Clinical trial NCT02333071: 1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder
Official title: Phase 3, Randomized, Double-blind, Placebo-controlled, Trial With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Subcutaneously Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (HSDD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypoactive Sexual Desire Disorder
Keywords: HSDD
Female Sexual Desire Disorder
Lead sponsor: Palatin Technologies, Inc
Sponsor class: INDUSTRY
First posted: 2015-01-07
Enrollment: 723
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Efficacy of a Fixed Dose of Bremelanotide as Measured by FSFI (Question Q1 and Q2), 28-day Recall.
timeFrame: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
measure: Efficacy of a Fixed Dose of Bremelanotide as Measured by FSDS-DAO (Item 13)
timeFrame: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Secondary outcomes:
measure: 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
timeFrame: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
measure: 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
timeFrame: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
measure: 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
timeFrame: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
measure: Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the FSDS-DAO Total Score
timeFrame: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
measure: Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Total FSFI Total Score
timeFrame: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
measure: 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
timeFrame: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
measure: 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
timeFrame: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
measure: 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
timeFrame: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
measure: 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)
timeFrame: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
measure: Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Total Number of SSEs
timeFrame: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
measure: 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
timeFrame: 24 weeks (Main Study)
measure: Change From Baseline to End of Study in the Total Score for FSDS-DAO (Item 13) Throughout the Entirety of the Double-blind Phase
timeFrame: 24 weeks (Main Study)
measure: 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
timeFrame: 24 weeks (Main Study)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Palatin Clinical Site 121
state: Alabama
city: Huntsville
country: United States
facility: Palatin Clinical Site 110
state: Alabama
city: Mobile
country: United States
facility: Palatin Clinical Site 106
state: Alabama
city: Scottsdale
country: United States
facility: Palatin Clinical Site 149
state: Arizona
city: Tucson
country: United States
facility: Palatin Clinical Site 157
state: Arizona
city: Little Rock
country: United States
facility: Palatin Clinical Site 166
state: Arkansas
city: National City
country: United States
facility: Palatin Clinical Site 102
state: California
city: Oceanside
country: United States
facility: Palatin Clinical Site 164
state: California
city: Orange
country: United States
facility: Palatin Clinical Site 152
state: California
city: Sacramento
country: United States
facility: Palatin Clinical Site 188
state: California
city: San Diego
country: United States
facility: Palatin Clinical Site 141
state: California
city: Walnut Creek
country: United States
facility: Palatin Clinical Site 187
state: California
city: Centennial
country: United States
facility: Palatin Clinical Site 160
state: Colorado
city: Colorado Springs
country: United States
facility: Palatin Clinical Site 185
state: Colorado
city: Bradenton
country: United States
facility: Palatin Clinical Site 130
state: Florida
city: Hollywood
country: United States
facility: Palatin Clinical Site 128
state: Florida
city: Jacksonville
country: United States
facility: Palatin Clinical Site 134
state: Florida
city: Melbourne
country: United States
facility: Palatin Clinical Site 108
state: Florida
city: Orlando
country: United States
facility: Palatin Clinical Site 105
state: Florida
city: Saint Petersburg
country: United States
facility: Palatin Clinical Site 144
state: Florida
city: South Miami
country: United States
facility: Palatin Clinical Site 131
state: Florida
city: West Palm Beach
country: United States
facility: Palatin Clinical Site 101
state: Florida
city: Decatur
country: United States
facility: Palatin Clinical Site 116
state: Georgia
city: Savannah
country: United States
facility: Palatin Clinical Site 142
state: Georgia
city: Meridian
country: United States
facility: Palatin Clinical Site 171
state: Idaho
city: Evansville
country: United States
facility: Palatin Clinical Site 179
state: Indiana
city: Lafayette
country: United States
facility: Palatin Clinical Site 165
state: Indiana
city: Mishawaka
country: United States
facility: Palatin Clinical Site 154
state: Indiana
city: West Des Moines
country: United States
facility: Palatin Clinical Site 184
state: Iowa
city: Overland Park
country: United States
facility: Palatin Clinical Site 155
state: Kansas
city: Wichita
country: United States
facility: Palatin Clinical Site 104
state: Kansas
city: Louisville
country: United States
facility: Palatin Clinical Site 191
state: Kentucky
city: Eunice
country: United States
facility: Palatin Clinical Site 194
state: Louisiana
city: New Orleans
country: United States
facility: Palatin Clinical Site 186
state: Louisiana
city: Bangor
country: United States
facility: Palatin Clinical Site 183
state: Maine
city: Annapolis
country: United States
facility: Palatin Clinical Site 159
state: Maryland
city: Boston
country: United States
facility: Palatin Clinical Site 119
state: Massachusetts
city: Watertown
country: United States
facility: Palatin Clinical Site 126
state: Massachusetts
city: Bingham Farms
country: United States
facility: Palatin Clinical Site 163
state: Michigan
city: Rochester
country: United States
facility: Palatin Clinical Site 181
state: Michigan
city: Olive Branch
country: United States
facility: Palatin Clinical Site 182
state: Mississippi
city: Saint Louis
country: United States
facility: Palatin Clinical Site 170
state: Missouri
city: Billings
country: United States
facility: Palatin Clinical Site 180
state: Montana
city: Norfolk
country: United States
facility: Palatin Clinical Site 192
state: Nebraska
city: Omaha
country: United States
facility: Palatin Clinical Site 168
state: Nebraska
city: Las Vegas
country: United States
facility: Palatin Clinical Site 111
state: Nevada
city: Las Vegas
country: United States
facility: Palatin Clinical Site 125
state: Nevada
city: Las Vegas
country: United States
facility: Palatin Clinical Site 109
state: Nevada
city: Las Vegas
country: United States
facility: Palatin Clinical Site 195
state: Nevada
city: Moorestown
country: United States
facility: Palatin Clinical Site 120
state: New Jersey
city: Plainsboro
country: United States
facility: Palatin Clinical Site 123
state: New Jersey
city: Albuquerque
country: United States
facility: Palatin Clinical Site 124
state: New Mexico
city: Johnson City
country: United States
facility: Palatin Clinical Site 189
state: New York
city: New York
country: United States
facility: Palatin Clinical Site 107
state: New York
city: Port Jefferson
country: United States
facility: Palatin Clinical Site 158
state: New York
city: Poughkeepsie
country: United States
facility: Palatin Clinical Site 127
state: New York
city: Rochester
country: United States
facility: Palatin Clinical Site 190
state: New York
city: Charlotte
country: United States
facility: Palatin Clinical Site 137
state: North Carolina
city: Winston-Salem
country: United States
facility: Palatin Clinical Site 135
state: North Carolina
city: Winston-Salem
country: United States
facility: Palatin Clinical Site 156
state: North Carolina
city: Fargo
country: United States
facility: Palatin Clinical Site 139
state: North Dakota
city: Akron
country: United States
facility: Palatin Clinical Site 140
state: Ohio
city: Beachwood
country: United States
facility: Palatin Clinical Site 122
state: Ohio
city: Cincinnati
country: United States
facility: Palatin Clinical Site 151
state: Ohio
city: Columbus
country: United States
facility: Palatin Clinical Site 112
state: Ohio
city: Englewood
country: United States
facility: Palatin Clinical Site 115
state: Ohio
city: Medford
country: United States
facility: Palatin Clinical Site 132
state: Oregon
city: Portland
country: United States
facility: Palatin Clinical Site 146
state: Oregon
city: Jenkintown
country: United States
facility: Palatin Clinical Site 169
state: Pennsylvania
city: Media
country: United States
facility: Palatin Clinical Site 172
state: Pennsylvania
city: Warwick
country: United States
facility: Palatin Clinical Site 117
state: Rhode Island
city: Anderson
country: United States
facility: Palatin Clinical Site 162
state: South Carolina
city: Bluffton
country: United States
facility: Palatin Clinical Site 143
state: South Carolina
city: Mount Pleasant
country: United States
facility: Palatin Clinical Site 114
state: South Carolina
city: Mount Pleasant
country: United States
facility: Palatin Clinical Site 145
state: South Carolina
city: Memphis
country: United States
facility: Palatin Clinical Site 161
state: Tennessee
city: Nashville
country: United States
facility: Palatin Clinical Site 129
state: Tennessee
city: Bryan
country: United States
facility: Palatin Clinical Site 174
state: Texas
city: Dallas
country: United States
facility: Palatin Clinical Site 113
state: Texas
city: San Antonio
country: United States
facility: Palatin Clinical Site 118
state: Texas
city: Sugar Land
country: United States
facility: Palatin Clinical Site 176
state: Texas
city: Murray
country: United States
facility: Palatin Clinical Site 100
state: Utah
city: Charlottesville
country: United States
facility: Palatin Clinical Site 103
state: Virginia
city: Virginia Beach
country: United States
facility: Palatin Clinical Site 138
state: Virginia
city: Spokane
country: United States
facility: Palatin Clinical Site 133
state: Washington
city: Tacoma
country: United States
facility: Palatin Clinical Site 150
state: Washington
city: Middleton
country: United States
facility: Palatin Clinical Site 193
state: Wisconsin
city: Halifax
country: Canada
facility: Palatin Clinical Site 304
state: Nova Scotia
city: Kentville
country: Canada
facility: Palatin Clinical Site 303
state: Nova Scotia
city: Toronto
country: Canada
facility: Palatin Clinical Site 301
state: Ontario
city: Saint Romuald
country: Canada
facility: Palatin Clinical Site 302
state: Quebec
Study officials:
affiliation: Palatin Technologies, Inc
name: Robert Jordan
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.