HSDD: 2. 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: NCT02338960
• Collaborator: AMAG Pharmaceuticals, Inc. (Industry)
• Enrollment: 714
• Locations: 91
• Arms: 2
• Duration (Months): 29.9
• Patients Per Site: 7.8
• 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; Drug: 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: 714 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: Jan 1, 2015
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Jun 29, 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 ; Drug: 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 This score is on a scale ranging from 1.2 to 6. A higher score on this scale represent an increase in sexual desire and is a better outcome.

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 (item 13). Responses range from 0 (never) to 4 (always). Lower scores on this scale represent an increase in sexual desire and indicate a better outcome. Higher scores indicate a worse outcome.

Secondary Outcome Measures

1. Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study (EOS) in the Number of Satisfying Sexual Events (SSEs) Associated With Study Drug Administration [8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)]

   Mean change from Baseline to end of study (EOS) in the number of satisfying sexual events (SSEs) that occurred within 16 hours of study drug dosing and reported within 72 hours. An increase in number indicates a better outcome.

2. Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in Mean Desire Score (Q3) From the FSEP-R [8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)]

   FSEP-R=Female Sexual Encounter Profile - Revised Scores on this scale range from 0 (no desire) to 3 (high desire). Scale is derived from a questionnaire (mean desire score) where an increase in value indicates a better outcome.

3. Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in Mean Satisfaction With Desire Score (Q4) From FSEP-R [8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)]

   FSEP-R=Female Sexual Encounter Profile - Revised Scores range from 0 (no desire) to 3 (high desire). Scale is derived from a questionnaire (mean desire score) where a higher score indicates a better outcome.

4. Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in 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. The FSDS-DAO is a validated 15-item self-assessment of sexual feelings and problems. All responses are on a scale ranging from 0 ("never") to 4 ("always"). Total Scores range from 0 (never feel bothered) to 60 (always feel bothered). Decreased scores indicate improvement. A higher score on this scale indicates a worse outcome. The score is the mean change from Baseline observed at EOS (Baseline score - EOS score)

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

   Female Sexual Function Index (FSFI) The score is computed programmatically ] resulting in a score on a scale ranging from 1.2 to 6 (Note: OLE: Open-label extension. Scores range from 2 to 36. An improvement in total FSFI score is an increase from baseline. A higher score on this scale represents an increase in sexual desire and is a better outcome.

6. Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Mean Level of Sexual Arousal (Q6) From the FSEP-R [8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)]

   FSEP-R=Female Sexual Encounter Profile - Revised Scores on this scale range from 0 (no desire) to 3 (high desire) Scale is derived from a questionnaire (mean desire score) where a higher score indicates a better outcome.

7. Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Mean Satisfaction With Sexual Arousal (Q7) From the FSEP-R [8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)]

   FSEP-R=Female Sexual Encounter Profile - Revised Scores range from 0 (no desire) to 3 (high desire) Scale is derived from a questionnaire (mean desire score) where a higher score indicates a better outcome.

8. Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Scored Time Spent Being Concerned by Difficulty With Sexual Arousal (Q14) From the FSDS-DAO [8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)]

   FSDS-DAO = Female Sexual Distress Scale - Desire/Arousal/Orgasm. The FSDS-DAO is a validated 15-item self-assessment of sexual feelings and problems. Scores on this scale range from 0 ("never") to 4 ("always"). Decreased scores indicate improvement. A higher score on this scale indicates a worse outcome.

9. Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Arousal Domain of the FSFI (Q3 to Q6) [8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)]

   Female Sexual Function Index (FSFI) The score is computed programmatically using the algorithm described by Rosen, resulting in a score ranging from 1.2 to 6. Higher scores on this scale represent an increase in sexual desire and is a better outcome.

10. Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in 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. A higher number of events indicates a better outcome.

11. Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Desire Domain of the FSFI (Q1 to Q2) Throughout the Entirety of the Double-blind Phase [24 weeks (Main Study)]

    FSFI = Female Sexual Function Index The score is on a scale ranging from 1.2 to 6. A higher score on this scale represents an increase in sexual desire and is a better outcome.

12. Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Score for Feeling Bothered by Low Sexual Desire as Measured by the FSDS-DAO (Item 13) Throughout the Entirety of the Double-blind Phase [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"). Decreased scores indicate improvement. A higher score indicates a worse outcome.

13. Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Number of SSEs Associated With Study Drug Administration Throughout the Entirety of the Double-blind Phase [24 weeks (Main Study)]

    Mean change from Baseline to EOS in the number of satisfying sexual events SSEs associated with study drug administration throughout the entirety of the double-blind phase. A higher number of events indicates a better outcome.

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 242	Birmingham	Alabama	United States	35242
2	Palatin Clinical Site 218	Phoenix	Arizona	United States	85032
3	Palatin Clinical Site 254	Tucson	Arizona	United States	85712
4	Palatin Clinical Site 207	Hot Springs	Arkansas	United States	71901
5	Palatin Clinical Site 258	Beverly Hills	California	United States	90210
6	Palatin Clinical Site 256	Garden Grove	California	United States	92845
7	Palatin Clinical Site 291	Los Angeles	California	United States	90024
8	Palatin Clinical Site 270	Oakland	California	United States	94612
9	Palatin Clinical Site 210	San Diego	California	United States	92120
10	Palatin Clinical Site 251	San Diego	California	United States	92123
11	Palatin Clinical Site 272	Sherman Oaks	California	United States	91403
12	Palatin Clinical Site 253	Tarzana	California	United States	91356
13	Palatin Clinical Site 212	Denver	Colorado	United States	80209
14	Palatin Clinical Site 219	Denver	Colorado	United States	80220
15	Palatin Clinical Site 243	Lakewood	Colorado	United States	80228
16	Palatin Clinical Site 211	New London	Connecticut	United States	06320
17	Palatin Clinical Site 229	Waterbury	Connecticut	United States	06708
18	Palatin Clinical Site 202	Washington	District of Columbia	United States	20036
19	Palatin Clinical Site 204	Aventura	Florida	United States	33180
20	Palatin Clinical Site 273	Coral Gables	Florida	United States	33134
21	Palatin Clinical Site 203	Fort Myers	Florida	United States	33912
22	Palatin Clinical Site 255	Gainesville	Florida	United States	32607
23	Palatin Clinical Site 266	Gainesville	Florida	United States	32607
24	Palatin Clinical Site 224	Jupiter	Florida	United States	33458
25	Palatin Clinical Site 250	Orlando	Florida	United States	32806
26	Palatin Clinical Site 261	Oviedo	Florida	United States	32765
27	Palatin Clinical Site 260	Pinellas Park	Florida	United States	33781
28	Palatin Clinical Site 236	West Palm Beach	Florida	United States	33409
29	Palatin Clinical Site 248	Alpharetta	Georgia	United States	30005
30	Palatin Clinical Site 263	Atlanta	Georgia	United States	30328
31	Palatin Clinical Site 288	Addison	Illinois	United States	60101
32	Palatin Clinical Site 252	Chicago	Illinois	United States	60640
33	Palatin Clinical Site 201	Chicago	Illinois	United States	60654
34	Palatin Clinical Site 277	Indianapolis	Indiana	United States	46260
35	Palatin Clinical Site 247	Prairie Village	Kansas	United States	66206
36	Palatin Clinical Site 286	Paducah	Kentucky	United States	42003
37	Palatin Clinical Site 279	Lake Charles	Louisiana	United States	70629
38	Palatin Clinical Site 281	Metairie	Louisiana	United States	70002
39	Palatin Clinical Site 257	Annapolis	Maryland	United States	21401
40	Palatin Clinical Site 222	Lutherville	Maryland	United States	21093
41	Palatin Clinical Site 283	Rockville	Maryland	United States	20852
42	Palatin Clinical Site 265	Boston	Massachusetts	United States	02131
43	Palatin Clinical Site 217	New Bedford	Massachusetts	United States	02740
44	Palatin Clinical Site 239	Kalamazoo	Michigan	United States	49009
45	Palatin Clinical Site 245	Saginaw	Michigan	United States	48604
46	Palatin Clinical Site 287	Flowood	Mississippi	United States	39232
47	Palatin Clinical Site 244	Kansas City	Missouri	United States	64114
48	Palatin Clinical Site 280	Saint Louis	Missouri	United States	63043
49	Palatin Clinical Site 220	Lincoln	Nebraska	United States	68510
50	Palatin Clinical Site 290	Berlin	New Jersey	United States	08009
51	Palatin Clinical Site 233	Lawrenceville	New Jersey	United States	08648
52	Palatin Clinical Site 276	Albuquerque	New Mexico	United States	87102
53	Palatin Clinical Site 282	Rochester	New York	United States	14618
54	Palatin Clinical Site 264	Cary	North Carolina	United States	27518
55	Palatin Clinical Site 206	Raleigh	North Carolina	United States	27612
56	Palatin Clinical Site 231	Salisbury	North Carolina	United States	28144
57	Palatin Clinical Site 209	Winston-Salem	North Carolina	United States	27103
58	Palatin Clinical Site 271	Canton	Ohio	United States	44718
59	Palatin Clinical Site 215	Cincinnati	Ohio	United States	45249
60	Palatin Clinical Site 232	Cleveland	Ohio	United States	44122
61	Palatin Clinical Site 246	Columbus	Ohio	United States	43212
62	Palatin Clinical Site 221	Mayfield Heights	Ohio	United States	44124
63	Palatin Clinical Site 289	Tiffin	Ohio	United States	44883
64	Palatin Clinical Site 238	Oklahoma City	Oklahoma	United States	73103
65	Palatin Clinical Site 227	Oklahoma City	Oklahoma	United States	73112
66	Palatin Clinical Site 267	Allentown	Pennsylvania	United States	18104
67	Palatin Clinical Site 234	Philadelphia	Pennsylvania	United States	19114
68	Palatin Clinical Site 240	Pittsburgh	Pennsylvania	United States	15206
69	Palatin Clinical Site 278	Lincoln	Rhode Island	United States	02865
70	Palatin Clinical Site 200	Greer	South Carolina	United States	29650
71	Palatin Clinical Site 259	Moncks Corner	South Carolina	United States	29461
72	Palatin Clinical Site 275	Chattanooga	Tennessee	United States	37403
73	Palatin Clinical Site 216	Jackson	Tennessee	United States	38305
74	Palatin Clinical Site 274	Memphis	Tennessee	United States	38119
75	Palatin Clinical Site 292	Nashville	Tennessee	United States	37201
76	Palatin Clinical Site 235	Arlington	Texas	United States	75230
77	Palatin Clinical Site 230	Austin	Texas	United States	78731
78	Palatin Clinical Site 223	Dallas	Texas	United States	75234
79	Palatin Clinical Site 208	Houston	Texas	United States	77054
80	Palatin Clinical Site 269	Draper	Utah	United States	84020
81	Palatin Clinical Site 228	West Jordan	Utah	United States	84088
82	Palatin Clinical Site 284	Newport News	Virginia	United States	23606
83	Palatin Clinical Site 205	Norfolk	Virginia	United States	23502
84	Palatin Clinical Site 213	Richmond	Virginia	United States	23294
85	Palatin Clinical Site 268	Richmond	Virginia	United States	23298
86	Palatin Clinical Site 214	Seattle	Washington	United States	98105
87	Palatin Clinical Site 285	Charleston	West Virginia	United States	25304
88	Palatin Clinical Site 400	Vancouver	British Columbia	Canada	V6J 1S3
89	Palatin Clinical Site 405	Sudbury	Ontario	Canada	P3E 1H5
90	Palatin Clinical Site 401	Pointe Claire	Quebec	Canada	H9R 4S3
91	Palatin Clinical Site 404	Sherbrooke	Quebec	Canada	J1H 121

Sponsors and Collaborators

• Palatin Technologies, Inc
• AMAG Pharmaceuticals, 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: NCT02338960
• Other Study ID Numbers: BMT-302; Reconnect Study
• First Posted: Jan 15, 2015
• Last Update Posted: Jan 28, 2021
• Last Verified: Dec 1, 2020

• Keywords provided by Palatin Technologies, Inc: HSDD Female; Sexual Desire Disorder; decreased desire; female sexual dysfunction
• 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: 703 participants enrolled, 89 run-in failures 614 participants were randomized. OLE Study (optional): Of the 392 completers of the Core study, 321 participants enrolled in optional OLE study. The OLE Study was not reported.

Arm/Group Title	Placebo PBO/BMT	Brememlanotide 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	306	308
Received Intervention	303	301
COMPLETED	219	173
NOT COMPLETED	87	135
Period Title: Core Study
STARTED	191	130
COMPLETED	77	51
NOT COMPLETED	114	79

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	303	301	604
Age (years) [Mean (Standard Deviation) ]
Main	38.5 (7.19)	39.1 (6.96)	38.8 (7.08)
OLE	39.8 (7.12)	39.4 (6.54)	39.6 (6.77)
Sex: Female, Male (Count of Participants)
Female	303 100%	301 100%	604 100%
Male	0 0%	0 0%	0 0%
Female	130 42.9%	191 63.5%	321 53.1%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	21 6.9%	21 7%	42 7%
Not Hispanic or Latino	282 93.1%	280 93%	562 93%
Unknown or Not Reported	0 0%	0 0%	0 0%
Hispanic or Latino	6 2%	9 3%	15 2.5%
Not Hispanic or Latino	124 40.9%	182 60.5%	306 50.7%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 0.7%	1 0.3%	3 0.5%
Asian	5 1.7%	4 1.3%	9 1.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	29 9.6%	29 9.6%	58 9.6%
White	263 86.8%	262 87%	525 86.9%
More than one race	3 1%	2 0.7%	5 0.8%
Unknown or Not Reported	1 0.3%	3 1%	4 0.7%
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 0.3%	2 0.7%	3 0.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	10 3.3%	15 5%	25 4.1%
White	117 38.6%	171 56.8%	288 47.7%
More than one race	2 0.7%	2 0.7%	4 0.7%
Unknown or Not Reported	0 0%	1 0.3%	1 0.2%

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 This score is on a scale ranging from 1.2 to 6. A higher score on this scale represent an increase in sexual desire and is a better outcome.
Time Frame	8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

Outcome Measure Data

Analysis Population Description

A total 321 of the 392 (81.9%) 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	282	288
Main study	0.63 (1.036)	0.21 (0.922)
Open label extension	1.25 (1.158)	0.70 (1.220)

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 (item 13). Responses range from 0 (never) to 4 (always). Lower scores on this scale represent an increase in sexual desire and indicate a better outcome. Higher scores indicate a worse outcome.
Time Frame	8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

Outcome Measure Data

Analysis Population Description

A total 321 of the 392 (81.9%) 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	282	288
Main study	-0.71 (1.145)	-0.42 (1.047)
Open label extension	-1.4 (1.20)	-0.9 (1.07)

3. Secondary Outcome

Title	Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study (EOS) in the Number of Satisfying Sexual Events (SSEs) Associated With Study Drug Administration
Description	Mean change from Baseline to end of study (EOS) in the number of satisfying sexual events (SSEs) that occurred within 16 hours of study drug dosing and reported within 72 hours. An increase in number indicates a better outcome.
Time Frame	8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

Outcome Measure Data

Analysis Population Description

A total 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 128 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	282	290
Main study	0.0 (1.34)	0.0 (1.20)
Open label extension	0.19 (1.997)	-0.31 (1.296)

4. Secondary Outcome

Title	Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in Mean Desire Score (Q3) From the FSEP-R
Description	FSEP-R=Female Sexual Encounter Profile - Revised Scores on this scale range from 0 (no desire) to 3 (high desire). Scale is derived from a questionnaire (mean desire score) where an increase in value indicates a better outcome.
Time Frame	8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

Outcome Measure Data

Analysis Population Description

A total 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 128 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	282	290
Main study	0.04 (1.065)	0.01 (0.928)
Open label extension	0.43 (1.095)	0.33 (1.023)

5. Secondary Outcome

Title	Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in Mean Satisfaction With Desire Score (Q4) From FSEP-R
Description	FSEP-R=Female Sexual Encounter Profile - Revised Scores range from 0 (no desire) to 3 (high desire). Scale is derived from a questionnaire (mean desire score) where a higher score indicates a better outcome.
Time Frame	8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

Outcome Measure Data

Analysis Population Description

A total 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 128 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	282	290
Main study	0.27 (1.077)	0.11 (0.977)
Open label extension	0.76 (1.127)	0.47 (1.075)

6. Secondary Outcome

Title	Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the FSDS-DAO Total Score
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. All responses are on a scale ranging from 0 ("never") to 4 ("always"). Total Scores range from 0 (never feel bothered) to 60 (always feel bothered). Decreased scores indicate improvement. A higher score on this scale indicates a worse outcome. The score is the mean change from Baseline observed at EOS (Baseline score - EOS score)
Time Frame	8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

Outcome Measure Data

Analysis Population Description

A total 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 128 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	282	285
Main study	-9.7 (13.79)	-5.6 (12.06)
Open label extension	-18.4 (14.06)	-11.1 (14.37)

7. Secondary Outcome

Title	Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the FSFI Total Score
Description	Female Sexual Function Index (FSFI) The score is computed programmatically ] resulting in a score on a scale ranging from 1.2 to 6 (Note: OLE: Open-label extension. Scores range from 2 to 36. An improvement in total FSFI score is an increase from baseline. A higher score on this scale represents an increase in sexual desire and is a better outcome.
Time Frame	8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

Outcome Measure Data

Analysis Population Description

A total 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 128 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	282	288
Main study	2.45 (7.383)	0.84 (5.879)
Open label extension	5.15 (7.301)	3.14 (7.281)

8. Secondary Outcome

Title	Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Mean Level of Sexual Arousal (Q6) From the FSEP-R
Description	FSEP-R=Female Sexual Encounter Profile - Revised Scores on this scale range from 0 (no desire) to 3 (high desire) Scale is derived from a questionnaire (mean desire score) where a higher score indicates a better outcome.
Time Frame	8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

Outcome Measure Data

Analysis Population Description

A total 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 128 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	282	290
Main study	0.04 (1.068)	-0.01 (0.906)
Open label extension	0.33 (0.987)	0.35 (0.994)

9. Secondary Outcome

Title	Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Mean Satisfaction With Sexual Arousal (Q7) From the FSEP-R
Description	FSEP-R=Female Sexual Encounter Profile - Revised Scores range from 0 (no desire) to 3 (high desire) Scale is derived from a questionnaire (mean desire score) where a higher score indicates a better outcome.
Time Frame	8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

Outcome Measure Data

Analysis Population Description

A total 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 128 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	282	290
Main study	0.23 (1.112)	0.09 (0.974)
Open label extension	0.60 (1.107)	0.47 (1.102)

10. Secondary Outcome

Title	Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Scored Time Spent Being Concerned by Difficulty With Sexual Arousal (Q14) From the FSDS-DAO
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. Scores on this scale range from 0 ("never") to 4 ("always"). Decreased scores indicate improvement. A higher score on this scale indicates a worse outcome.
Time Frame	8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

Outcome Measure Data

Analysis Population Description

A total 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 128 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	282	285
Main study	-0.8 (1.23)	-0.4 (1.11)
Open label extension	-1.3 (1.11)	-0.9 (1.17)

11. Secondary Outcome

Title	Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Arousal Domain of the FSFI (Q3 to Q6)
Description	Female Sexual Function Index (FSFI) The score is computed programmatically using the algorithm described by Rosen, resulting in a score ranging from 1.2 to 6. Higher scores on this scale represent an increase in sexual desire and is a better outcome.
Time Frame	8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)

Outcome Measure Data

Analysis Population Description

A total 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 128 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	282	288
Main study	0.52 (1.535)	0.18 (1.254)
Open label extension	1.19 (1.560)	0.83 (1.563)

12. Secondary Outcome

Title	Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in 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. A higher number of events 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 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 128 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	282	290
Main study	0.0 (1.34)	-0.0 (1.20)
Open label extension	0.25 (2.376)	-0.35 (1.655)

13. Secondary Outcome

Title	Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Desire Domain of the FSFI (Q1 to Q2) Throughout the Entirety of the Double-blind Phase
Description	FSFI = Female Sexual Function Index The score is on a scale ranging from 1.2 to 6. A higher score on this scale represents an increase in sexual desire and is a better outcome.
Time Frame	24 weeks (Main Study)

Outcome Measure Data

Analysis Population Description

Completed double-blind study of Main study. 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	173	219
Mean (Standard Deviation) [score on a scale]	0.78 (1.052)	0.16 (0.909)

14. Secondary Outcome

Title	Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Score for Feeling Bothered by Low Sexual Desire as Measured by the FSDS-DAO (Item 13) Throughout the Entirety of the Double-blind Phase
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"). Decreased scores indicate improvement. A higher score indicates a worse outcome.
Time Frame	24 weeks (Main Study)

Outcome Measure Data

Analysis Population Description

Completed double-blind study of Main study. OLE study wan not a double blind study.

Arm/Group Title	Bremelanotide BMT	Placebo PBO
Arm/Group Description	(Main 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. 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	173	218
Mean (Standard Deviation) [score on a scale]	-0.8 (1.22)	-0.4 (1.02)

15. 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 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 associated with study drug administration throughout the entirety of the double-blind phase. A higher number of events indicates a better outcome.
Time Frame	24 weeks (Main Study)

Outcome Measure Data

Analysis Population Description

Completed double-blind study of Main study. OLE study wan not a double blind study.

Arm/Group Title	Bremelanotide BMT	Placebo PBO
Arm/Group Description	(Main 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. 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	177	221
Mean (Standard Deviation) [events]	0.1 (1.37)	-0.1 (1.28)

Adverse Events

Time Frame	1 year
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 of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours. 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 of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours. 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. 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	0/303 (0%)		0/301 (0%)		0/130 (0%)		0/191 (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	3/303 (1%)		2/301 (0.7%)		1/130 (0.8%)		0/191 (0%)
Blood and lymphatic system disorders
Anemia	0/303 (0%)		1/301 (0.3%)		0/130 (0%)		0/191 (0%)
Gastrointestinal disorders
Abdominal Pain	1/303 (0.3%)		0/301 (0%)		0/130 (0%)		0/191 (0%)
Gastrointestinal inflammation	1/303 (0.3%)		0/301 (0%)		0/130 (0%)		0/191 (0%)
Hepatobiliary disorders
cholecystitis	0/303 (0%)		0/301 (0%)		1/130 (0.8%)		0/191 (0%)
Infections and infestations
Pneumonia	1/303 (0.3%)		0/301 (0%)		0/130 (0%)		0/191 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer	1/303 (0.3%)		1/301 (0.3%)		0/130 (0%)		0/191 (0%)
Uterine leiomyoma	1/303 (0.3%)		0/301 (0%)		0/130 (0%)		0/191 (0%)
Pregnancy, puerperium and perinatal conditions
Pregnancy	0/303 (0%)		1/301 (0.3%)		0/130 (0%)		0/191 (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	224/303 (73.9%)		137/301 (45.5%)		93/130 (71.5%)		142/191 (74.3%)
Gastrointestinal disorders
Nausea	111/303 (36.6%)		0/301 (0%)		37/130 (28.5%)		84/191 (44%)
Vomiting	13/303 (4.3%)		1/301 (0.3%)		3/130 (2.3%)		9/191 (4.7%)
Abdominal pain	5/303 (1.7%)		1/301 (0.3%)		1/130 (0.8%)		5/191 (2.6%)
Abdominal discomfort	1/303 (0.3%)		1/301 (0.3%)		4/130 (3.1%)		1/191 (0.5%)
General disorders
Injection site pain	21/303 (6.9%)		17/301 (5.6%)		2/130 (1.5%)		5/191 (2.6%)
Injection site reaction	16/303 (5.3%)		0/301 (0%)		4/130 (3.1%)		5/191 (2.6%)
Injection site erythema	10/303 (3.3%)		0/301 (0%)		2/130 (1.5%)		3/191 (1.6%)
Fatigue	8/303 (2.6%)		2/301 (0.7%)		3/130 (2.3%)		5/191 (2.6%)
Injection site hematoma	7/303 (2.3%)		4/301 (1.3%)		0/130 (0%)		4/191 (2.1%)
Influenza like illness	2/303 (0.7%)		0/301 (0%)		2/130 (1.5%)		3/191 (1.6%)
Infections and infestations
Sinusitis	14/303 (4.6%)		13/301 (4.3%)		4/130 (3.1%)		9/191 (4.7%)
Upper respiratory tract infection	12/303 (4%)		13/301 (4.3%)		5/130 (3.8%)		7/191 (3.7%)
Urinary tract infection	10/303 (3.3%)		9/301 (3%)		4/130 (3.1%)		11/191 (5.8%)
Nasopharyngitis	9/303 (3%)		18/301 (6%)		4/130 (3.1%)		10/191 (5.2%)
Bronchitis	5/303 (1.7%)		4/301 (1.3%)		4/130 (3.1%)		2/191 (1%)
Fungal infection	4/303 (1.3%)		4/301 (1.3%)		2/130 (1.5%)		4/191 (2.1%)
Vulvovaginal mycotic infection	5/303 (1.7%)		5/301 (1.7%)		0/130 (0%)		6/191 (3.1%)
Injury, poisoning and procedural complications
Sunburn	16/303 (5.3%)		28/301 (9.3%)		22/130 (16.9%)		25/191 (13.1%)
Investigations
Blood creatine phophokinase	4/303 (1.3%)		0/301 (0%)		0/130 (0%)		4/191 (2.1%)
Musculoskeletal and connective tissue disorders
Myalgia	6/303 (2%)		1/301 (0.3%)		1/130 (0.8%)		6/191 (3.1%)
Nervous system disorders
Headache	38/303 (12.5%)		4/301 (1.3%)		9/130 (6.9%)		29/191 (15.2%)
Paresthesia	9/303 (3%)		0/301 (0%)		1/130 (0.8%)		4/191 (2.1%)
Dizziness	4/303 (1.3%)		2/301 (0.7%)		0/130 (0%)		5/191 (2.6%)
Migraine	0/303 (0%)		2/301 (0.7%)		3/130 (2.3%)		2/191 (1%)
Psychiatric disorders
Insomnia	2/303 (0.7%)		3/301 (1%)		0/130 (0%)		4/191 (2.1%)
Depression	0/303 (0%)		1/301 (0.3%)		3/130 (2.3%)		0/191 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	13/303 (4.3%)		4/301 (1.3%)		3/130 (2.3%)		7/191 (3.7%)
Skin and subcutaneous tissue disorders
Dermatitis contact	1/303 (0.3%)		0/301 (0%)		1/130 (0.8%)		4/191 (2.1%)
Erythema	2/303 (0.7%)		0/301 (0%)		0/130 (0%)		4/191 (2.1%)
Vascular disorders
Flushing	43/303 (14.2%)		0/301 (0%)		11/130 (8.5%)		41/191 (21.5%)
Hot flush	11/303 (3.6%)		0/301 (0%)		0/130 (0%)		8/191 (4.2%)

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.