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

NCT02338960 | Completed Phase 3 Results DMC

• 2 other identifiers: BMT-302Reconnect Study
• Study Type: interventional
• Target: 714
• 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; decreased desire; female sexual dysfunction

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 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 Outcomes (13)

• 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)

• 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)

• 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)

• 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)

• 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)

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; Drug: 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 DRUG

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
• AMAG Pharmaceuticals, Inc.: collaborator

Study Sites (91)

Palatin Clinical Site 242

Birmingham, Alabama, 35242, United States

Location

Palatin Clinical Site 218

Phoenix, Arizona, 85032, United States

Location

Palatin Clinical Site 254

Tucson, Arizona, 85712, United States

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Palatin Clinical Site 207

Hot Springs, Arkansas, 71901, United States

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Palatin Clinical Site 258

Beverly Hills, California, 90210, United States

Location

Palatin Clinical Site 256

Garden Grove, California, 92845, United States

Location

Palatin Clinical Site 291

Los Angeles, California, 90024, United States

Location

Palatin Clinical Site 270

Oakland, California, 94612, United States

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Palatin Clinical Site 210

San Diego, California, 92120, United States

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Palatin Clinical Site 251

San Diego, California, 92123, United States

Location

Palatin Clinical Site 272

Sherman Oaks, California, 91403, United States

Location

Palatin Clinical Site 253

Tarzana, California, 91356, United States

Location

Palatin Clinical Site 212

Denver, Colorado, 80209, United States

Location

Palatin Clinical Site 219

Denver, Colorado, 80220, United States

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Palatin Clinical Site 243

Lakewood, Colorado, 80228, United States

Location

Palatin Clinical Site 211

New London, Connecticut, 06320, United States

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Palatin Clinical Site 229

Waterbury, Connecticut, 06708, United States

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Palatin Clinical Site 202

Washington D.C., District of Columbia, 20036, United States

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Palatin Clinical Site 204

Aventura, Florida, 33180, United States

Location

Palatin Clinical Site 273

Coral Gables, Florida, 33134, United States

Location

Palatin Clinical Site 203

Fort Myers, Florida, 33912, United States

Location

Palatin Clinical Site 255

Gainesville, Florida, 32607, United States

Location

Palatin Clinical Site 266

Gainesville, Florida, 32607, United States

Location

Palatin Clinical Site 224

Jupiter, Florida, 33458, United States

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Palatin Clinical Site 250

Orlando, Florida, 32806, United States

Location

Palatin Clinical Site 261

Oviedo, Florida, 32765, United States

Location

Palatin Clinical Site 260

Pinellas Park, Florida, 33781, United States

Location

Palatin Clinical Site 236

West Palm Beach, Florida, 33409, United States

Location

Palatin Clinical Site 248

Alpharetta, Georgia, 30005, United States

Location

Palatin Clinical Site 263

Atlanta, Georgia, 30328, United States

Location

Palatin Clinical Site 288

Addison, Illinois, 60101, United States

Location

Palatin Clinical Site 252

Chicago, Illinois, 60640, United States

Location

Palatin Clinical Site 201

Chicago, Illinois, 60654, United States

Location

Palatin Clinical Site 277

Indianapolis, Indiana, 46260, United States

Location

Palatin Clinical Site 247

Prairie Village, Kansas, 66206, United States

Location

Palatin Clinical Site 286

Paducah, Kentucky, 42003, United States

Location

Palatin Clinical Site 279

Lake Charles, Louisiana, 70629, United States

Location

Palatin Clinical Site 281

Metairie, Louisiana, 70002, United States

Location

Palatin Clinical Site 257

Annapolis, Maryland, 21401, United States

Location

Palatin Clinical Site 222

Lutherville, Maryland, 21093, United States

Location

Palatin Clinical Site 283

Rockville, Maryland, 20852, United States

Location

Palatin Clinical Site 265

Boston, Massachusetts, 02131, United States

Location

Palatin Clinical Site 217

New Bedford, Massachusetts, 02740, United States

Location

Palatin Clinical Site 239

Kalamazoo, Michigan, 49009, United States

Location

Palatin Clinical Site 245

Saginaw, Michigan, 48604, United States

Location

Palatin Clinical Site 287

Flowood, Mississippi, 39232, United States

Location

Palatin Clinical Site 244

Kansas City, Missouri, 64114, United States

Location

Palatin Clinical Site 280

St Louis, Missouri, 63043, United States

Location

Palatin Clinical Site 220

Lincoln, Nebraska, 68510, United States

Location

Palatin Clinical Site 290

Berlin, New Jersey, 08009, United States

Location

Palatin Clinical Site 233

Lawrenceville, New Jersey, 08648, United States

Location

Palatin Clinical Site 276

Albuquerque, New Mexico, 87102, United States

Location

Palatin Clinical Site 282

Rochester, New York, 14618, United States

Location

Palatin Clinical Site 264

Cary, North Carolina, 27518, United States

Location

Palatin Clinical Site 206

Raleigh, North Carolina, 27612, United States

Location

Palatin Clinical Site 231

Salisbury, North Carolina, 28144, United States

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Palatin Clinical Site 209

Winston-Salem, North Carolina, 27103, United States

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Palatin Clinical Site 271

Canton, Ohio, 44718, United States

Location

Palatin Clinical Site 215

Cincinnati, Ohio, 45249, United States

Location

Palatin Clinical Site 232

Cleveland, Ohio, 44122, United States

Location

Palatin Clinical Site 246

Columbus, Ohio, 43212, United States

Location

Palatin Clinical Site 221

Mayfield Heights, Ohio, 44124, United States

Location

Palatin Clinical Site 289

Tiffin, Ohio, 44883, United States

Location

Palatin Clinical Site 238

Oklahoma City, Oklahoma, 73103, United States

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Palatin Clinical Site 227

Oklahoma City, Oklahoma, 73112, United States

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Palatin Clinical Site 267

Allentown, Pennsylvania, 18104, United States

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Palatin Clinical Site 234

Philadelphia, Pennsylvania, 19114, United States

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Palatin Clinical Site 240

Pittsburgh, Pennsylvania, 15206, United States

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Palatin Clinical Site 278

Lincoln, Rhode Island, 02865, United States

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Palatin Clinical Site 200

Greer, South Carolina, 29650, United States

Location

Palatin Clinical Site 259

Moncks Corner, South Carolina, 29461, United States

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Palatin Clinical Site 275

Chattanooga, Tennessee, 37403, United States

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Palatin Clinical Site 216

Jackson, Tennessee, 38305, United States

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Palatin Clinical Site 274

Memphis, Tennessee, 38119, United States

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Palatin Clinical Site 292

Nashville, Tennessee, 37201, United States

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Palatin Clinical Site 235

Arlington, Texas, 75230, United States

Location

Palatin Clinical Site 230

Austin, Texas, 78731, United States

Location

Palatin Clinical Site 223

Dallas, Texas, 75234, United States

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Palatin Clinical Site 208

Houston, Texas, 77054, United States

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Palatin Clinical Site 269

Draper, Utah, 84020, United States

Location

Palatin Clinical Site 228

West Jordan, Utah, 84088, United States

Location

Palatin Clinical Site 284

Newport News, Virginia, 23606, United States

Location

Palatin Clinical Site 205

Norfolk, Virginia, 23502, United States

Location

Palatin Clinical Site 213

Richmond, Virginia, 23294, United States

Location

Palatin Clinical Site 268

Richmond, Virginia, 23298, United States

Location

Palatin Clinical Site 214

Seattle, Washington, 98105, United States

Location

Palatin Clinical Site 285

Charleston, West Virginia, 25304, United States

Location

Palatin Clinical Site 400

Vancouver, British Columbia, V6J 1S3, Canada

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Palatin Clinical Site 405

Greater Sudbury, Ontario, P3E 1H5, Canada

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Palatin Clinical Site 401

Pointe-Claire, Quebec, H9R 4S3, Canada

Location

Palatin Clinical Site 404

Sherbrooke, Quebec, J1H 121, 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

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: January 12, 2015
• First Posted: January 15, 2015
• Study Start: January 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: June 29, 2017
• Last Updated: January 28, 2021
• Results First Posted: January 28, 2021

Record last verified: 2020-12

Locations

CA (4); US (87)