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

Primary Purpose

Hypoactive Sexual Desire Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bremelanotide
Placebo
Sponsored by
Palatin Technologies, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoactive Sexual Desire Disorder focused on measuring HSDD, Female Sexual Desire Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Palatin Clinical Site 121
  • Palatin Clinical Site 110
  • Palatin Clinical Site 106
  • Palatin Clinical Site 149
  • Palatin Clinical Site 157
  • Palatin Clinical Site 166
  • Palatin Clinical Site 102
  • Palatin Clinical Site 164
  • Palatin Clinical Site 152
  • Palatin Clinical Site 188
  • Palatin Clinical Site 141
  • Palatin Clinical Site 187
  • Palatin Clinical Site 160
  • Palatin Clinical Site 185
  • Palatin Clinical Site 130
  • Palatin Clinical Site 128
  • Palatin Clinical Site 134
  • Palatin Clinical Site 108
  • Palatin Clinical Site 105
  • Palatin Clinical Site 144
  • Palatin Clinical Site 131
  • Palatin Clinical Site 101
  • Palatin Clinical Site 116
  • Palatin Clinical Site 142
  • Palatin Clinical Site 171
  • Palatin Clinical Site 179
  • Palatin Clinical Site 165
  • Palatin Clinical Site 154
  • Palatin Clinical Site 184
  • Palatin Clinical Site 155
  • Palatin Clinical Site 104
  • Palatin Clinical Site 191
  • Palatin Clinical Site 194
  • Palatin Clinical Site 186
  • Palatin Clinical Site 183
  • Palatin Clinical Site 159
  • Palatin Clinical Site 119
  • Palatin Clinical Site 126
  • Palatin Clinical Site 163
  • Palatin Clinical Site 181
  • Palatin Clinical Site 182
  • Palatin Clinical Site 170
  • Palatin Clinical Site 180
  • Palatin Clinical Site 192
  • Palatin Clinical Site 168
  • Palatin Clinical Site 111
  • Palatin Clinical Site 125
  • Palatin Clinical Site 109
  • Palatin Clinical Site 195
  • Palatin Clinical Site 120
  • Palatin Clinical Site 123
  • Palatin Clinical Site 124
  • Palatin Clinical Site 189
  • Palatin Clinical Site 107
  • Palatin Clinical Site 158
  • Palatin Clinical Site 127
  • Palatin Clinical Site 190
  • Palatin Clinical Site 137
  • Palatin Clinical Site 135
  • Palatin Clinical Site 156
  • Palatin Clinical Site 139
  • Palatin Clinical Site 140
  • Palatin Clinical Site 122
  • Palatin Clinical Site 151
  • Palatin Clinical Site 112
  • Palatin Clinical Site 115
  • Palatin Clinical Site 132
  • Palatin Clinical Site 146
  • Palatin Clinical Site 169
  • Palatin Clinical Site 172
  • Palatin Clinical Site 117
  • Palatin Clinical Site 162
  • Palatin Clinical Site 143
  • Palatin Clinical Site 114
  • Palatin Clinical Site 145
  • Palatin Clinical Site 161
  • Palatin Clinical Site 129
  • Palatin Clinical Site 174
  • Palatin Clinical Site 113
  • Palatin Clinical Site 118
  • Palatin Clinical Site 176
  • Palatin Clinical Site 100
  • Palatin Clinical Site 103
  • Palatin Clinical Site 138
  • Palatin Clinical Site 133
  • Palatin Clinical Site 150
  • Palatin Clinical Site 193
  • Palatin Clinical Site 304
  • Palatin Clinical Site 303
  • Palatin Clinical Site 301
  • Palatin Clinical Site 302

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bremelanotide (BMT/BMT)

Placebo (PBO/BMT)

Arm Description

(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

(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

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

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.
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.
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).
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).
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.
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.
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.
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.
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.
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.
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.
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).
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.

Full Information

First Posted
December 28, 2014
Last Updated
March 16, 2021
Sponsor
Palatin Technologies, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02333071
Brief Title
1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Palatin Technologies, Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoactive Sexual Desire Disorder
Keywords
HSDD, Female Sexual Desire Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
723 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bremelanotide (BMT/BMT)
Arm Type
Experimental
Arm Description
(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
Arm Title
Placebo (PBO/BMT)
Arm Type
Placebo Comparator
Arm Description
(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
Intervention Type
Drug
Intervention Name(s)
Bremelanotide
Other Intervention Name(s)
BMT, PT-141
Intervention Description
A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
PBO
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Efficacy of a Fixed Dose of Bremelanotide as Measured by FSFI (Question Q1 and Q2), 28-day Recall.
Description
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.
Time Frame
8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Title
Efficacy of a Fixed Dose of Bremelanotide as Measured by FSDS-DAO (Item 13)
Description
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).
Time Frame
8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Title
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
Description
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.
Time Frame
8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Title
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
Description
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).
Time Frame
8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Title
Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the FSDS-DAO Total Score
Description
FSDS-DAO = Female Sexual Distress Scale - Desire/Arousal/Orgasm Scores range from 0 (never feel bothered) to 60 (always feel bothered).
Time Frame
8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Title
Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Total FSFI Total Score
Description
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.
Time Frame
8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Title
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
Description
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.
Time Frame
8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Title
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
Description
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.
Time Frame
8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Title
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
Description
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.
Time Frame
8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Title
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)
Description
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.
Time Frame
8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Title
Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Total Number of SSEs
Description
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.
Time Frame
8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Title
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
Description
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.
Time Frame
24 weeks (Main Study)
Title
Change From Baseline to End of Study in the Total Score for FSDS-DAO (Item 13) Throughout the Entirety of the Double-blind Phase
Description
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).
Time Frame
24 weeks (Main Study)
Title
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
Description
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.
Time Frame
24 weeks (Main Study)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Jordan
Organizational Affiliation
Palatin Technologies, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Palatin Clinical Site 121
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
Palatin Clinical Site 110
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Palatin Clinical Site 106
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Palatin Clinical Site 149
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Palatin Clinical Site 157
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Palatin Clinical Site 166
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Palatin Clinical Site 102
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Palatin Clinical Site 164
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Palatin Clinical Site 152
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Palatin Clinical Site 188
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Palatin Clinical Site 141
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Palatin Clinical Site 187
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Palatin Clinical Site 160
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80239
Country
United States
Facility Name
Palatin Clinical Site 185
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Palatin Clinical Site 130
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Palatin Clinical Site 128
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Palatin Clinical Site 134
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Palatin Clinical Site 108
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32934
Country
United States
Facility Name
Palatin Clinical Site 105
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Palatin Clinical Site 144
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Palatin Clinical Site 131
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Palatin Clinical Site 101
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Palatin Clinical Site 116
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Palatin Clinical Site 142
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Palatin Clinical Site 171
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Palatin Clinical Site 179
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47710
Country
United States
Facility Name
Palatin Clinical Site 165
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47905
Country
United States
Facility Name
Palatin Clinical Site 154
City
Mishawaka
State/Province
Indiana
ZIP/Postal Code
46545
Country
United States
Facility Name
Palatin Clinical Site 184
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Palatin Clinical Site 155
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66202
Country
United States
Facility Name
Palatin Clinical Site 104
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67211
Country
United States
Facility Name
Palatin Clinical Site 191
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40291
Country
United States
Facility Name
Palatin Clinical Site 194
City
Eunice
State/Province
Louisiana
ZIP/Postal Code
70535
Country
United States
Facility Name
Palatin Clinical Site 186
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
Facility Name
Palatin Clinical Site 183
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Palatin Clinical Site 159
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Palatin Clinical Site 119
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Palatin Clinical Site 126
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Palatin Clinical Site 163
City
Bingham Farms
State/Province
Michigan
ZIP/Postal Code
48025
Country
United States
Facility Name
Palatin Clinical Site 181
City
Rochester
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States
Facility Name
Palatin Clinical Site 182
City
Olive Branch
State/Province
Mississippi
ZIP/Postal Code
38654
Country
United States
Facility Name
Palatin Clinical Site 170
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Palatin Clinical Site 180
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Palatin Clinical Site 192
City
Norfolk
State/Province
Nebraska
ZIP/Postal Code
68701
Country
United States
Facility Name
Palatin Clinical Site 168
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Palatin Clinical Site 111
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Palatin Clinical Site 125
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Palatin Clinical Site 109
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Palatin Clinical Site 195
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Palatin Clinical Site 120
City
Moorestown
State/Province
New Jersey
ZIP/Postal Code
08057
Country
United States
Facility Name
Palatin Clinical Site 123
City
Plainsboro
State/Province
New Jersey
ZIP/Postal Code
08536
Country
United States
Facility Name
Palatin Clinical Site 124
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Palatin Clinical Site 189
City
Johnson City
State/Province
New York
ZIP/Postal Code
13790
Country
United States
Facility Name
Palatin Clinical Site 107
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Palatin Clinical Site 158
City
Port Jefferson
State/Province
New York
ZIP/Postal Code
11777
Country
United States
Facility Name
Palatin Clinical Site 127
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Palatin Clinical Site 190
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Palatin Clinical Site 137
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Palatin Clinical Site 135
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Palatin Clinical Site 156
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Palatin Clinical Site 139
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Palatin Clinical Site 140
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
Facility Name
Palatin Clinical Site 122
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Palatin Clinical Site 151
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Palatin Clinical Site 112
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Palatin Clinical Site 115
City
Englewood
State/Province
Ohio
ZIP/Postal Code
45322
Country
United States
Facility Name
Palatin Clinical Site 132
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Palatin Clinical Site 146
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Palatin Clinical Site 169
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Palatin Clinical Site 172
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Palatin Clinical Site 117
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Palatin Clinical Site 162
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Palatin Clinical Site 143
City
Bluffton
State/Province
South Carolina
ZIP/Postal Code
29910
Country
United States
Facility Name
Palatin Clinical Site 114
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Palatin Clinical Site 145
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Palatin Clinical Site 161
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Palatin Clinical Site 129
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Palatin Clinical Site 174
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
Palatin Clinical Site 113
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Palatin Clinical Site 118
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Palatin Clinical Site 176
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Palatin Clinical Site 100
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Facility Name
Palatin Clinical Site 103
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Palatin Clinical Site 138
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456
Country
United States
Facility Name
Palatin Clinical Site 133
City
Spokane
State/Province
Washington
ZIP/Postal Code
99207
Country
United States
Facility Name
Palatin Clinical Site 150
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Palatin Clinical Site 193
City
Middleton
State/Province
Wisconsin
ZIP/Postal Code
53562
Country
United States
Facility Name
Palatin Clinical Site 304
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B35 1M7
Country
Canada
Facility Name
Palatin Clinical Site 303
City
Kentville
State/Province
Nova Scotia
ZIP/Postal Code
B4N 4K9
Country
Canada
Facility Name
Palatin Clinical Site 301
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W 4L6
Country
Canada
Facility Name
Palatin Clinical Site 302
City
Saint Romuald
State/Province
Quebec
ZIP/Postal Code
G6W 5M6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
10782451
Citation
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.
Results Reference
result
PubMed Identifier
35147466
Citation
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.
Results Reference
derived
PubMed Identifier
33538638
Citation
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.
Results Reference
derived
PubMed Identifier
33033885
Citation
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.
Results Reference
derived
PubMed Identifier
31599847
Citation
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.
Results Reference
derived
PubMed Identifier
31599840
Citation
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.
Results Reference
derived
PubMed Identifier
28189361
Citation
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.
Results Reference
derived

Learn more about this trial

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

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