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

• Sponsor: Palatin Technologies, Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02333071
• Collaborator: (none)
• Enrollment: 723
• Locations: 91
• Arms: 2
• Duration (Months): 30.9
• Patients Per Site: 7.9
• Patients Per Site Per Month: 0.3

Study Details

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.

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) 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.

Study Design

• Study Type: Interventional
• 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: Dec 1, 2014
• Actual Primary Completion Date: Jul 1, 2016
• Actual Study Completion Date: Jun 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bremelanotide (BMT/BMT) (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; 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 (PBO/BMT) (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; A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone); Other Names: BMT PT-141 ; Other: Placebo; Placebo; Other Names: PBO

Outcome Measures

Primary Outcome Measures

1. Efficacy of a Fixed Dose of Bremelanotide as Measured by FSFI (Question Q1 and Q2), 28-day Recall. [8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)]

   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.

2. Efficacy of a Fixed Dose of Bremelanotide as Measured by FSDS-DAO (Item 13) [8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)]

   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

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 [8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)]

   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.

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 [8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)]

   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.

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 [8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)]

   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).

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 [8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)]

   FSDS-DAO = Female Sexual Distress Scale - Desire/Arousal/Orgasm Scores range from 0 (never feel bothered) to 60 (always feel bothered).

5. Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Total FSFI Total Score [8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)]

   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.

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 [8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)]

   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.

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 [8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)]

   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. 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 [8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)]

   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.

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) [8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)]

   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.

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 [8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)]

    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.

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 [24 weeks (Main Study)]

    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.

12. Change From Baseline to End of Study in the Total Score for FSDS-DAO (Item 13) Throughout the Entirety of the Double-blind Phase [24 weeks (Main Study)]

    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).

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 [24 weeks (Main Study)]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Palatin Clinical Site 121	Birmingham	Alabama	United States	35211
2	Palatin Clinical Site 110	Huntsville	Alabama	United States	35801
3	Palatin Clinical Site 106	Mobile	Alabama	United States	36608
4	Palatin Clinical Site 149	Scottsdale	Arizona	United States	85251
5	Palatin Clinical Site 157	Tucson	Arizona	United States	85712
6	Palatin Clinical Site 166	Little Rock	Arkansas	United States	72205
7	Palatin Clinical Site 102	National City	California	United States	91950
8	Palatin Clinical Site 164	Oceanside	California	United States	92056
9	Palatin Clinical Site 152	Orange	California	United States	92868
10	Palatin Clinical Site 188	Sacramento	California	United States	95821
11	Palatin Clinical Site 141	San Diego	California	United States	92103
12	Palatin Clinical Site 187	Walnut Creek	California	United States	94598
13	Palatin Clinical Site 160	Centennial	Colorado	United States	80239
14	Palatin Clinical Site 185	Colorado Springs	Colorado	United States	80907
15	Palatin Clinical Site 130	Bradenton	Florida	United States	34208
16	Palatin Clinical Site 128	Hollywood	Florida	United States	33024
17	Palatin Clinical Site 134	Jacksonville	Florida	United States	32256
18	Palatin Clinical Site 108	Melbourne	Florida	United States	32934
19	Palatin Clinical Site 105	Orlando	Florida	United States	32801
20	Palatin Clinical Site 144	Saint Petersburg	Florida	United States	33709
21	Palatin Clinical Site 131	South Miami	Florida	United States	33143
22	Palatin Clinical Site 101	West Palm Beach	Florida	United States	33401
23	Palatin Clinical Site 116	Decatur	Georgia	United States	30030
24	Palatin Clinical Site 142	Savannah	Georgia	United States	31406
25	Palatin Clinical Site 171	Meridian	Idaho	United States	83642
26	Palatin Clinical Site 179	Evansville	Indiana	United States	47710
27	Palatin Clinical Site 165	Lafayette	Indiana	United States	47905
28	Palatin Clinical Site 154	Mishawaka	Indiana	United States	46545
29	Palatin Clinical Site 184	West Des Moines	Iowa	United States	50266
30	Palatin Clinical Site 155	Overland Park	Kansas	United States	66202
31	Palatin Clinical Site 104	Wichita	Kansas	United States	67211
32	Palatin Clinical Site 191	Louisville	Kentucky	United States	40291
33	Palatin Clinical Site 194	Eunice	Louisiana	United States	70535
34	Palatin Clinical Site 186	New Orleans	Louisiana	United States	70119
35	Palatin Clinical Site 183	Bangor	Maine	United States	04401
36	Palatin Clinical Site 159	Annapolis	Maryland	United States	21401
37	Palatin Clinical Site 119	Boston	Massachusetts	United States	02131
38	Palatin Clinical Site 126	Watertown	Massachusetts	United States	02472
39	Palatin Clinical Site 163	Bingham Farms	Michigan	United States	48025
40	Palatin Clinical Site 181	Rochester	Michigan	United States	48307
41	Palatin Clinical Site 182	Olive Branch	Mississippi	United States	38654
42	Palatin Clinical Site 170	Saint Louis	Missouri	United States	63141
43	Palatin Clinical Site 180	Billings	Montana	United States	59102
44	Palatin Clinical Site 192	Norfolk	Nebraska	United States	68701
45	Palatin Clinical Site 168	Omaha	Nebraska	United States	68114
46	Palatin Clinical Site 111	Las Vegas	Nevada	United States	89106
47	Palatin Clinical Site 125	Las Vegas	Nevada	United States	89119
48	Palatin Clinical Site 109	Las Vegas	Nevada	United States	89128
49	Palatin Clinical Site 195	Las Vegas	Nevada	United States	89128
50	Palatin Clinical Site 120	Moorestown	New Jersey	United States	08057
51	Palatin Clinical Site 123	Plainsboro	New Jersey	United States	08536
52	Palatin Clinical Site 124	Albuquerque	New Mexico	United States	87106
53	Palatin Clinical Site 189	Johnson City	New York	United States	13790
54	Palatin Clinical Site 107	New York	New York	United States	10016
55	Palatin Clinical Site 158	Port Jefferson	New York	United States	11777
56	Palatin Clinical Site 127	Poughkeepsie	New York	United States	12601
57	Palatin Clinical Site 190	Rochester	New York	United States	14609
58	Palatin Clinical Site 137	Charlotte	North Carolina	United States	28209
59	Palatin Clinical Site 135	Winston-Salem	North Carolina	United States	27103
60	Palatin Clinical Site 156	Winston-Salem	North Carolina	United States	27103
61	Palatin Clinical Site 139	Fargo	North Dakota	United States	58103
62	Palatin Clinical Site 140	Akron	Ohio	United States	44311
63	Palatin Clinical Site 122	Beachwood	Ohio	United States	44122
64	Palatin Clinical Site 151	Cincinnati	Ohio	United States	45227
65	Palatin Clinical Site 112	Columbus	Ohio	United States	43213
66	Palatin Clinical Site 115	Englewood	Ohio	United States	45322
67	Palatin Clinical Site 132	Medford	Oregon	United States	97504
68	Palatin Clinical Site 146	Portland	Oregon	United States	97210
69	Palatin Clinical Site 169	Jenkintown	Pennsylvania	United States	19046
70	Palatin Clinical Site 172	Media	Pennsylvania	United States	19063
71	Palatin Clinical Site 117	Warwick	Rhode Island	United States	02886
72	Palatin Clinical Site 162	Anderson	South Carolina	United States	29621
73	Palatin Clinical Site 143	Bluffton	South Carolina	United States	29910
74	Palatin Clinical Site 114	Mount Pleasant	South Carolina	United States	29464
75	Palatin Clinical Site 145	Mount Pleasant	South Carolina	United States	29464
76	Palatin Clinical Site 161	Memphis	Tennessee	United States	38119
77	Palatin Clinical Site 129	Nashville	Tennessee	United States	37203
78	Palatin Clinical Site 174	Bryan	Texas	United States	77802
79	Palatin Clinical Site 113	Dallas	Texas	United States	75231
80	Palatin Clinical Site 118	San Antonio	Texas	United States	78229
81	Palatin Clinical Site 176	Sugar Land	Texas	United States	77479
82	Palatin Clinical Site 100	Murray	Utah	United States	84123
83	Palatin Clinical Site 103	Charlottesville	Virginia	United States	22903
84	Palatin Clinical Site 138	Virginia Beach	Virginia	United States	23456
85	Palatin Clinical Site 133	Spokane	Washington	United States	99207
86	Palatin Clinical Site 150	Tacoma	Washington	United States	98405
87	Palatin Clinical Site 193	Middleton	Wisconsin	United States	53562
88	Palatin Clinical Site 304	Halifax	Nova Scotia	Canada	B35 1M7
89	Palatin Clinical Site 303	Kentville	Nova Scotia	Canada	B4N 4K9
90	Palatin Clinical Site 301	Toronto	Ontario	Canada	M9W 4L6
91	Palatin Clinical Site 302	Saint Romuald	Quebec	Canada	G6W 5M6

Sponsors and Collaborators

• Palatin Technologies, Inc

Investigators

• Study Director: Robert Jordan, Palatin Technologies, Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Palatin Technologies, Inc
• ClinicalTrials.gov Identifier: NCT02333071
• Other Study ID Numbers: BMT-301; Reconnect Study
• First Posted: Jan 7, 2015
• Last Update Posted: Apr 9, 2021
• Last Verified: Dec 1, 2020

• Keywords provided by Palatin Technologies, Inc: HSDD; Female Sexual Desire Disorder
• Additional relevant MeSH terms: Hypokinesia; Disease; Sexual Dysfunctions, Psychological

Study Results

Participant Flow

Recruitment Details	Core ("Main") Study consisted of a 4-week no drug Screening period, followed by a 4-week single blind PBO period, first dose administered in-clinic. Following the end of single-blind period, which served as Baseline, eligible subjects were then randomized to a 24-week double-blind outpatient treatment period, first dose administered in-clinic.
Pre-assignment Detail	Core Study: 723 participants enrolled, 70 run-in failures 653 participants were randomized. OLE Study (optional): Of the 464 completers of the Core study, 363 participants enrolled in optional OLE study. The OLE study was not reported and has no NCT number.

Arm/Group Title	Placebo PBO/BMT	Bremelanotide BMT/BMT
Arm/Group Description	Core Study: 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 for 24 weeks. Placebo OLE Study: 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 for 52 weeks. bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)	Core and OLE Study: 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 for 24 weeks. bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)
Period Title: Core Study
STARTED	326	327
Received Intervention	319	324
COMPLETED	274	190
NOT COMPLETED	52	137
Period Title: Core Study
STARTED	239	124
COMPLETED	95	49
NOT COMPLETED	144	75

Baseline Characteristics

Arm/Group Title	Bremelanotide (BMT/BMT)	Placebo (PBO/BMT)	Total
Arm/Group Description	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 (Main) followed by a 52-week open label extension study (OLE) BMT/BMT bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)	Subjects will self-administer a fixed dose of placebo (PBO) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours (Main) followed by a 52-week open label extension study (OLE) where participants receive only BMT, no placebo PBO/BMT Placebo: Placebo bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)	Total of all reporting groups
Overall Participants	324	319	643
Age (Years) [Mean (Standard Deviation) ]
Main	38.4 (6.95)	38.5 (7.22)	38.5 (7.08)
OLE	38.5 (6.72)	38.8 (6.93)	38.7 (6.85)
Sex: Female, Male (Count of Participants)
Female	324 100%	319 100%	643 100%
Male	0 0%	0 0%	0 0%
Female	124 38.3%	239 74.9%	363 56.5%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	33 10.2%	31 9.7%	64 10%
Not Hispanic or Latino	291 89.8%	288 90.3%	579 90%
Unknown or Not Reported	0 0%	0 0%	0 0%
Hispanic or Latino	13 4%	20 6.3%	33 5.1%
Not Hispanic or Latino	111 34.3%	219 68.7%	330 51.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	3 0.9%	1 0.3%	4 0.6%
Asian	2 0.6%	3 0.9%	5 0.8%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	44 13.6%	42 13.2%	86 13.4%
White	273 84.3%	269 84.3%	542 84.3%
More than one race	1 0.3%	3 0.9%	4 0.6%
Unknown or Not Reported	1 0.3%	1 0.3%	2 0.3%
American Indian or Alaska Native	2 0.6%	0 0%	2 0.3%
Asian	2 0.6%	2 0.6%	4 0.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	17 5.2%	29 9.1%	46 7.2%
White	101 31.2%	204 63.9%	305 47.4%
More than one race	1 0.3%	3 0.9%	4 0.6%
Unknown or Not Reported	1 0.3%	1 0.3%	2 0.3%

Outcome Measures

1. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

A total of 363 of the 464 subjects who completed the Core Study Phase continued into the optional OLE Study Phase, including 124 in the BMT/BMT group and 239 in the PBO/BMT group.

Arm/Group Title	Bremelanotide BMT/BMT	Placebo PBO/BMT
Arm/Group 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 bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)	(Main Study) PBO administered SC on an as-desired basis for 24 weeks Placebo: Placebo (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 Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)
Measure Participants	313	315
Main study	0.54 (1.106)	0.24 (0.994)
Open label extension	1.30 (1.105)	0.77 (1.138)

2. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

A total of 363 of the 464 (78.2%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase.

Arm/Group Title	Bremelanotide BMT/BMT	Placebo PBO/BMT
Arm/Group 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 bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)	(Main Study) PBO administered SC on an as-desired basis for 24 weeks Placebo: Placebo (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 Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)
Measure Participants	313	314
Main study	-0.73 (1.203)	-0.36 (1.082)
Open label extension	-1.7 (1.21)	-0.9 (1.10)

3. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

A total of 363 of the 464 (78.2%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 146 participants in the OLE study completed the 52 weeks.

Arm/Group Title	Bremelanotide BMT/BMT	Placebo PBO/BMT
Arm/Group 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 bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)	(Main Study) PBO administered SC on an as-desired basis for 24 weeks Placebo: Placebo (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 Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)
Measure Participants	314	316
Main study	0.0 (1.44)	-0.1 (1.35)
Open label extension	0.28 (1.457)	0.10 (1.189)

4. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

A total of 363 of the 464 (78.2%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 146 participants in the OLE study completed the 52 weeks.

Arm/Group Title	Bremelanotide BMT/BMT	Placebo PBO/BMT
Arm/Group 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 bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)	(Main Study) PBO administered SC on an as-desired basis for 24 weeks Placebo: Placebo (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 Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)
Measure Participants	314	316
Main study	0.0 (1.09)	0.1 (0.92)
Open label extension	0.66 (0.975)	0.38 (1.107)

5. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

A total of 363 of the 464 (78.2%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 146 participants in the OLE study completed the 52 weeks.

Arm/Group Title	Bremelanotide BMT/BMT	Placebo PBO/BMT
Arm/Group 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 bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)	(Main Study) PBO administered SC on an as-desired basis for 24 weeks Placebo: Placebo (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 Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)
Measure Participants	314	316
Main study	0.2 (1.15)	0.0 (0.96)
Open label extension	0.93 (1.141)	0.59 (1.054)

6. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

A total of 363 of the 464 (78.2%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 146 participants in the OLE study completed the 52 weeks.

Arm/Group Title	Bremelanotide BMT/BMT	Placebo PBO/BMT
Arm/Group 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 bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)	(Main Study) PBO administered SC on an as-desired basis for 24 weeks Placebo: Placebo (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 Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)
Measure Participants	313	314
Main study	-9.2 (13.86)	-5.5 (12.27)
Open label extension	-21.4 (13.96)	-12.0 (13.66)

7. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

A total of 363 of the 464 (78.2%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 146 participants in the OLE study completed the 52 weeks.

Arm/Group Title	Bremelanotide BMT/BMT	Placebo PBO/BMT
Arm/Group 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 bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)	(Main Study) PBO administered SC on an as-desired basis for 24 weeks Placebo: Placebo (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 Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)
Measure Participants	313	315
Main study	2.69 (7.317)	0.95 (5.963)
Open label extension	7.71 (8.076)	3.95 (6.740)

8. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

A total of 363 of the 464 (78.2%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 146 participants in the OLE study completed the 52 weeks.

Arm/Group Title	Bremelanotide BMT/BMT	Placebo PBO/BMT
Arm/Group 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 bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)	(Main Study) PBO administered SC on an as-desired basis for 24 weeks Placebo: Placebo (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 Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)
Measure Participants	314	316
Main study	0.1 (1.11)	-0.1 (0.93)
Open label extension	0.65 (1.035)	0.43 (1.029)

9. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

A total of 363 of the 464 (78.2%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 146 participants in the OLE study completed the 52 weeks.

Arm/Group Title	Bremelanotide BMT/BMT	Placebo PBO/BMT
Arm/Group 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 bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)	(Main Study) PBO administered SC on an as-desired basis for 24 weeks Placebo: Placebo (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 Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)
Measure Participants	314	316
Main study	0.2 (1.20)	-0.1 (1.02)
Open label extension	0.99 (1.170)	0.60 (1.116)

10. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

A total of 363 of the 464 (78.2%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 146 participants in the OLE study completed the 52 weeks.

Arm/Group Title	Bremelanotide BMT/BMT	Placebo PBO/BMT
Arm/Group 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 bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)	(Main Study) PBO administered SC on an as-desired basis for 24 weeks Placebo: Placebo (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 Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)
Measure Participants	313	314
Main study	-0.6 (1.24)	-0.4 (1.07)
Open label extension	-1.5 (1.23)	-1.0 (1.12)

11. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

A total of 363 of the 464 (78.2%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 146 participants in the OLE study completed the 52 weeks.

Arm/Group Title	Bremelanotide BMT/BMT	Placebo PBO/BMT
Arm/Group 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 bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)	(Main Study) PBO administered SC on an as-desired basis for 24 weeks Placebo: Placebo (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 Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)
Measure Participants	313	315
Main study	0.66 (1.596)	0.16 (1.240)
Open label extension	1.46 (1.724)	1.08 (1.581)

12. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

A total of 363 of the 464 (78.2%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 146 participants in the OLE study completed the 52 weeks.

Arm/Group Title	Bremelanotide BMT/BMT	Placebo PBO/BMT
Arm/Group 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 bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)	(Main Study) PBO administered SC on an as-desired basis for 24 weeks Placebo: Placebo (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 Bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)
Measure Participants	314	316
Main study	-0.1 (1.76)	-0.2 (1.79)
Open label extension	0.65 (1.676)	0.05 (1.553)

13. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

Number of participants in just the double-blind study. The OLE study was not a double-blind study.

Arm/Group Title	Bremelanotide BMT	Placebo PBO
Arm/Group 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 bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)	(Main Study) PBO administered SC on an as-desired basis for 24 weeks Placebo: Placebo
Measure Participants	192	272
Mean (Standard Deviation) [score on a scale]	0.69 (1.114)	0.23 (0.933)

14. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

Number of participants in just the double-blind study. The OLE study was not a double-blind study.

Arm/Group Title	Bremelanotide BMT	Placebo PBO
Arm/Group 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 bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)	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. Placebo: Placebo
Measure Participants	192	271
Mean (Standard Deviation) [score on a scale]	-0.9 (1.23)	-0.3 (1.05)

15. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

Number of participants in just the double-blind study. The OLE study was not a double-blind study.

Arm/Group Title	Bremelanotide BMT	Placebo PBO
Arm/Group 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 bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)	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. Placebo: Placebo
Measure Participants	193	276
Mean (Standard Deviation) [events]	0.1 (1.66)	-0.1 (1.37)

Adverse Events

Time Frame	6 months (Main study), 12 months (Open Label study)
Adverse Event Reporting Description	Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
Arm/Group Title	Bremelanotide (Main Study)		Placebo (Main Study)		Bremelanotide (OLE)		Placebo (OLE)
Arm/Group Description	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. bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)		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. Placebo: Placebo		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 bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)		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 f or 52 weeks. bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)
All Cause Mortality
	Bremelanotide (Main Study)		Placebo (Main Study)		Bremelanotide (OLE)		Placebo (OLE)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/324 (0%)		0/319 (0%)		0/124 (0%)		0/239 (0%)
Serious Adverse Events
	Bremelanotide (Main Study)		Placebo (Main Study)		Bremelanotide (OLE)		Placebo (OLE)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/324 (1.2%)		1/319 (0.3%)		0/124 (0%)		2/239 (0.8%)
Cardiac disorders
Cerebrovascular accident	0/324 (0%)	0	0/319 (0%)	0	0/124 (0%)	0	1/239 (0.4%)	1
Gastrointestinal disorders
Abdominal hernia obstructive	1/324 (0.3%)	1	0/319 (0%)	0	0/124 (0%)	0	0/239 (0%)	0
Colitis	0/324 (0%)	0	1/319 (0.3%)	1	0/124 (0%)	0	0/239 (0%)	0
Peritoneal hemorrhage	1/324 (0.3%)	1	0/319 (0%)	0	0/124 (0%)	0	0/239 (0%)	0
Vomiting	1/324 (0.3%)	1	0/319 (0%)	0	0/124 (0%)	0	0/239 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma	1/324 (0.3%)	1	0/319 (0%)	0	0/124 (0%)	0	0/239 (0%)	0
Nervous system disorders
Headache	1/324 (0.3%)	1	0/319 (0%)	0	0/124 (0%)	0	0/239 (0%)	0
Pregnancy, puerperium and perinatal conditions
Endometriosis	0/324 (0%)	0	0/319 (0%)	0	0/124 (0%)	0	1/239 (0.4%)	1
Reproductive system and breast disorders
Ovarian cyst ruptured	1/324 (0.3%)	1	0/319 (0%)	0	0/124 (0%)	0	0/239 (0%)	0
Other (Not Including Serious) Adverse Events
	Bremelanotide (Main Study)		Placebo (Main Study)		Bremelanotide (OLE)		Placebo (OLE)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	255/324 (78.7%)		160/319 (50.2%)		95/124 (76.6%)		200/239 (83.7%)
Gastrointestinal disorders
Nausea	138/324 (42.6%)		7/319 (2.2%)		46/124 (37.1%)		109/239 (45.6%)
Vomiting	17/324 (5.2%)		0/319 (0%)		3/124 (2.4%)		15/239 (6.3%)
Abdominal pain upper	7/324 (2.2%)		3/319 (0.9%)		2/124 (1.6%)		5/239 (2.1%)
Diarrhea	7/324 (2.2%)		3/319 (0.9%)		4/124 (3.2%)		7/239 (2.9%)
General disorders
Injection site pain	15/324 (4.6%)		20/319 (6.3%)		3/124 (2.4%)		20/239 (8.4%)
Injection site reaction	18/324 (5.6%)		3/319 (0.9%)		2/124 (1.6%)		14/239 (5.9%)
Fatigue	12/324 (3.7%)		1/319 (0.3%)		4/124 (3.2%)		17/239 (7.1%)
Injection site erythema	8/324 (2.5%)		1/319 (0.3%)		2/124 (1.6%)		2/239 (0.8%)
Injection site pruritus	7/324 (2.2%)		1/319 (0.3%)		2/124 (1.6%)		4/239 (1.7%)
Pain	7/324 (2.2%)		0/319 (0%)		1/124 (0.8%)		6/239 (2.5%)
Infections and infestations
Upper respiratory tract infection	22/324 (6.8%)		25/319 (7.8%)		11/124 (8.9%)		17/239 (7.1%)
Urinary tract infection	13/324 (4%)		21/319 (6.6%)		9/124 (7.3%)		6/239 (2.5%)
Nasopharyngitis	14/324 (4.3%)		6/319 (1.9%)		4/124 (3.2%)		4/239 (1.7%)
Sinusitis	7/324 (2.2%)		10/319 (3.1%)		4/124 (3.2%)		9/239 (3.8%)
Influenza	3/324 (0.9%)		6/319 (1.9%)		4/124 (3.2%)		7/239 (2.9%)
Gastroenteritis Viral	4/324 (1.2%)		7/319 (2.2%)		2/124 (1.6%)		4/239 (1.7%)
Injury, poisoning and procedural complications
Sunburn	10/324 (3.1%)		33/319 (10.3%)		12/124 (9.7%)		33/239 (13.8%)
Musculoskeletal and connective tissue disorders
Arthralgia	5/324 (1.5%)		1/319 (0.3%)		5/124 (4%)		4/239 (1.7%)
Nervous system disorders
Headache	32/324 (9.9%)		8/319 (2.5%)		13/124 (10.5%)		31/239 (13%)
Dizziness	10/324 (3.1%)		1/319 (0.3%)		0/124 (0%)		10/239 (4.2%)
Paresthesia	7/324 (2.2%)		0/319 (0%)		0/124 (0%)		4/239 (1.7%)
Somnolence	1/324 (0.3%)		1/319 (0.3%)		1/124 (0.8%)		6/239 (2.5%)
Respiratory, thoracic and mediastinal disorders
Cough	8/324 (2.5%)		4/319 (1.3%)		2/124 (1.6%)		9/239 (3.8%)
Vascular disorders
Flushing	84/324 (25.9%)		2/319 (0.6%)		24/124 (19.4%)		65/239 (27.2%)
Hot Flush	6/324 (1.9%)		1/319 (0.3%)		3/124 (2.4%)		6/239 (2.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

If there is no multi-site publication within 18 months after the Study has been completed or terminated at all Study sites, and all data have been received by Sponsor, the Site, and SMO shall have the right to publish its results from the Study for non-commercial purposes, if submitted to Sponsor for review 60 days prior to submission of publication. Publication must remove all confidential information and may be delayed by up to 180 days to allow Sponsor to protect its interests.