 137
🇺🇸Charlotte, North Carolina, United States
Palatin Clinical Site 190
🇺🇸Rochester, New York, United States
Palatin Clinical Site 112
🇺🇸Columbus, Ohio, United States
Palatin Clinical Site 122
🇺🇸Beachwood, Ohio, United States
Palatin Clinical Site 140
🇺🇸Akron, Ohio, United States
Palatin Clinical Site 151
🇺🇸Cincinnati, Ohio, United States
Palatin Clinical Site 132
🇺🇸Medford, Oregon, United States
Palatin Clinical Site 115
🇺🇸Englewood, Ohio, United States
Palatin Clinical Site 169
🇺🇸Jenkintown, Pennsylvania, United States
Palatin Clinical Site 172
🇺🇸Media, Pennsylvania, United States
Palatin Clinical Site 143
🇺🇸Bluffton, South Carolina, United States
Palatin Clinical Site 162
🇺🇸Anderson, South Carolina, United States
Palatin Clinical Site 117
🇺🇸Warwick, Rhode Island, United States
Palatin Clinical Site 129
🇺🇸Nashville, Tennessee, United States
Palatin Clinical Site 161
🇺🇸Memphis, Tennessee, United States
Palatin Clinical Site 145
🇺🇸Mount Pleasant, South Carolina, United States
Palatin Clinical Site 174
🇺🇸Bryan, Texas, United States
Palatin Clinical Site 113
🇺🇸Dallas, Texas, United States
Palatin Clinical Site 176
🇺🇸Sugar Land, Texas, United States
Palatin Clinical Site 118
🇺🇸San Antonio, Texas, United States
Palatin Clinical Site 100
🇺🇸Murray, Utah, United States
Palatin Clinical Site 138
🇺🇸Virginia Beach, Virginia, United States
Palatin Clinical Site 103
🇺🇸Charlottesville, Virginia, United States
Palatin Clinical Site 133
🇺🇸Spokane, Washington, United States
Palatin Clinical Site 193
🇺🇸Middleton, Wisconsin, United States
Palatin Clinical Site 150
🇺🇸Tacoma, Washington, United States
Palatin Clinical Site 304
🇨🇦Halifax, Nova Scotia, Canada
Palatin Clinical Site 302
🇨🇦Saint Romuald, Quebec, Canada
Palatin Clinical Site 188
🇺🇸Sacramento, California, United States
Palatin Clinical Site 191
🇺🇸Louisville, Kentucky, United States
Palatin Clinical Site 105
🇺🇸Orlando, Florida, United States
Palatin Clinical Site 135
🇺🇸Winston-Salem, North Carolina, United States
Palatin Clinical Site 156
🇺🇸Winston-Salem, North Carolina, United States
Palatin Clinical Site 185
🇺🇸Colorado Springs, Colorado, United States
Palatin Clinical Site 186
🇺🇸New Orleans, Louisiana, United States
Palatin Clinical Site 114
🇺🇸Mount Pleasant, South Carolina, United States