Clinical trial NCT02338960: 2. 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
decreased desire
female sexual dysfunction
Lead sponsor: Palatin Technologies, Inc
Sponsor class: INDUSTRY
Collaborators: name: AMAG Pharmaceuticals, Inc.
First posted: 2015-01-15
Enrollment: 714
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 (EOS) 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 the Change in Baseline to End of Study in Mean Desire Score (Q3) 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 the Change in 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 the Change in 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 the Change in Baseline to End of Study in the 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 the Change in 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 the Change in 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 the Change in 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 the Change in 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 the Change in 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 the Change in 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: Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Score for Feeling Bothered by Low Sexual Desire as Measured by the 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 the Change in 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 242
state: Alabama
city: Phoenix
country: United States
facility: Palatin Clinical Site 218
state: Arizona
city: Tucson
country: United States
facility: Palatin Clinical Site 254
state: Arizona
city: Hot Springs
country: United States
facility: Palatin Clinical Site 207
state: Arkansas
city: Beverly Hills
country: United States
facility: Palatin Clinical Site 258
state: California
city: Garden Grove
country: United States
facility: Palatin Clinical Site 256
state: California
city: Los Angeles
country: United States
facility: Palatin Clinical Site 291
state: California
city: Oakland
country: United States
facility: Palatin Clinical Site 270
state: California
city: San Diego
country: United States
facility: Palatin Clinical Site 210
state: California
city: San Diego
country: United States
facility: Palatin Clinical Site 251
state: California
city: Sherman Oaks
country: United States
facility: Palatin Clinical Site 272
state: California
city: Tarzana
country: United States
facility: Palatin Clinical Site 253
state: California
city: Denver
country: United States
facility: Palatin Clinical Site 212
state: Colorado
city: Denver
country: United States
facility: Palatin Clinical Site 219
state: Colorado
city: Lakewood
country: United States
facility: Palatin Clinical Site 243
state: Colorado
city: New London
country: United States
facility: Palatin Clinical Site 211
state: Connecticut
city: Waterbury
country: United States
facility: Palatin Clinical Site 229
state: Connecticut
city: Washington
country: United States
facility: Palatin Clinical Site 202
state: District of Columbia
city: Aventura
country: United States
facility: Palatin Clinical Site 204
state: Florida
city: Coral Gables
country: United States
facility: Palatin Clinical Site 273
state: Florida
city: Fort Myers
country: United States
facility: Palatin Clinical Site 203
state: Florida
city: Gainesville
country: United States
facility: Palatin Clinical Site 255
state: Florida
city: Gainesville
country: United States
facility: Palatin Clinical Site 266
state: Florida
city: Jupiter
country: United States
facility: Palatin Clinical Site 224
state: Florida
city: Orlando
country: United States
facility: Palatin Clinical Site 250
state: Florida
city: Oviedo
country: United States
facility: Palatin Clinical Site 261
state: Florida
city: Pinellas Park
country: United States
facility: Palatin Clinical Site 260
state: Florida
city: West Palm Beach
country: United States
facility: Palatin Clinical Site 236
state: Florida
city: Alpharetta
country: United States
facility: Palatin Clinical Site 248
state: Georgia
city: Atlanta
country: United States
facility: Palatin Clinical Site 263
state: Georgia
city: Addison
country: United States
facility: Palatin Clinical Site 288
state: Illinois
city: Chicago
country: United States
facility: Palatin Clinical Site 252
state: Illinois
city: Chicago
country: United States
facility: Palatin Clinical Site 201
state: Illinois
city: Indianapolis
country: United States
facility: Palatin Clinical Site 277
state: Indiana
city: Prairie Village
country: United States
facility: Palatin Clinical Site 247
state: Kansas
city: Paducah
country: United States
facility: Palatin Clinical Site 286
state: Kentucky
city: Lake Charles
country: United States
facility: Palatin Clinical Site 279
state: Louisiana
city: Metairie
country: United States
facility: Palatin Clinical Site 281
state: Louisiana
city: Annapolis
country: United States
facility: Palatin Clinical Site 257
state: Maryland
city: Lutherville
country: United States
facility: Palatin Clinical Site 222
state: Maryland
city: Rockville
country: United States
facility: Palatin Clinical Site 283
state: Maryland
city: Boston
country: United States
facility: Palatin Clinical Site 265
state: Massachusetts
city: New Bedford
country: United States
facility: Palatin Clinical Site 217
state: Massachusetts
city: Kalamazoo
country: United States
facility: Palatin Clinical Site 239
state: Michigan
city: Saginaw
country: United States
facility: Palatin Clinical Site 245
state: Michigan
city: Flowood
country: United States
facility: Palatin Clinical Site 287
state: Mississippi
city: Kansas City
country: United States
facility: Palatin Clinical Site 244
state: Missouri
city: Saint Louis
country: United States
facility: Palatin Clinical Site 280
state: Missouri
city: Lincoln
country: United States
facility: Palatin Clinical Site 220
state: Nebraska
city: Berlin
country: United States
facility: Palatin Clinical Site 290
state: New Jersey
city: Lawrenceville
country: United States
facility: Palatin Clinical Site 233
state: New Jersey
city: Albuquerque
country: United States
facility: Palatin Clinical Site 276
state: New Mexico
city: Rochester
country: United States
facility: Palatin Clinical Site 282
state: New York
city: Cary
country: United States
facility: Palatin Clinical Site 264
state: North Carolina
city: Raleigh
country: United States
facility: Palatin Clinical Site 206
state: North Carolina
city: Salisbury
country: United States
facility: Palatin Clinical Site 231
state: North Carolina
city: Winston-Salem
country: United States
facility: Palatin Clinical Site 209
state: North Carolina
city: Canton
country: United States
facility: Palatin Clinical Site 271
state: Ohio
city: Cincinnati
country: United States
facility: Palatin Clinical Site 215
state: Ohio
city: Cleveland
country: United States
facility: Palatin Clinical Site 232
state: Ohio
city: Columbus
country: United States
facility: Palatin Clinical Site 246
state: Ohio
city: Mayfield Heights
country: United States
facility: Palatin Clinical Site 221
state: Ohio
city: Tiffin
country: United States
facility: Palatin Clinical Site 289
state: Ohio
city: Oklahoma City
country: United States
facility: Palatin Clinical Site 238
state: Oklahoma
city: Oklahoma City
country: United States
facility: Palatin Clinical Site 227
state: Oklahoma
city: Allentown
country: United States
facility: Palatin Clinical Site 267
state: Pennsylvania
city: Philadelphia
country: United States
facility: Palatin Clinical Site 234
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Palatin Clinical Site 240
state: Pennsylvania
city: Lincoln
country: United States
facility: Palatin Clinical Site 278
state: Rhode Island
city: Greer
country: United States
facility: Palatin Clinical Site 200
state: South Carolina
city: Moncks Corner
country: United States
facility: Palatin Clinical Site 259
state: South Carolina
city: Chattanooga
country: United States
facility: Palatin Clinical Site 275
state: Tennessee
city: Jackson
country: United States
facility: Palatin Clinical Site 216
state: Tennessee
city: Memphis
country: United States
facility: Palatin Clinical Site 274
state: Tennessee
city: Nashville
country: United States
facility: Palatin Clinical Site 292
state: Tennessee
city: Arlington
country: United States
facility: Palatin Clinical Site 235
state: Texas
city: Austin
country: United States
facility: Palatin Clinical Site 230
state: Texas
city: Dallas
country: United States
facility: Palatin Clinical Site 223
state: Texas
city: Houston
country: United States
facility: Palatin Clinical Site 208
state: Texas
city: Draper
country: United States
facility: Palatin Clinical Site 269
state: Utah
city: West Jordan
country: United States
facility: Palatin Clinical Site 228
state: Utah
city: Newport News
country: United States
facility: Palatin Clinical Site 284
state: Virginia
city: Norfolk
country: United States
facility: Palatin Clinical Site 205
state: Virginia
city: Richmond
country: United States
facility: Palatin Clinical Site 213
state: Virginia
city: Richmond
country: United States
facility: Palatin Clinical Site 268
state: Virginia
city: Seattle
country: United States
facility: Palatin Clinical Site 214
state: Washington
city: Charleston
country: United States
facility: Palatin Clinical Site 285
state: West Virginia
city: Vancouver
country: Canada
facility: Palatin Clinical Site 400
state: British Columbia
city: Sudbury
country: Canada
facility: Palatin Clinical Site 405
state: Ontario
city: Pointe Claire
country: Canada
facility: Palatin Clinical Site 401
state: Quebec
city: Sherbrooke
country: Canada
facility: Palatin Clinical Site 404
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.