1. 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: NCT02333071
• Other study ID #: BMT-301
• Secondary ID: Reconnect Study
• Status: Completed
• Phase: Phase 3
• Start date: December 2014
• Est. completion date: June 30, 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: 723
• Est. completion date: June 30, 2017
• Est. primary completion date: July 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)

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Canada	Palatin Clinical Site 304	Halifax	Nova Scotia
Canada	Palatin Clinical Site 303	Kentville	Nova Scotia
Canada	Palatin Clinical Site 302	Saint Romuald	Quebec
Canada	Palatin Clinical Site 301	Toronto	Ontario
United States	Palatin Clinical Site 140	Akron	Ohio
United States	Palatin Clinical Site 124	Albuquerque	New Mexico
United States	Palatin Clinical Site 162	Anderson	South Carolina
United States	Palatin Clinical Site 159	Annapolis	Maryland
United States	Palatin Clinical Site 183	Bangor	Maine
United States	Palatin Clinical Site 122	Beachwood	Ohio
United States	Palatin Clinical Site 180	Billings	Montana
United States	Palatin Clinical Site 163	Bingham Farms	Michigan
United States	Palatin Clinical Site 121	Birmingham	Alabama
United States	Palatin Clinical Site 143	Bluffton	South Carolina
United States	Palatin Clinical Site 119	Boston	Massachusetts
United States	Palatin Clinical Site 130	Bradenton	Florida
United States	Palatin Clinical Site 174	Bryan	Texas
United States	Palatin Clinical Site 160	Centennial	Colorado
United States	Palatin Clinical Site 137	Charlotte	North Carolina
United States	Palatin Clinical Site 103	Charlottesville	Virginia
United States	Palatin Clinical Site 151	Cincinnati	Ohio
United States	Palatin Clinical Site 185	Colorado Springs	Colorado
United States	Palatin Clinical Site 112	Columbus	Ohio
United States	Palatin Clinical Site 113	Dallas	Texas
United States	Palatin Clinical Site 116	Decatur	Georgia
United States	Palatin Clinical Site 115	Englewood	Ohio
United States	Palatin Clinical Site 194	Eunice	Louisiana
United States	Palatin Clinical Site 179	Evansville	Indiana
United States	Palatin Clinical Site 139	Fargo	North Dakota
United States	Palatin Clinical Site 128	Hollywood	Florida
United States	Palatin Clinical Site 110	Huntsville	Alabama
United States	Palatin Clinical Site 134	Jacksonville	Florida
United States	Palatin Clinical Site 169	Jenkintown	Pennsylvania
United States	Palatin Clinical Site 189	Johnson City	New York
United States	Palatin Clinical Site 165	Lafayette	Indiana
United States	Palatin Clinical Site 109	Las Vegas	Nevada
United States	Palatin Clinical Site 111	Las Vegas	Nevada
United States	Palatin Clinical Site 125	Las Vegas	Nevada
United States	Palatin Clinical Site 195	Las Vegas	Nevada
United States	Palatin Clinical Site 166	Little Rock	Arkansas
United States	Palatin Clinical Site 191	Louisville	Kentucky
United States	Palatin Clinical Site 132	Medford	Oregon
United States	Palatin Clinical Site 172	Media	Pennsylvania
United States	Palatin Clinical Site 108	Melbourne	Florida
United States	Palatin Clinical Site 161	Memphis	Tennessee
United States	Palatin Clinical Site 171	Meridian	Idaho
United States	Palatin Clinical Site 193	Middleton	Wisconsin
United States	Palatin Clinical Site 154	Mishawaka	Indiana
United States	Palatin Clinical Site 106	Mobile	Alabama
United States	Palatin Clinical Site 120	Moorestown	New Jersey
United States	Palatin Clinical Site 114	Mount Pleasant	South Carolina
United States	Palatin Clinical Site 145	Mount Pleasant	South Carolina
United States	Palatin Clinical Site 100	Murray	Utah
United States	Palatin Clinical Site 129	Nashville	Tennessee
United States	Palatin Clinical Site 102	National City	California
United States	Palatin Clinical Site 186	New Orleans	Louisiana
United States	Palatin Clinical Site 107	New York	New York
United States	Palatin Clinical Site 192	Norfolk	Nebraska
United States	Palatin Clinical Site 164	Oceanside	California
United States	Palatin Clinical Site 182	Olive Branch	Mississippi
United States	Palatin Clinical Site 168	Omaha	Nebraska
United States	Palatin Clinical Site 152	Orange	California
United States	Palatin Clinical Site 105	Orlando	Florida
United States	Palatin Clinical Site 155	Overland Park	Kansas
United States	Palatin Clinical Site 123	Plainsboro	New Jersey
United States	Palatin Clinical Site 158	Port Jefferson	New York
United States	Palatin Clinical Site 146	Portland	Oregon
United States	Palatin Clinical Site 127	Poughkeepsie	New York
United States	Palatin Clinical Site 181	Rochester	Michigan
United States	Palatin Clinical Site 190	Rochester	New York
United States	Palatin Clinical Site 188	Sacramento	California
United States	Palatin Clinical Site 170	Saint Louis	Missouri
United States	Palatin Clinical Site 144	Saint Petersburg	Florida
United States	Palatin Clinical Site 118	San Antonio	Texas
United States	Palatin Clinical Site 141	San Diego	California
United States	Palatin Clinical Site 142	Savannah	Georgia
United States	Palatin Clinical Site 149	Scottsdale	Arizona
United States	Palatin Clinical Site 131	South Miami	Florida
United States	Palatin Clinical Site 133	Spokane	Washington
United States	Palatin Clinical Site 176	Sugar Land	Texas
United States	Palatin Clinical Site 150	Tacoma	Washington
United States	Palatin Clinical Site 157	Tucson	Arizona
United States	Palatin Clinical Site 138	Virginia Beach	Virginia
United States	Palatin Clinical Site 187	Walnut Creek	California
United States	Palatin Clinical Site 117	Warwick	Rhode Island
United States	Palatin Clinical Site 126	Watertown	Massachusetts
United States	Palatin Clinical Site 184	West Des Moines	Iowa
United States	Palatin Clinical Site 101	West Palm Beach	Florida
United States	Palatin Clinical Site 104	Wichita	Kansas
United States	Palatin Clinical Site 135	Winston-Salem	North Carolina
United States	Palatin Clinical Site 156	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Palatin Technologies

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.; 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)
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 (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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)