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A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial With an Open-label Extension

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ClinicalTrials.gov Identifier: NCT02333071
Recruitment Status : Completed
First Posted : January 7, 2015
Last Update Posted : July 6, 2017
Sponsor:
Collaborator:
PRA Health Sciences
Information provided by (Responsible Party):
Palatin Technologies

Brief Summary:
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an 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.

Condition or disease Intervention/treatment Phase
Hypoactive Sexual Desire Disorder Drug: bremelanotide Other: Placebo Phase 3

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) a 32-week phase including a randomized, double-blind treatment period preceded by a screening/baseline period (Core Study) and (2) a 52 week open-label treatment phase (Extension Phase).

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  (Clinical Trial)
Actual Enrollment : 723 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Study Start Date : December 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : June 30, 2017

Arm Intervention/treatment
Experimental: Bremelanotide
Subjects will self-administer a fixed dose of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours.
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
Subjects will self-administer a fixed dose of placebo subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours.
Other: Placebo
Placebo




Primary Outcome Measures :
  1. Efficacy of a fixed dose of bremelanotide as measured by FSFI (Question Q1 and Q2), 28-day recall. [ Time Frame: 32 weeks ]
    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

  2. Efficacy of a fixed dose of bremelanotide as measured by FSDS-DAO (item 13) [ Time Frame: 32 weeks ]
    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).: co-primary endpoint - FSDS-DAO bothered by low desire item 13


Secondary Outcome Measures :
  1. 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 [ Time Frame: 32 weeks ]
  2. 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 [ Time Frame: 32 weeks ]
  3. 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 [ Time Frame: 32 weeks ]
  4. Efficacy of a fixed dose of bremelanotide, as measured by a change from baseline to End of Study in the FSDS-DAO total score [ Time Frame: 32 weeks ]
  5. Efficacy of a fixed dose of bremelanotide, as measured by a change from baseline to End of Study in the FSFI total score [ Time Frame: 32 weeks ]
  6. 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 [ Time Frame: 32 weeks ]
  7. 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 [ Time Frame: 32 weeks ]
  8. 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 [ Time Frame: 32 weeks ]
  9. 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) [ Time Frame: 32 weeks ]
  10. Efficacy of a fixed dose of bremelanotide, as measured by a change from baseline to End of Study in the total number of SSEs [ Time Frame: 32 weeks ]
  11. 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 [ Time Frame: 32 weeks ]
  12. Efficacy of a fixed dose of bremelanotide, as measured by a change from 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 [ Time Frame: 32 weeks ]
  13. 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 [ Time Frame: 32 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02333071


  Show 91 Study Locations
Sponsors and Collaborators
Palatin Technologies
PRA Health Sciences
Investigators
Study Director: Robert Jordan Palatin Technologies, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Palatin Technologies
ClinicalTrials.gov Identifier: NCT02333071     History of Changes
Other Study ID Numbers: BMT-301
Reconnect Study ( Other Identifier: Palatin Technologies, Inc. )
First Posted: January 7, 2015    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017

Keywords provided by Palatin Technologies:
HSDD
Female Sexual Desire Disorder

Additional relevant MeSH terms:
Hypokinesia
Sexual Dysfunctions, Psychological
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mental Disorders
alpha-MSH
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs