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

NCT02333071 | Completed Phase 3 Results DMC

• 2 other identifiers: BMT-301Reconnect Study
• Study Type: interventional
• Target: 723
• Locations: 2 countries
• Sites: 91

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.

Conditions

Hypoactive Sexual Desire Disorder

Keywords

HSDD; Female Sexual Desire Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• 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

  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

  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

  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

  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

  8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

Study Arms (2)

Bremelanotide (BMT/BMT)

EXPERIMENTAL

(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

Placebo (PBO/BMT)

PLACEBO COMPARATOR

(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: Bremelanotide; Other: Placebo

Interventions

Bremelanotide DRUG

A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)

Also known as: BMT, PT-141

Bremelanotide (BMT/BMT); Placebo (PBO/BMT)

Placebo OTHER

Placebo

Also known as: PBO

Placebo (PBO/BMT)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Palatin Technologies, Inc: lead

Study Sites (91)

Palatin Clinical Site 121

Birmingham, Alabama, 35211, United States

Location

Palatin Clinical Site 110

Huntsville, Alabama, 35801, United States

Location

Palatin Clinical Site 106

Mobile, Alabama, 36608, United States

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Palatin Clinical Site 149

Scottsdale, Arizona, 85251, United States

Location

Palatin Clinical Site 157

Tucson, Arizona, 85712, United States

Location

Palatin Clinical Site 166

Little Rock, Arkansas, 72205, United States

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Palatin Clinical Site 102

National City, California, 91950, United States

Location

Palatin Clinical Site 164

Oceanside, California, 92056, United States

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Palatin Clinical Site 152

Orange, California, 92868, United States

Location

Palatin Clinical Site 188

Sacramento, California, 95821, United States

Location

Palatin Clinical Site 141

San Diego, California, 92103, United States

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Palatin Clinical Site 187

Walnut Creek, California, 94598, United States

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Palatin Clinical Site 160

Centennial, Colorado, 80239, United States

Location

Palatin Clinical Site 185

Colorado Springs, Colorado, 80907, United States

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Palatin Clinical Site 130

Bradenton, Florida, 34208, United States

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Palatin Clinical Site 128

Hollywood, Florida, 33024, United States

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Palatin Clinical Site 134

Jacksonville, Florida, 32256, United States

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Palatin Clinical Site 108

Melbourne, Florida, 32934, United States

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Palatin Clinical Site 105

Orlando, Florida, 32801, United States

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Palatin Clinical Site 131

South Miami, Florida, 33143, United States

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Palatin Clinical Site 144

St. Petersburg, Florida, 33709, United States

Location

Palatin Clinical Site 101

West Palm Beach, Florida, 33401, United States

Location

Palatin Clinical Site 116

Decatur, Georgia, 30030, United States

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Palatin Clinical Site 142

Savannah, Georgia, 31406, United States

Location

Palatin Clinical Site 171

Meridian, Idaho, 83642, United States

Location

Palatin Clinical Site 179

Evansville, Indiana, 47710, United States

Location

Palatin Clinical Site 165

Lafayette, Indiana, 47905, United States

Location

Palatin Clinical Site 154

Mishawaka, Indiana, 46545, United States

Location

Palatin Clinical Site 184

West Des Moines, Iowa, 50266, United States

Location

Palatin Clinical Site 155

Overland Park, Kansas, 66202, United States

Location

Palatin Clinical Site 104

Wichita, Kansas, 67211, United States

Location

Palatin Clinical Site 191

Louisville, Kentucky, 40291, United States

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Palatin Clinical Site 194

Eunice, Louisiana, 70535, United States

Location

Palatin Clinical Site 186

New Orleans, Louisiana, 70119, United States

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Palatin Clinical Site 183

Bangor, Maine, 04401, United States

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Palatin Clinical Site 159

Annapolis, Maryland, 21401, United States

Location

Palatin Clinical Site 119

Boston, Massachusetts, 02131, United States

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Palatin Clinical Site 126

Watertown, Massachusetts, 02472, United States

Location

Palatin Clinical Site 163

Bingham Farms, Michigan, 48025, United States

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Palatin Clinical Site 181

Rochester, Michigan, 48307, United States

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Palatin Clinical Site 182

Olive Branch, Mississippi, 38654, United States

Location

Palatin Clinical Site 170

St Louis, Missouri, 63141, United States

Location

Palatin Clinical Site 180

Billings, Montana, 59102, United States

Location

Palatin Clinical Site 192

Norfolk, Nebraska, 68701, United States

Location

Palatin Clinical Site 168

Omaha, Nebraska, 68114, United States

Location

Palatin Clinical Site 111

Las Vegas, Nevada, 89106, United States

Location

Palatin Clinical Site 125

Las Vegas, Nevada, 89119, United States

Location

Palatin Clinical Site 109

Las Vegas, Nevada, 89128, United States

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Palatin Clinical Site 195

Las Vegas, Nevada, 89128, United States

Location

Palatin Clinical Site 120

Moorestown, New Jersey, 08057, United States

Location

Palatin Clinical Site 123

Plainsboro, New Jersey, 08536, United States

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Palatin Clinical Site 124

Albuquerque, New Mexico, 87106, United States

Location

Palatin Clinical Site 189

Johnson City, New York, 13790, United States

Location

Palatin Clinical Site 107

New York, New York, 10016, United States

Location

Palatin Clinical Site 158

Port Jefferson, New York, 11777, United States

Location

Palatin Clinical Site 127

Poughkeepsie, New York, 12601, United States

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Palatin Clinical Site 190

Rochester, New York, 14609, United States

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Palatin Clinical Site 137

Charlotte, North Carolina, 28209, United States

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Palatin Clinical Site 135

Winston-Salem, North Carolina, 27103, United States

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Palatin Clinical Site 156

Winston-Salem, North Carolina, 27103, United States

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Palatin Clinical Site 139

Fargo, North Dakota, 58103, United States

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Palatin Clinical Site 140

Akron, Ohio, 44311, United States

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Palatin Clinical Site 122

Beachwood, Ohio, 44122, United States

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Palatin Clinical Site 151

Cincinnati, Ohio, 45227, United States

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Palatin Clinical Site 112

Columbus, Ohio, 43213, United States

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Palatin Clinical Site 115

Englewood, Ohio, 45322, United States

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Palatin Clinical Site 132

Medford, Oregon, 97504, United States

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Palatin Clinical Site 146

Portland, Oregon, 97210, United States

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Palatin Clinical Site 169

Jenkintown, Pennsylvania, 19046, United States

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Palatin Clinical Site 172

Media, Pennsylvania, 19063, United States

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Palatin Clinical Site 117

Warwick, Rhode Island, 02886, United States

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Palatin Clinical Site 162

Anderson, South Carolina, 29621, United States

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Palatin Clinical Site 143

Bluffton, South Carolina, 29910, United States

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Palatin Clinical Site 114

Mt. Pleasant, South Carolina, 29464, United States

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Palatin Clinical Site 145

Mt. Pleasant, South Carolina, 29464, United States

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Palatin Clinical Site 161

Memphis, Tennessee, 38119, United States

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Palatin Clinical Site 129

Nashville, Tennessee, 37203, United States

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Palatin Clinical Site 174

Bryan, Texas, 77802, United States

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Palatin Clinical Site 113

Dallas, Texas, 75231, United States

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Palatin Clinical Site 118

San Antonio, Texas, 78229, United States

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Palatin Clinical Site 176

Sugar Land, Texas, 77479, United States

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Palatin Clinical Site 100

Murray, Utah, 84123, United States

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Palatin Clinical Site 103

Charlottesville, Virginia, 22903, United States

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Palatin Clinical Site 138

Virginia Beach, Virginia, 23456, United States

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Palatin Clinical Site 133

Spokane, Washington, 99207, United States

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Palatin Clinical Site 150

Tacoma, Washington, 98405, United States

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Palatin Clinical Site 193

Middleton, Wisconsin, 53562, United States

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Palatin Clinical Site 304

Halifax, Nova Scotia, B35 1M7, Canada

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Palatin Clinical Site 303

Kentville, Nova Scotia, B4N 4K9, Canada

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Palatin Clinical Site 301

Toronto, Ontario, M9W 4L6, Canada

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Palatin Clinical Site 302

Saint Romuald, Quebec, G6W 5M6, Canada

Location

Related Publications (8)

• 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.

  PMID: 10782451 RESULT

• Spielmans GI, Ellefson EM. Small Effects, Questionable Outcomes: Bremelanotide for Hypoactive Sexual Desire Disorder. J Sex Res. 2024 May;61(4):540-561. doi: 10.1080/00224499.2023.2175192. Epub 2023 Feb 21.

  PMID: 36809187 DERIVED

• 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.

  PMID: 35147466 DERIVED

• 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.

  PMID: 33538638 DERIVED

• 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.

  PMID: 33033885 DERIVED

• 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.

  PMID: 31599847 DERIVED

• 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.

  PMID: 31599840 DERIVED

• 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.

  PMID: 28189361 DERIVED

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Interventions

bremelanotide

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

• Title: Medical Information
• Organization: AMAG Pharmaceuticals

amag@druginfo.com

1-877-411-2510

Study Officials

• Robert Jordan

  Palatin Technologies, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2014
• First Posted: January 7, 2015
• Study Start: December 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: June 30, 2017
• Last Updated: April 9, 2021
• Results First Posted: December 23, 2020

Record last verified: 2020-12

Locations

CA (4); US (87)