2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder

Phase 3

Completed

Conditions: Hypoactive Sexual Desire Disorder

Interventions: Drug: Bremelanotide
Drug: Placebo

Registration Number: NCT02338960

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: 714

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

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
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
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

Primary Outcome Measures

Name	Time	Method
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 (item 13). Responses range from 0 (never) to 4 (always). Lower scores on this scale represent an increase in sexual desire and indicate a better outcome. Higher scores indicate a worse outcome.
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 This score is on a scale ranging from 1.2 to 6. A higher score on this scale represent an increase in sexual desire and is a better outcome.

Secondary Outcome Measures

Name	Time	Method
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	8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)	Mean change from Baseline to end of study (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 indicates a better outcome.
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	8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)	FSEP-R=Female Sexual Encounter Profile - Revised Scores range from 0 (no desire) to 3 (high desire). Scale is derived from a questionnaire (mean desire score) where a higher score indicates a better outcome.
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	24 weeks (Main Study)	Mean change from Baseline to EOS in the number of satisfying sexual events SSEs associated with study drug administration throughout the entirety of the double-blind phase. A higher number of events indicates a better outcome.
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	8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)	FSEP-R=Female Sexual Encounter Profile - Revised Scores on this scale range from 0 (no desire) to 3 (high desire) Scale is derived from a questionnaire (mean desire score) where a higher score indicates a better outcome.
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)	8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)	Female Sexual Function Index (FSFI) The score is computed programmatically using the algorithm described by Rosen, resulting in a score ranging from 1.2 to 6. Higher 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 the Change in 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. A higher number of events indicates a better outcome.
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	8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)	FSEP-R=Female Sexual Encounter Profile - Revised Scores on this scale range from 0 (no desire) to 3 (high desire). Scale is derived from a questionnaire (mean desire score) where an increase in value indicates a better outcome.
Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in 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. The FSDS-DAO is a validated 15-item self-assessment of sexual feelings and problems. All responses are on a scale ranging from 0 ("never") to 4 ("always"). Total Scores range from 0 (never feel bothered) to 60 (always feel bothered). Decreased scores indicate improvement. A higher score on this scale indicates a worse outcome. The score is the mean change from Baseline observed at EOS (Baseline score - EOS score)
Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the FSFI Total Score	8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)	Female Sexual Function Index (FSFI) The score is computed programmatically \] resulting in a score on a scale ranging from 1.2 to 6 (Note: OLE: Open-label extension. Scores range from 2 to 36. An improvement in total FSFI score is an increase from baseline. A higher score on this scale represents an increase in sexual desire and is a better outcome.
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	8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)	FSEP-R=Female Sexual Encounter Profile - Revised Scores range from 0 (no desire) to 3 (high desire) Scale is derived from a questionnaire (mean desire score) where a higher score indicates a better outcome.
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	8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)	FSDS-DAO = Female Sexual Distress Scale - Desire/Arousal/Orgasm. The FSDS-DAO is a validated 15-item self-assessment of sexual feelings and problems. Scores on this scale range from 0 ("never") to 4 ("always"). Decreased scores indicate improvement. A higher score on this scale indicates a worse outcome.
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	24 weeks (Main Study)	FSFI = Female Sexual Function Index The score is on a scale ranging from 1.2 to 6. A higher score on this scale represents an increase in sexual desire and is a better outcome.
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	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"). Decreased scores indicate improvement. A higher score indicates a worse outcome.

Trial Locations

Locations (91): Palatin Clinical Site 263
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Atlanta, Georgia, United States
Palatin Clinical Site 204
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Aventura, Florida, United States
Palatin Clinical Site 285
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Charleston, West Virginia, United States
Palatin Clinical Site 404
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Sherbrooke, Quebec, Canada
Palatin Clinical Site 206
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Raleigh, North Carolina, United States
Palatin Clinical Site 275
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Chattanooga, Tennessee, United States
Palatin Clinical Site 223
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Dallas, Texas, United States
Palatin Clinical Site 201
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Chicago, Illinois, United States
Palatin Clinical Site 265
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Boston, Massachusetts, United States
Palatin Clinical Site 232
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Cleveland, Ohio, United States
Palatin Clinical Site 246
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Columbus, Ohio, United States
Palatin Clinical Site 240
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Pittsburgh, Pennsylvania, United States
Palatin Clinical Site 222
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Lutherville, Maryland, United States
Palatin Clinical Site 283
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Rockville, Maryland, United States
Palatin Clinical Site 277
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Indianapolis, Indiana, United States
Palatin Clinical Site 214
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Seattle, Washington, United States
Palatin Clinical Site 400
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Vancouver, British Columbia, Canada
Palatin Clinical Site 218
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Phoenix, Arizona, United States
Palatin Clinical Site 227
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Oklahoma City, Oklahoma, United States
Palatin Clinical Site 292
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Nashville, Tennessee, United States
Palatin Clinical Site 242
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Birmingham, Alabama, United States
Palatin Clinical Site 243
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Lakewood, Colorado, United States
Palatin Clinical Site 229
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Waterbury, Connecticut, United States
Palatin Clinical Site 251
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San Diego, California, United States
Palatin Clinical Site 207
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Hot Springs, Arkansas, United States
Palatin Clinical Site 210
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San Diego, California, United States
Palatin Clinical Site 238
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Oklahoma City, Oklahoma, United States
Palatin Clinical Site 200
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Greer, South Carolina, United States
Palatin Clinical Site 252
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Chicago, Illinois, United States
Palatin Clinical Site 261
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Oviedo, Florida, United States
Palatin Clinical Site 266
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Gainesville, Florida, United States
Palatin Clinical Site 279
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Lake Charles, Louisiana, United States
Palatin Clinical Site 234
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Philadelphia, Pennsylvania, United States
Palatin Clinical Site 220
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Lincoln, Nebraska, United States
Palatin Clinical Site 259
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Moncks Corner, South Carolina, United States
Palatin Clinical Site 405
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Sudbury, Ontario, Canada
Palatin Clinical Site 401
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Pointe Claire, Quebec, Canada
Palatin Clinical Site 212
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Denver, Colorado, United States
Palatin Clinical Site 219
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Denver, Colorado, United States
Palatin Clinical Site 274
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Memphis, Tennessee, United States
Palatin Clinical Site 256
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Garden Grove, California, United States
Palatin Clinical Site 254
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Tucson, Arizona, United States
Palatin Clinical Site 258
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Beverly Hills, California, United States
Palatin Clinical Site 291
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Los Angeles, California, United States
Palatin Clinical Site 270
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Oakland, California, United States
Palatin Clinical Site 272
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Sherman Oaks, California, United States
Palatin Clinical Site 253
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Tarzana, California, United States
Palatin Clinical Site 211
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New London, Connecticut, United States
Palatin Clinical Site 202
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Washington, District of Columbia, United States
Palatin Clinical Site 273
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Coral Gables, Florida, United States
Palatin Clinical Site 203
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Fort Myers, Florida, United States
Palatin Clinical Site 255
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Gainesville, Florida, United States
Palatin Clinical Site 250
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Orlando, Florida, United States
Palatin Clinical Site 224
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Jupiter, Florida, United States
Palatin Clinical Site 260
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Pinellas Park, Florida, United States
Palatin Clinical Site 248
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Alpharetta, Georgia, United States
Palatin Clinical Site 236
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West Palm Beach, Florida, United States
Palatin Clinical Site 288
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Addison, Illinois, United States
Palatin Clinical Site 247
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Prairie Village, Kansas, United States
Palatin Clinical Site 286
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Paducah, Kentucky, United States
Palatin Clinical Site 281
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Metairie, Louisiana, United States
Palatin Clinical Site 257
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Annapolis, Maryland, United States
Palatin Clinical Site 245
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Saginaw, Michigan, United States
Palatin Clinical Site 239
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Kalamazoo, Michigan, United States
Palatin Clinical Site 217
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New Bedford, Massachusetts, United States
Palatin Clinical Site 287
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Flowood, Mississippi, United States
Palatin Clinical Site 244
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Kansas City, Missouri, United States
Palatin Clinical Site 290
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Berlin, New Jersey, United States
Palatin Clinical Site 280
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Saint Louis, Missouri, United States
Palatin Clinical Site 233
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Lawrenceville, New Jersey, United States
Palatin Clinical Site 276
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Albuquerque, New Mexico, United States
Palatin Clinical Site 282
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Rochester, New York, United States
Palatin Clinical Site 264
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Cary, North Carolina, United States
Palatin Clinical Site 231
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Salisbury, North Carolina, United States
Palatin Clinical Site 271
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Canton, Ohio, United States
Palatin Clinical Site 209
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Winston-Salem, North Carolina, United States
Palatin Clinical Site 215
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Cincinnati, Ohio, United States
Palatin Clinical Site 267
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Allentown, Pennsylvania, United States
Palatin Clinical Site 221
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Mayfield Heights, Ohio, United States
Palatin Clinical Site 289
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Tiffin, Ohio, United States
Palatin Clinical Site 278
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Lincoln, Rhode Island, United States
Palatin Clinical Site 216
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Jackson, Tennessee, United States
Palatin Clinical Site 235
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Arlington, Texas, United States
Palatin Clinical Site 230
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Austin, Texas, United States
Palatin Clinical Site 208
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Houston, Texas, United States
Palatin Clinical Site 269
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Draper, Utah, United States
Palatin Clinical Site 228
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West Jordan, Utah, United States
Palatin Clinical Site 213
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Richmond, Virginia, United States
Palatin Clinical Site 284
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Newport News, Virginia, United States
Palatin Clinical Site 205
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Norfolk, Virginia, United States
Palatin Clinical Site 268
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Richmond, Virginia, United States