1. 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: Other: 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): 723
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B35 1M7
      • Palatin Clinical Site 304
    • Kentville, Nova Scotia, Canada, B4N 4K9
      • Palatin Clinical Site 303
  • Ontario
    • Toronto, Ontario, Canada, M9W 4L6
      • Palatin Clinical Site 301
  • Quebec
    • Saint Romuald, Quebec, Canada, G6W 5M6
      • Palatin Clinical Site 302
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35211
      • Palatin Clinical Site 121
    • Huntsville, Alabama, United States, 35801
      • Palatin Clinical Site 110
    • Mobile, Alabama, United States, 36608
      • Palatin Clinical Site 106
  • Arizona
    • Scottsdale, Arizona, United States, 85251
      • Palatin Clinical Site 149
    • Tucson, Arizona, United States, 85712
      • Palatin Clinical Site 157
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Palatin Clinical Site 166
  • California
    • National City, California, United States, 91950
      • Palatin Clinical Site 102
    • Oceanside, California, United States, 92056
      • Palatin Clinical Site 164
    • Orange, California, United States, 92868
      • Palatin Clinical Site 152
    • Sacramento, California, United States, 95821
      • Palatin Clinical Site 188
    • San Diego, California, United States, 92103
      • Palatin Clinical Site 141
    • Walnut Creek, California, United States, 94598
      • Palatin Clinical Site 187
  • Colorado
    • Centennial, Colorado, United States, 80239
      • Palatin Clinical Site 160
    • Colorado Springs, Colorado, United States, 80907
      • Palatin Clinical Site 185
  • Florida
    • Bradenton, Florida, United States, 34208
      • Palatin Clinical Site 130
    • Hollywood, Florida, United States, 33024
      • Palatin Clinical Site 128
    • Jacksonville, Florida, United States, 32256
      • Palatin Clinical Site 134
    • Melbourne, Florida, United States, 32934
      • Palatin Clinical Site 108
    • Orlando, Florida, United States, 32801
      • Palatin Clinical Site 105
    • Saint Petersburg, Florida, United States, 33709
      • Palatin Clinical Site 144
    • South Miami, Florida, United States, 33143
      • Palatin Clinical Site 131
    • West Palm Beach, Florida, United States, 33401
      • Palatin Clinical Site 101
  • Georgia
    • Decatur, Georgia, United States, 30030
      • Palatin Clinical Site 116
    • Savannah, Georgia, United States, 31406
      • Palatin Clinical Site 142
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Palatin Clinical Site 171
  • Indiana
    • Evansville, Indiana, United States, 47710
      • Palatin Clinical Site 179
    • Lafayette, Indiana, United States, 47905
      • Palatin Clinical Site 165
    • Mishawaka, Indiana, United States, 46545
      • Palatin Clinical Site 154
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Palatin Clinical Site 184
  • Kansas
    • Overland Park, Kansas, United States, 66202
      • Palatin Clinical Site 155
    • Wichita, Kansas, United States, 67211
      • Palatin Clinical Site 104
  • Kentucky
    • Louisville, Kentucky, United States, 40291
      • Palatin Clinical Site 191
  • Louisiana
    • Eunice, Louisiana, United States, 70535
      • Palatin Clinical Site 194
    • New Orleans, Louisiana, United States, 70119
      • Palatin Clinical Site 186
  • Maine
    • Bangor, Maine, United States, 04401
      • Palatin Clinical Site 183
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Palatin Clinical Site 159
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Palatin Clinical Site 119
    • Watertown, Massachusetts, United States, 02472
      • Palatin Clinical Site 126
  • Michigan
    • Bingham Farms, Michigan, United States, 48025
      • Palatin Clinical Site 163
    • Rochester, Michigan, United States, 48307
      • Palatin Clinical Site 181
  • Mississippi
    • Olive Branch, Mississippi, United States, 38654
      • Palatin Clinical Site 182
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Palatin Clinical Site 170
  • Montana
    • Billings, Montana, United States, 59102
      • Palatin Clinical Site 180
  • Nebraska
    • Norfolk, Nebraska, United States, 68701
      • Palatin Clinical Site 192
    • Omaha, Nebraska, United States, 68114
      • Palatin Clinical Site 168
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Palatin Clinical Site 111
    • Las Vegas, Nevada, United States, 89119
      • Palatin Clinical Site 125
    • Las Vegas, Nevada, United States, 89128
      • Palatin Clinical Site 109
    • Las Vegas, Nevada, United States, 89128
      • Palatin Clinical Site 195
  • New Jersey
    • Moorestown, New Jersey, United States, 08057
      • Palatin Clinical Site 120
    • Plainsboro, New Jersey, United States, 08536
      • Palatin Clinical Site 123
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Palatin Clinical Site 124
  • New York
    • Johnson City, New York, United States, 13790
      • Palatin Clinical Site 189
    • New York, New York, United States, 10016
      • Palatin Clinical Site 107
    • Port Jefferson, New York, United States, 11777
      • Palatin Clinical Site 158
    • Poughkeepsie, New York, United States, 12601
      • Palatin Clinical Site 127
    • Rochester, New York, United States, 14609
      • Palatin Clinical Site 190
  • North Carolina
    • Charlotte, North Carolina, United States, 28209
      • Palatin Clinical Site 137
    • Winston-Salem, North Carolina, United States, 27103
      • Palatin Clinical Site 135
    • Winston-Salem, North Carolina, United States, 27103
      • Palatin Clinical Site 156
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Palatin Clinical Site 139
  • Ohio
    • Akron, Ohio, United States, 44311
      • Palatin Clinical Site 140
    • Beachwood, Ohio, United States, 44122
      • Palatin Clinical Site 122
    • Cincinnati, Ohio, United States, 45227
      • Palatin Clinical Site 151
    • Columbus, Ohio, United States, 43213
      • Palatin Clinical Site 112
    • Englewood, Ohio, United States, 45322
      • Palatin Clinical Site 115
  • Oregon
    • Medford, Oregon, United States, 97504
      • Palatin Clinical Site 132
    • Portland, Oregon, United States, 97210
      • Palatin Clinical Site 146
  • Pennsylvania
    • Jenkintown, Pennsylvania, United States, 19046
      • Palatin Clinical Site 169
    • Media, Pennsylvania, United States, 19063
      • Palatin Clinical Site 172
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Palatin Clinical Site 117
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Palatin Clinical Site 162
    • Bluffton, South Carolina, United States, 29910
      • Palatin Clinical Site 143
    • Mount Pleasant, South Carolina, United States, 29464
      • Palatin Clinical Site 114
    • Mount Pleasant, South Carolina, United States, 29464
      • Palatin Clinical Site 145
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Palatin Clinical Site 161
    • Nashville, Tennessee, United States, 37203
      • Palatin Clinical Site 129
  • Texas
    • Bryan, Texas, United States, 77802
      • Palatin Clinical Site 174
    • Dallas, Texas, United States, 75231
      • Palatin Clinical Site 113
    • San Antonio, Texas, United States, 78229
      • Palatin Clinical Site 118
    • Sugar Land, Texas, United States, 77479
      • Palatin Clinical Site 176
  • Utah
    • Murray, Utah, United States, 84123
      • Palatin Clinical Site 100
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Palatin Clinical Site 103
    • Virginia Beach, Virginia, United States, 23456
      • Palatin Clinical Site 138
  • Washington
    • Spokane, Washington, United States, 99207
      • Palatin Clinical Site 133
    • Tacoma, Washington, United States, 98405
      • Palatin Clinical Site 150
  • Wisconsin
    • Middleton, Wisconsin, United States, 53562
      • Palatin Clinical Site 193

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	Other: 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. FSFI = Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. Its six subscales assess desire, arousal, lubrication, orgasm, satisfaction, and pain, by summing individual items that comprise the subscale and multiplying the sum by a factor, resulting in a score ranging from 1.2 to 6. Increasing scores on this scale represent an increase in sexual desire and is a positive 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 (Female Sexual Distress Scale - Desire Arousal Orgasm) (item 13).: co-primary endpoint - FSDS-DAO bothered by low desire item 13. Responses range from 0 (never) to 4 (always). Decreasing scores on this scale represent an increase in sexual desire (positive 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 in the Number of Satisfying Sexual Events (SSEs) Associated With Study Drug Administration	Patient's change, from baseline to end of study (EOS), in the number of Satisfying Sexual Events (SSEs), as measured by a response of 'Yes' to question 10 (Q10) of the Female Sexual Encounter Profile-Revised questionnaire (FSEP-R). The end point was calculated as the number of events during the last 4 weeks of treatment with Q10 = Yes minus the number of baseline events with Q10 = Yes.	8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
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	Scores range from 0 (no desire) to 3 (high desire) for an individual encounter. Change from baseline is computed as the mean of the scores from all encounters for a subject in the last 28 days minus the mean of the scores from all encounters for the subject in the last 28 days before Visit 3. Only FSEP-R data pertaining to encounters recorded within 72 hours of the encounter are included.	8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
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	Patient's change, from baseline to end of study (EOS), in mean satisfaction with desire score, as measured by a response to question 4 (Q4) of the Female Sexual Encounter Profile-Revised questionnaire (FSEP-R). Responses range from 1 (Not at all satisfied) to 4 (Completely satisfied).	8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the FSDS-DAO Total Score	FSDS-DAO = Female Sexual Distress Scale - Desire/Arousal/Orgasm Scores range from 0 (never feel bothered) to 60 (always feel bothered).	8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Total FSFI Total Score	FSFI = Female Sexual Function Index: a multidimensional self-report instrument for the assessment of female sexual function. The FSFI total score is on a scale ranging from 2 to 36. Increasing scores on this scale represent an increase in sexual desire and is a positive outcome.	8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
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	FSEP-R=Female Sexual Encounter Profile - Revised Scores range from 0 (not at all aroused) to 3 (highly aroused) for an individual encounter. 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 a Change From 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 (not at all aroused) to 3 (highly aroused) for an individual encounter. 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 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	FSDS-DAO = Female Sexual Distress Scale-Desire/Arousal/Orgasm. The outcome reported is the mean score from the 15-item self assessment. The result is on a scale ranging from 0 ("never") to 4 ("always"). A higher score 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 a Change From Baseline to End of Study in the Arousal Domain of the FSFI (Q3 to Q6)	FSFI = Female Sexual Function Index: a multidimensional self-report instrument for the assessment of female sexual function. The score is on a scale ranging from 1.2 to 6. Increasing 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 a Change From 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 that occurred within 16 hours of a study drug dosing and reported within 72 hours. A higher 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 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	FSFI = Female Sexual Function Index: a multidimensional self-report instrument for the assessment of female sexual function. The score is on a scale ranging from 1.2 to 6. Increasing scores on this scale represent an increase in sexual desire and is a positive outcome.	24 weeks (Main Study)
Change From Baseline to End of Study in the Total Score for 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"). A higher score indicates a worse outcome. The score is the mean change from Baseline observed at EOS (Baseline score - EOS score) for FSDS-DAO Item 13 (feeling bothered by low sexual desire).	24 weeks (Main Study)
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	Mean change from Baseline to 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 reflects a positive outcome.	24 weeks (Main Study)

Collaborators and Investigators

• Sponsor: Palatin Technologies, 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: December 1, 2014
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: December 28, 2014
• First Submitted That Met QC Criteria: January 6, 2015
• First Posted (Estimate): January 7, 2015

Study Record Updates

• Last Update Posted (Actual): April 9, 2021
• Last Update Submitted That Met QC Criteria: March 16, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: HSDD; Female Sexual Desire Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Disease; Hypokinesia; Sexual Dysfunctions, Psychological
• Other Study ID Numbers: BMT-301; Reconnect Study (Other Identifier: Palatin Technologies)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No