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

Hypoactive Sexual Desire Disorder Clinical Trial

— HSDD  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02338960
• Other study ID #: BMT-302
• Secondary ID: Reconnect Study
• Status: Completed
• Phase: Phase 3
• Start date: January 2015
• Est. completion date: June 29, 2017

Study information

• Verified date: December 2020
• Source: Palatin Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 714
• Est. completion date: June 29, 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Hypoactive Sexual Desire Disorder
• Hypokinesia
• Sexual Dysfunctions, Psychological

Intervention

Drug:
• Bremelanotide
A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)
• Placebo
Placebo

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Palatin Technologies	AMAG Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)