1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder
NCT ID: NCT02333071
Last Updated: 2021-04-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
723 participants
INTERVENTIONAL
2014-12-31
2017-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Bremelanotide (BMT/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
Bremelanotide
A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)
Placebo (PBO/BMT)
(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
A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)
Placebo
Placebo
Interventions
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Bremelanotide
A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Is willing and able to understand and comply with all study requirements
* Has a normal pelvic examination at screening
Exclusion Criteria
* Not currently under treatment for the sexual dysfunction and willing to forego other treatments through the course of the clinical trial
18 Years
FEMALE
No
Sponsors
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Palatin Technologies, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Jordan
Role: STUDY_DIRECTOR
Palatin Technologies, Inc
Locations
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Palatin Clinical Site 121
Birmingham, Alabama, United States
Palatin Clinical Site 110
Huntsville, Alabama, United States
Palatin Clinical Site 106
Mobile, Alabama, United States
Palatin Clinical Site 149
Scottsdale, Arizona, United States
Palatin Clinical Site 157
Tucson, Arizona, United States
Palatin Clinical Site 166
Little Rock, Arkansas, United States
Palatin Clinical Site 102
National City, California, United States
Palatin Clinical Site 164
Oceanside, California, United States
Palatin Clinical Site 152
Orange, California, United States
Palatin Clinical Site 188
Sacramento, California, United States
Palatin Clinical Site 141
San Diego, California, United States
Palatin Clinical Site 187
Walnut Creek, California, United States
Palatin Clinical Site 160
Centennial, Colorado, United States
Palatin Clinical Site 185
Colorado Springs, Colorado, United States
Palatin Clinical Site 130
Bradenton, Florida, United States
Palatin Clinical Site 128
Hollywood, Florida, United States
Palatin Clinical Site 134
Jacksonville, Florida, United States
Palatin Clinical Site 108
Melbourne, Florida, United States
Palatin Clinical Site 105
Orlando, Florida, United States
Palatin Clinical Site 131
South Miami, Florida, United States
Palatin Clinical Site 144
St. Petersburg, Florida, United States
Palatin Clinical Site 101
West Palm Beach, Florida, United States
Palatin Clinical Site 116
Decatur, Georgia, United States
Palatin Clinical Site 142
Savannah, Georgia, 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 155
Overland Park, Kansas, United States
Palatin Clinical Site 104
Wichita, Kansas, United States
Palatin Clinical Site 191
Louisville, Kentucky, United States
Palatin Clinical Site 194
Eunice, Louisiana, United States
Palatin Clinical Site 186
New Orleans, Louisiana, United States
Palatin Clinical Site 183
Bangor, Maine, United States
Palatin Clinical Site 159
Annapolis, Maryland, United States
Palatin Clinical Site 119
Boston, Massachusetts, United States
Palatin Clinical Site 126
Watertown, Massachusetts, United States
Palatin Clinical Site 163
Bingham Farms, Michigan, United States
Palatin Clinical Site 181
Rochester, Michigan, United States
Palatin Clinical Site 182
Olive Branch, Mississippi, United States
Palatin Clinical Site 170
St Louis, Missouri, United States
Palatin Clinical Site 180
Billings, Montana, United States
Palatin Clinical Site 192
Norfolk, Nebraska, United States
Palatin Clinical Site 168
Omaha, Nebraska, United States
Palatin Clinical Site 111
Las Vegas, Nevada, United States
Palatin Clinical Site 125
Las Vegas, Nevada, United States
Palatin Clinical Site 109
Las Vegas, Nevada, United States
Palatin Clinical Site 195
Las Vegas, Nevada, United States
Palatin Clinical Site 120
Moorestown, New Jersey, 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 107
New York, New York, United States
Palatin Clinical Site 158
Port Jefferson, New York, United States
Palatin Clinical Site 127
Poughkeepsie, New York, United States
Palatin Clinical Site 190
Rochester, New York, United States
Palatin Clinical Site 137
Charlotte, North Carolina, 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 139
Fargo, North Dakota, United States
Palatin Clinical Site 140
Akron, Ohio, United States
Palatin Clinical Site 122
Beachwood, Ohio, United States
Palatin Clinical Site 151
Cincinnati, Ohio, United States
Palatin Clinical Site 112
Columbus, Ohio, United States
Palatin Clinical Site 115
Englewood, Ohio, United States
Palatin Clinical Site 132
Medford, Oregon, United States
Palatin Clinical Site 146
Portland, Oregon, United States
Palatin Clinical Site 169
Jenkintown, Pennsylvania, United States
Palatin Clinical Site 172
Media, Pennsylvania, United States
Palatin Clinical Site 117
Warwick, Rhode Island, United States
Palatin Clinical Site 162
Anderson, South Carolina, United States
Palatin Clinical Site 143
Bluffton, South Carolina, United States
Palatin Clinical Site 114
Mt. Pleasant, South Carolina, United States
Palatin Clinical Site 145
Mt. Pleasant, South Carolina, United States
Palatin Clinical Site 161
Memphis, Tennessee, United States
Palatin Clinical Site 129
Nashville, Tennessee, United States
Palatin Clinical Site 174
Bryan, Texas, United States
Palatin Clinical Site 113
Dallas, Texas, United States
Palatin Clinical Site 118
San Antonio, Texas, United States
Palatin Clinical Site 176
Sugar Land, Texas, United States
Palatin Clinical Site 100
Murray, Utah, United States
Palatin Clinical Site 103
Charlottesville, Virginia, United States
Palatin Clinical Site 138
Virginia Beach, Virginia, United States
Palatin Clinical Site 133
Spokane, Washington, United States
Palatin Clinical Site 150
Tacoma, Washington, United States
Palatin Clinical Site 193
Middleton, Wisconsin, United States
Palatin Clinical Site 304
Halifax, Nova Scotia, Canada
Palatin Clinical Site 303
Kentville, Nova Scotia, Canada
Palatin Clinical Site 301
Toronto, Ontario, Canada
Palatin Clinical Site 302
Saint Romuald, Quebec, Canada
Countries
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References
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Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.
Spielmans GI, Ellefson EM. Small Effects, Questionable Outcomes: Bremelanotide for Hypoactive Sexual Desire Disorder. J Sex Res. 2024 May;61(4):540-561. doi: 10.1080/00224499.2023.2175192. Epub 2023 Feb 21.
Clayton AH, Kingsberg SA, Portman D, Sadiq A, Krop J, Jordan R, Lucas J, Simon JA. Safety Profile of Bremelanotide Across the Clinical Development Program. J Womens Health (Larchmt). 2022 Feb;31(2):171-182. doi: 10.1089/jwh.2021.0191.
Koochaki P, Revicki D, Wilson H, Pokrzywinski R, Jordan R, Lucas J, Williams LA, Sadiq A, Krop J. The Patient Experience of Premenopausal Women Treated with Bremelanotide for Hypoactive Sexual Desire Disorder: RECONNECT Exit Study Results. J Womens Health (Larchmt). 2021 Apr;30(4):587-595. doi: 10.1089/jwh.2020.8460. Epub 2021 Feb 3.
Revicki DA, Althof SE, Derogatis LR, Kingsberg SA, Wilson H, Sadiq A, Krop J, Jordan R, Lucas J. Reliability and validity of the elements of desire questionnaire in premenopausal women with hypoactive sexual desire disorder. J Patient Rep Outcomes. 2020 Oct 8;4(1):82. doi: 10.1186/s41687-020-00241-6.
Simon JA, Kingsberg SA, Portman D, Williams LA, Krop J, Jordan R, Lucas J, Clayton AH. Long-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder. Obstet Gynecol. 2019 Nov;134(5):909-917. doi: 10.1097/AOG.0000000000003514.
Kingsberg SA, Clayton AH, Portman D, Williams LA, Krop J, Jordan R, Lucas J, Simon JA. Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials. Obstet Gynecol. 2019 Nov;134(5):899-908. doi: 10.1097/AOG.0000000000003500.
Clayton AH, Lucas J, DeRogatis LR, Jordan R. Phase I Randomized Placebo-controlled, Double-blind Study of the Safety and Tolerability of Bremelanotide Coadministered With Ethanol in Healthy Male and Female Participants. Clin Ther. 2017 Mar;39(3):514-526.e14. doi: 10.1016/j.clinthera.2017.01.018. Epub 2017 Feb 9.
Other Identifiers
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Reconnect Study
Identifier Type: OTHER
Identifier Source: secondary_id
BMT-301
Identifier Type: -
Identifier Source: org_study_id
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