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

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)

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.

Study Overview

• Status: Completed
• Conditions: Hypoactive Sexual Desire Disorder
• Intervention / Treatment: Drug: Placebo; Drug: Bremelanotide

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.

• Study Type: Interventional
• Enrollment (Actual): 714
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6J 1S3
      • Palatin Clinical Site 400
  • Ontario
    • Sudbury, Ontario, Canada, P3E 1H5
      • Palatin Clinical Site 405
  • Quebec
    • Pointe Claire, Quebec, Canada, H9R 4S3
      • Palatin Clinical Site 401
    • Sherbrooke, Quebec, Canada, J1H 121
      • Palatin Clinical Site 404
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35242
      • Palatin Clinical Site 242
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Palatin Clinical Site 218
    • Tucson, Arizona, United States, 85712
      • Palatin Clinical Site 254
  • Arkansas
    • Hot Springs, Arkansas, United States, 71901
      • Palatin Clinical Site 207
  • California
    • Beverly Hills, California, United States, 90210
      • Palatin Clinical Site 258
    • Garden Grove, California, United States, 92845
      • Palatin Clinical Site 256
    • Los Angeles, California, United States, 90024
      • Palatin Clinical Site 291
    • Oakland, California, United States, 94612
      • Palatin Clinical Site 270
    • San Diego, California, United States, 92120
      • Palatin Clinical Site 210
    • San Diego, California, United States, 92123
      • Palatin Clinical Site 251
    • Sherman Oaks, California, United States, 91403
      • Palatin Clinical Site 272
    • Tarzana, California, United States, 91356
      • Palatin Clinical Site 253
  • Colorado
    • Denver, Colorado, United States, 80209
      • Palatin Clinical Site 212
    • Denver, Colorado, United States, 80220
      • Palatin Clinical Site 219
    • Lakewood, Colorado, United States, 80228
      • Palatin Clinical Site 243
  • Connecticut
    • New London, Connecticut, United States, 06320
      • Palatin Clinical Site 211
    • Waterbury, Connecticut, United States, 06708
      • Palatin Clinical Site 229
  • District of Columbia
    • Washington, District of Columbia, United States, 20036
      • Palatin Clinical Site 202
  • Florida
    • Aventura, Florida, United States, 33180
      • Palatin Clinical Site 204
    • Coral Gables, Florida, United States, 33134
      • Palatin Clinical Site 273
    • Fort Myers, Florida, United States, 33912
      • Palatin Clinical Site 203
    • Gainesville, Florida, United States, 32607
      • Palatin Clinical Site 255
    • Gainesville, Florida, United States, 32607
      • Palatin Clinical Site 266
    • Jupiter, Florida, United States, 33458
      • Palatin Clinical Site 224
    • Orlando, Florida, United States, 32806
      • Palatin Clinical Site 250
    • Oviedo, Florida, United States, 32765
      • Palatin Clinical Site 261
    • Pinellas Park, Florida, United States, 33781
      • Palatin Clinical Site 260
    • West Palm Beach, Florida, United States, 33409
      • Palatin Clinical Site 236
  • Georgia
    • Alpharetta, Georgia, United States, 30005
      • Palatin Clinical Site 248
    • Atlanta, Georgia, United States, 30328
      • Palatin Clinical Site 263
  • Illinois
    • Addison, Illinois, United States, 60101
      • Palatin Clinical Site 288
    • Chicago, Illinois, United States, 60640
      • Palatin Clinical Site 252
    • Chicago, Illinois, United States, 60654
      • Palatin Clinical Site 201
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Palatin Clinical Site 277
  • Kansas
    • Prairie Village, Kansas, United States, 66206
      • Palatin Clinical Site 247
  • Kentucky
    • Paducah, Kentucky, United States, 42003
      • Palatin Clinical Site 286
  • Louisiana
    • Lake Charles, Louisiana, United States, 70629
      • Palatin Clinical Site 279
    • Metairie, Louisiana, United States, 70002
      • Palatin Clinical Site 281
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Palatin Clinical Site 257
    • Lutherville, Maryland, United States, 21093
      • Palatin Clinical Site 222
    • Rockville, Maryland, United States, 20852
      • Palatin Clinical Site 283
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Palatin Clinical Site 265
    • New Bedford, Massachusetts, United States, 02740
      • Palatin Clinical Site 217
  • Michigan
    • Kalamazoo, Michigan, United States, 49009
      • Palatin Clinical Site 239
    • Saginaw, Michigan, United States, 48604
      • Palatin Clinical Site 245
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Palatin Clinical Site 287
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • Palatin Clinical Site 244
    • Saint Louis, Missouri, United States, 63043
      • Palatin Clinical Site 280
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Palatin Clinical Site 220
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Palatin Clinical Site 290
    • Lawrenceville, New Jersey, United States, 08648
      • Palatin Clinical Site 233
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Palatin Clinical Site 276
  • New York
    • Rochester, New York, United States, 14618
      • Palatin Clinical Site 282
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • Palatin Clinical Site 264
    • Raleigh, North Carolina, United States, 27612
      • Palatin Clinical Site 206
    • Salisbury, North Carolina, United States, 28144
      • Palatin Clinical Site 231
    • Winston-Salem, North Carolina, United States, 27103
      • Palatin Clinical Site 209
  • Ohio
    • Canton, Ohio, United States, 44718
      • Palatin Clinical Site 271
    • Cincinnati, Ohio, United States, 45249
      • Palatin Clinical Site 215
    • Cleveland, Ohio, United States, 44122
      • Palatin Clinical Site 232
    • Columbus, Ohio, United States, 43212
      • Palatin Clinical Site 246
    • Mayfield Heights, Ohio, United States, 44124
      • Palatin Clinical Site 221
    • Tiffin, Ohio, United States, 44883
      • Palatin Clinical Site 289
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • Palatin Clinical Site 238
    • Oklahoma City, Oklahoma, United States, 73112
      • Palatin Clinical Site 227
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Palatin Clinical Site 267
    • Philadelphia, Pennsylvania, United States, 19114
      • Palatin Clinical Site 234
    • Pittsburgh, Pennsylvania, United States, 15206
      • Palatin Clinical Site 240
  • Rhode Island
    • Lincoln, Rhode Island, United States, 02865
      • Palatin Clinical Site 278
  • South Carolina
    • Greer, South Carolina, United States, 29650
      • Palatin Clinical Site 200
    • Moncks Corner, South Carolina, United States, 29461
      • Palatin Clinical Site 259
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Palatin Clinical Site 275
    • Jackson, Tennessee, United States, 38305
      • Palatin Clinical Site 216
    • Memphis, Tennessee, United States, 38119
      • Palatin Clinical Site 274
    • Nashville, Tennessee, United States, 37201
      • Palatin Clinical Site 292
  • Texas
    • Arlington, Texas, United States, 75230
      • Palatin Clinical Site 235
    • Austin, Texas, United States, 78731
      • Palatin Clinical Site 230
    • Dallas, Texas, United States, 75234
      • Palatin Clinical Site 223
    • Houston, Texas, United States, 77054
      • Palatin Clinical Site 208
  • Utah
    • Draper, Utah, United States, 84020
      • Palatin Clinical Site 269
    • West Jordan, Utah, United States, 84088
      • Palatin Clinical Site 228
  • Virginia
    • Newport News, Virginia, United States, 23606
      • Palatin Clinical Site 284
    • Norfolk, Virginia, United States, 23502
      • Palatin Clinical Site 205
    • Richmond, Virginia, United States, 23294
      • Palatin Clinical Site 213
    • Richmond, Virginia, United States, 23298
      • Palatin Clinical Site 268
  • Washington
    • Seattle, Washington, United States, 98105
      • Palatin Clinical Site 214
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • Palatin Clinical Site 285

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Bremelanotide; A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone); Other Names: BMT; PT-141
Placebo Comparator: 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	Drug: Placebo; Placebo; Other Names: PBO; Drug: Bremelanotide; A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone); Other Names: BMT; PT-141

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of a Fixed Dose of Bremelanotide as Measured by FSFI (Question Q1 and Q2), 28-day Recall.	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.	8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Efficacy of a Fixed Dose of Bremelanotide as Measured by FSDS-DAO (Item 13)	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.	8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
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	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.	8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
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	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.	8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the FSDS-DAO Total Score	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)	8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the FSFI Total Score	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.	8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
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	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.	8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
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	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.	8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
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	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.	8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
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)	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.	8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Total Number of SSEs	Change from Baseline to EOS in the total number of satisfying sexual events SSEs. A higher number of events indicates a better outcome.	8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
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	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.	24 weeks (Main Study)
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	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.	24 weeks (Main Study)
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	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.	24 weeks (Main Study)

Collaborators and Investigators

• Sponsor: Palatin Technologies, Inc
• Collaborators: AMAG Pharmaceuticals, Inc.
• Investigators: Study Director: Robert Jordan, Palatin Technologies, Inc

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): June 29, 2017

Study Registration Dates

• First Submitted: January 12, 2015
• First Submitted That Met QC Criteria: January 14, 2015
• First Posted (Estimate): January 15, 2015

Study Record Updates

• Last Update Posted (Actual): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: female sexual dysfunction; Sexual Desire Disorder; HSDD Female; decreased desire
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Disease; Hypokinesia; Sexual Dysfunctions, Psychological
• Other Study ID Numbers: BMT-302; Reconnect Study (Other Identifier: Palatin Technologies)