Trial Outcomes & Findings for 1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (NCT NCT02333071)
NCT ID: NCT02333071
Last Updated: 2021-04-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
723 participants
Primary outcome timeframe
8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)
Results posted on
2021-04-09
Participant Flow
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.
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.
Participant milestones
| Measure |
Placebo PBO/BMT
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)
|
Bremelanotide BMT/BMT
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)
|
|---|---|---|
|
Core Study
STARTED
|
326
|
327
|
|
Core Study
Received Intervention
|
319
|
324
|
|
Core Study
COMPLETED
|
274
|
190
|
|
Core Study
NOT COMPLETED
|
52
|
137
|
|
Open Label Extension
STARTED
|
239
|
124
|
|
Open Label Extension
COMPLETED
|
95
|
49
|
|
Open Label Extension
NOT COMPLETED
|
144
|
75
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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/BMT) group and 239 in the PBO (PBO/BMT) group.
Baseline characteristics by cohort
| Measure |
Bremelanotide (BMT/BMT)
n=324 Participants
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)
|
Placebo (PBO/BMT)
n=319 Participants
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
n=643 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Main
|
38.4 Years
STANDARD_DEVIATION 6.95 • n=324 Participants • 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/BMT) group and 239 in the PBO (PBO/BMT) group.
|
38.5 Years
STANDARD_DEVIATION 7.22 • n=319 Participants • 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/BMT) group and 239 in the PBO (PBO/BMT) group.
|
38.5 Years
STANDARD_DEVIATION 7.08 • n=643 Participants • 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/BMT) group and 239 in the PBO (PBO/BMT) group.
|
|
Age, Continuous
OLE
|
38.5 Years
STANDARD_DEVIATION 6.72 • n=124 Participants • 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/BMT) group and 239 in the PBO (PBO/BMT) group.
|
38.8 Years
STANDARD_DEVIATION 6.93 • n=239 Participants • 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/BMT) group and 239 in the PBO (PBO/BMT) group.
|
38.7 Years
STANDARD_DEVIATION 6.85 • n=363 Participants • 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/BMT) group and 239 in the PBO (PBO/BMT) group.
|
|
Sex: Female, Male
Main · Female
|
324 Participants
n=324 Participants • 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/BMT) group and 239 in the PBO (PBO/BMT) group.
|
319 Participants
n=319 Participants • 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/BMT) group and 239 in the PBO (PBO/BMT) group.
|
643 Participants
n=643 Participants • 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/BMT) group and 239 in the PBO (PBO/BMT) group.
|
|
Sex: Female, Male
Main · Male
|
0 Participants
n=324 Participants • 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/BMT) group and 239 in the PBO (PBO/BMT) group.
|
0 Participants
n=319 Participants • 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/BMT) group and 239 in the PBO (PBO/BMT) group.
|
0 Participants
n=643 Participants • 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/BMT) group and 239 in the PBO (PBO/BMT) group.
|
|
Sex: Female, Male
OLE · Female
|
124 Participants
n=124 Participants • 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/BMT) group and 239 in the PBO (PBO/BMT) group.
|
239 Participants
n=239 Participants • 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/BMT) group and 239 in the PBO (PBO/BMT) group.
|
363 Participants
n=363 Participants • 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/BMT) group and 239 in the PBO (PBO/BMT) group.
|
|
Sex: Female, Male
OLE · Male
|
0 Participants
n=124 Participants • 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/BMT) group and 239 in the PBO (PBO/BMT) group.
|
0 Participants
n=239 Participants • 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/BMT) group and 239 in the PBO (PBO/BMT) group.
|
0 Participants
n=363 Participants • 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/BMT) group and 239 in the PBO (PBO/BMT) group.
|
|
Ethnicity (NIH/OMB)
Main · Hispanic or Latino
|
33 Participants
n=324 Participants • 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/BMT) group and 239 in the PBO (PBO/BMT) group.
|
31 Participants
n=319 Participants • 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/BMT) group and 239 in the PBO (PBO/BMT) group.
|
64 Participants
n=643 Participants • 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/BMT) group and 239 in the PBO (PBO/BMT) group.
|
|
Ethnicity (NIH/OMB)
Main · Not Hispanic or Latino
|
291 Participants
n=324 Participants • 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/BMT) group and 239 in the PBO (PBO/BMT) group.
|
288 Participants
n=319 Participants • 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/BMT) group and 239 in the PBO (PBO/BMT) group.
|
579 Participants
n=643 Participants • 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/BMT) group and 239 in the PBO (PBO/BMT) group.
|
|
Ethnicity (NIH/OMB)
Main · Unknown or Not Reported
|
0 Participants
n=324 Participants • 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/BMT) group and 239 in the PBO (PBO/BMT) group.
|
0 Participants
n=319 Participants • 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/BMT) group and 239 in the PBO (PBO/BMT) group.
|
0 Participants
n=643 Participants • 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/BMT) group and 239 in the PBO (PBO/BMT) group.
|
|
Ethnicity (NIH/OMB)
OLE · Hispanic or Latino
|
13 Participants
n=124 Participants • 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/BMT) group and 239 in the PBO (PBO/BMT) group.
|
20 Participants
n=239 Participants • 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/BMT) group and 239 in the PBO (PBO/BMT) group.
|
33 Participants
n=363 Participants • 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/BMT) group and 239 in the PBO (PBO/BMT) group.
|
|
Ethnicity (NIH/OMB)
OLE · Not Hispanic or Latino
|
111 Participants
n=124 Participants • 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/BMT) group and 239 in the PBO (PBO/BMT) group.
|
219 Participants
n=239 Participants • 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/BMT) group and 239 in the PBO (PBO/BMT) group.
|
330 Participants
n=363 Participants • 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/BMT) group and 239 in the PBO (PBO/BMT) group.
|
|
Ethnicity (NIH/OMB)
OLE · Unknown or Not Reported
|
0 Participants
n=124 Participants • 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/BMT) group and 239 in the PBO (PBO/BMT) group.
|
0 Participants
n=239 Participants • 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/BMT) group and 239 in the PBO (PBO/BMT) group.
|
0 Participants
n=363 Participants • 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/BMT) group and 239 in the PBO (PBO/BMT) group.
|
|
Race (NIH/OMB)
Main · American Indian or Alaska Native
|
3 Participants
n=324 Participants • 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 group and 239 in the PBO group
|
1 Participants
n=319 Participants • 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 group and 239 in the PBO group
|
4 Participants
n=643 Participants • 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 group and 239 in the PBO group
|
|
Race (NIH/OMB)
Main · Asian
|
2 Participants
n=324 Participants • 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 group and 239 in the PBO group
|
3 Participants
n=319 Participants • 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 group and 239 in the PBO group
|
5 Participants
n=643 Participants • 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 group and 239 in the PBO group
|
|
Race (NIH/OMB)
Main · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=324 Participants • 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 group and 239 in the PBO group
|
0 Participants
n=319 Participants • 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 group and 239 in the PBO group
|
0 Participants
n=643 Participants • 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 group and 239 in the PBO group
|
|
Race (NIH/OMB)
Main · Black or African American
|
44 Participants
n=324 Participants • 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 group and 239 in the PBO group
|
42 Participants
n=319 Participants • 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 group and 239 in the PBO group
|
86 Participants
n=643 Participants • 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 group and 239 in the PBO group
|
|
Race (NIH/OMB)
Main · White
|
273 Participants
n=324 Participants • 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 group and 239 in the PBO group
|
269 Participants
n=319 Participants • 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 group and 239 in the PBO group
|
542 Participants
n=643 Participants • 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 group and 239 in the PBO group
|
|
Race (NIH/OMB)
Main · More than one race
|
1 Participants
n=324 Participants • 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 group and 239 in the PBO group
|
3 Participants
n=319 Participants • 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 group and 239 in the PBO group
|
4 Participants
n=643 Participants • 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 group and 239 in the PBO group
|
|
Race (NIH/OMB)
Main · Unknown or Not Reported
|
1 Participants
n=324 Participants • 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 group and 239 in the PBO group
|
1 Participants
n=319 Participants • 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 group and 239 in the PBO group
|
2 Participants
n=643 Participants • 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 group and 239 in the PBO group
|
|
Race (NIH/OMB)
OLE · American Indian or Alaska Native
|
2 Participants
n=124 Participants • 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 group and 239 in the PBO group
|
0 Participants
n=239 Participants • 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 group and 239 in the PBO group
|
2 Participants
n=363 Participants • 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 group and 239 in the PBO group
|
|
Race (NIH/OMB)
OLE · Asian
|
2 Participants
n=124 Participants • 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 group and 239 in the PBO group
|
2 Participants
n=239 Participants • 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 group and 239 in the PBO group
|
4 Participants
n=363 Participants • 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 group and 239 in the PBO group
|
|
Race (NIH/OMB)
OLE · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=124 Participants • 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 group and 239 in the PBO group
|
0 Participants
n=239 Participants • 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 group and 239 in the PBO group
|
0 Participants
n=363 Participants • 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 group and 239 in the PBO group
|
|
Race (NIH/OMB)
OLE · Black or African American
|
17 Participants
n=124 Participants • 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 group and 239 in the PBO group
|
29 Participants
n=239 Participants • 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 group and 239 in the PBO group
|
46 Participants
n=363 Participants • 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 group and 239 in the PBO group
|
|
Race (NIH/OMB)
OLE · White
|
101 Participants
n=124 Participants • 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 group and 239 in the PBO group
|
204 Participants
n=239 Participants • 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 group and 239 in the PBO group
|
305 Participants
n=363 Participants • 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 group and 239 in the PBO group
|
|
Race (NIH/OMB)
OLE · More than one race
|
1 Participants
n=124 Participants • 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 group and 239 in the PBO group
|
3 Participants
n=239 Participants • 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 group and 239 in the PBO group
|
4 Participants
n=363 Participants • 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 group and 239 in the PBO group
|
|
Race (NIH/OMB)
OLE · Unknown or Not Reported
|
1 Participants
n=124 Participants • 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 group and 239 in the PBO group
|
1 Participants
n=239 Participants • 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 group and 239 in the PBO group
|
2 Participants
n=363 Participants • 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 group and 239 in the PBO group
|
PRIMARY outcome
Timeframe: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)Population: 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.
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.
Outcome measures
| Measure |
Bremelanotide BMT/BMT
n=313 Participants
(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)
|
Placebo PBO/BMT
n=315 Participants
(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)
|
|---|---|---|
|
Efficacy of a Fixed Dose of Bremelanotide as Measured by FSFI (Question Q1 and Q2), 28-day Recall.
Main study
|
0.54 score on a scale
Standard Deviation 1.106
|
0.24 score on a scale
Standard Deviation 0.994
|
|
Efficacy of a Fixed Dose of Bremelanotide as Measured by FSFI (Question Q1 and Q2), 28-day Recall.
Open label extension
|
1.30 score on a scale
Standard Deviation 1.105
|
0.77 score on a scale
Standard Deviation 1.138
|
PRIMARY outcome
Timeframe: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)Population: A total of 363 of the 464 (78.2%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase.
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).
Outcome measures
| Measure |
Bremelanotide BMT/BMT
n=313 Participants
(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)
|
Placebo PBO/BMT
n=314 Participants
(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)
|
|---|---|---|
|
Efficacy of a Fixed Dose of Bremelanotide as Measured by FSDS-DAO (Item 13)
Main study
|
-0.73 score on a scale
Standard Deviation 1.203
|
-0.36 score on a scale
Standard Deviation 1.082
|
|
Efficacy of a Fixed Dose of Bremelanotide as Measured by FSDS-DAO (Item 13)
Open label extension
|
-1.7 score on a scale
Standard Deviation 1.21
|
-0.9 score on a scale
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)Population: 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.
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.
Outcome measures
| Measure |
Bremelanotide BMT/BMT
n=314 Participants
(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)
|
Placebo PBO/BMT
n=316 Participants
(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)
|
|---|---|---|
|
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
Open label extension
|
0.28 events
Standard Deviation 1.457
|
0.10 events
Standard Deviation 1.189
|
|
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
Main study
|
0.0 events
Standard Deviation 1.44
|
-0.1 events
Standard Deviation 1.35
|
SECONDARY outcome
Timeframe: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)Population: 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.
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.
Outcome measures
| Measure |
Bremelanotide BMT/BMT
n=314 Participants
(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)
|
Placebo PBO/BMT
n=316 Participants
(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)
|
|---|---|---|
|
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
Main study
|
0.0 score on a scale
Standard Deviation 1.09
|
0.1 score on a scale
Standard Deviation 0.92
|
|
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
Open label extension
|
0.66 score on a scale
Standard Deviation 0.975
|
0.38 score on a scale
Standard Deviation 1.107
|
SECONDARY outcome
Timeframe: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)Population: 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.
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).
Outcome measures
| Measure |
Bremelanotide BMT/BMT
n=314 Participants
(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)
|
Placebo PBO/BMT
n=316 Participants
(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)
|
|---|---|---|
|
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
Main study
|
0.2 score on a scale
Standard Deviation 1.15
|
0.0 score on a scale
Standard Deviation 0.96
|
|
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
Open label extension
|
0.93 score on a scale
Standard Deviation 1.141
|
0.59 score on a scale
Standard Deviation 1.054
|
SECONDARY outcome
Timeframe: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)Population: 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.
FSDS-DAO = Female Sexual Distress Scale - Desire/Arousal/Orgasm Scores range from 0 (never feel bothered) to 60 (always feel bothered).
Outcome measures
| Measure |
Bremelanotide BMT/BMT
n=313 Participants
(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)
|
Placebo PBO/BMT
n=314 Participants
(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)
|
|---|---|---|
|
Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the FSDS-DAO Total Score
Main study
|
-9.2 score on a scale
Standard Deviation 13.86
|
-5.5 score on a scale
Standard Deviation 12.27
|
|
Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the FSDS-DAO Total Score
Open label extension
|
-21.4 score on a scale
Standard Deviation 13.96
|
-12.0 score on a scale
Standard Deviation 13.66
|
SECONDARY outcome
Timeframe: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)Population: 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.
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.
Outcome measures
| Measure |
Bremelanotide BMT/BMT
n=313 Participants
(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)
|
Placebo PBO/BMT
n=315 Participants
(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)
|
|---|---|---|
|
Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Total FSFI Total Score
Main study
|
2.69 score on a scale
Standard Deviation 7.317
|
0.95 score on a scale
Standard Deviation 5.963
|
|
Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Total FSFI Total Score
Open label extension
|
7.71 score on a scale
Standard Deviation 8.076
|
3.95 score on a scale
Standard Deviation 6.740
|
SECONDARY outcome
Timeframe: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)Population: 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.
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.
Outcome measures
| Measure |
Bremelanotide BMT/BMT
n=314 Participants
(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)
|
Placebo PBO/BMT
n=316 Participants
(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)
|
|---|---|---|
|
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
Main study
|
0.1 score on a scale
Standard Deviation 1.11
|
-0.1 score on a scale
Standard Deviation 0.93
|
|
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
Open label extension
|
0.65 score on a scale
Standard Deviation 1.035
|
0.43 score on a scale
Standard Deviation 1.029
|
SECONDARY outcome
Timeframe: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)Population: 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.
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.
Outcome measures
| Measure |
Bremelanotide BMT/BMT
n=314 Participants
(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)
|
Placebo PBO/BMT
n=316 Participants
(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)
|
|---|---|---|
|
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
Main study
|
0.2 score on a scale
Standard Deviation 1.20
|
-0.1 score on a scale
Standard Deviation 1.02
|
|
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
Open label extension
|
0.99 score on a scale
Standard Deviation 1.170
|
0.60 score on a scale
Standard Deviation 1.116
|
SECONDARY outcome
Timeframe: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)Population: 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.
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.
Outcome measures
| Measure |
Bremelanotide BMT/BMT
n=313 Participants
(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)
|
Placebo PBO/BMT
n=314 Participants
(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)
|
|---|---|---|
|
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
Main study
|
-0.6 score on a scale
Standard Deviation 1.24
|
-0.4 score on a scale
Standard Deviation 1.07
|
|
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
Open label extension
|
-1.5 score on a scale
Standard Deviation 1.23
|
-1.0 score on a scale
Standard Deviation 1.12
|
SECONDARY outcome
Timeframe: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)Population: 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.
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.
Outcome measures
| Measure |
Bremelanotide BMT/BMT
n=313 Participants
(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)
|
Placebo PBO/BMT
n=315 Participants
(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)
|
|---|---|---|
|
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)
Main study
|
0.66 score on a scale
Standard Deviation 1.596
|
0.16 score on a scale
Standard Deviation 1.240
|
|
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)
Open label extension
|
1.46 score on a scale
Standard Deviation 1.724
|
1.08 score on a scale
Standard Deviation 1.581
|
SECONDARY outcome
Timeframe: 8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)Population: 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.
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.
Outcome measures
| Measure |
Bremelanotide BMT/BMT
n=314 Participants
(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)
|
Placebo PBO/BMT
n=316 Participants
(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)
|
|---|---|---|
|
Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Total Number of SSEs
Open label extension
|
0.65 events
Standard Deviation 1.676
|
0.05 events
Standard Deviation 1.553
|
|
Efficacy of a Fixed Dose of Bremelanotide, as Measured by a Change From Baseline to End of Study in the Total Number of SSEs
Main study
|
-0.1 events
Standard Deviation 1.76
|
-0.2 events
Standard Deviation 1.79
|
SECONDARY outcome
Timeframe: 24 weeks (Main Study)Population: Number of participants in just the double-blind study. The OLE study was not a double-blind 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.
Outcome measures
| Measure |
Bremelanotide BMT/BMT
n=192 Participants
(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)
|
Placebo PBO/BMT
n=272 Participants
(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)
|
|---|---|---|
|
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
|
0.69 score on a scale
Standard Deviation 1.114
|
0.23 score on a scale
Standard Deviation 0.933
|
SECONDARY outcome
Timeframe: 24 weeks (Main Study)Population: Number of participants in just the double-blind study. The OLE study was not a double-blind 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).
Outcome measures
| Measure |
Bremelanotide BMT/BMT
n=192 Participants
(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)
|
Placebo PBO/BMT
n=271 Participants
(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)
|
|---|---|---|
|
Change From Baseline to End of Study in the Total Score for FSDS-DAO (Item 13) Throughout the Entirety of the Double-blind Phase
|
-0.9 score on a scale
Standard Deviation 1.23
|
-0.3 score on a scale
Standard Deviation 1.05
|
SECONDARY outcome
Timeframe: 24 weeks (Main Study)Population: Number of participants in just the double-blind study. The OLE study was not a double-blind 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.
Outcome measures
| Measure |
Bremelanotide BMT/BMT
n=193 Participants
(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)
|
Placebo PBO/BMT
n=276 Participants
(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)
|
|---|---|---|
|
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
|
0.1 events
Standard Deviation 1.66
|
-0.1 events
Standard Deviation 1.37
|
Adverse Events
Bremelanotide (Main Study)
Serious events: 4 serious events
Other events: 255 other events
Deaths: 0 deaths
Placebo (Main Study)
Serious events: 1 serious events
Other events: 160 other events
Deaths: 0 deaths
Bremelanotide (OLE)
Serious events: 0 serious events
Other events: 95 other events
Deaths: 0 deaths
Placebo (OLE)
Serious events: 2 serious events
Other events: 200 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bremelanotide (Main Study)
n=324 participants at risk
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)
|
Placebo (Main Study)
n=319 participants at risk
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
|
Bremelanotide (OLE)
n=124 participants at risk
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)
|
Placebo (OLE)
n=239 participants at risk
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)
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal hernia obstructive
|
0.31%
1/324 • Number of events 1 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.00%
0/319 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.00%
0/124 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.00%
0/239 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/324 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.31%
1/319 • Number of events 1 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.00%
0/124 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.00%
0/239 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
|
Gastrointestinal disorders
Peritoneal hemorrhage
|
0.31%
1/324 • Number of events 1 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.00%
0/319 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.00%
0/124 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.00%
0/239 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.31%
1/324 • Number of events 1 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.00%
0/319 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.00%
0/124 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.00%
0/239 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.31%
1/324 • Number of events 1 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.00%
0/319 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.00%
0/124 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.00%
0/239 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
|
Nervous system disorders
Headache
|
0.31%
1/324 • Number of events 1 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.00%
0/319 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.00%
0/124 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.00%
0/239 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.31%
1/324 • Number of events 1 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.00%
0/319 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.00%
0/124 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.00%
0/239 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
|
Cardiac disorders
Cerebrovascular accident
|
0.00%
0/324 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.00%
0/319 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.00%
0/124 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.42%
1/239 • Number of events 1 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
|
Pregnancy, puerperium and perinatal conditions
Endometriosis
|
0.00%
0/324 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.00%
0/319 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.00%
0/124 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.42%
1/239 • Number of events 1 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
Other adverse events
| Measure |
Bremelanotide (Main Study)
n=324 participants at risk
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)
|
Placebo (Main Study)
n=319 participants at risk
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
|
Bremelanotide (OLE)
n=124 participants at risk
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)
|
Placebo (OLE)
n=239 participants at risk
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)
|
|---|---|---|---|---|
|
Vascular disorders
Flushing
|
25.9%
84/324 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.63%
2/319 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
19.4%
24/124 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
27.2%
65/239 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
|
Nervous system disorders
Headache
|
9.9%
32/324 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
2.5%
8/319 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
10.5%
13/124 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
13.0%
31/239 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.5%
8/324 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
1.3%
4/319 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
1.6%
2/124 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
3.8%
9/239 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
|
Gastrointestinal disorders
Nausea
|
42.6%
138/324 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
2.2%
7/319 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
37.1%
46/124 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
45.6%
109/239 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
|
Gastrointestinal disorders
Vomiting
|
5.2%
17/324 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.00%
0/319 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
2.4%
3/124 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
6.3%
15/239 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.8%
22/324 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
7.8%
25/319 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
8.9%
11/124 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
7.1%
17/239 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
|
Infections and infestations
Urinary tract infection
|
4.0%
13/324 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
6.6%
21/319 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
7.3%
9/124 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
2.5%
6/239 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
|
Infections and infestations
Nasopharyngitis
|
4.3%
14/324 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
1.9%
6/319 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
3.2%
4/124 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
1.7%
4/239 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
|
Infections and infestations
Sinusitis
|
2.2%
7/324 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
3.1%
10/319 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
3.2%
4/124 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
3.8%
9/239 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
|
General disorders
Injection site pain
|
4.6%
15/324 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
6.3%
20/319 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
2.4%
3/124 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
8.4%
20/239 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
|
General disorders
Injection site reaction
|
5.6%
18/324 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.94%
3/319 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
1.6%
2/124 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
5.9%
14/239 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
|
Injury, poisoning and procedural complications
Sunburn
|
3.1%
10/324 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
10.3%
33/319 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
9.7%
12/124 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
13.8%
33/239 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.2%
7/324 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.94%
3/319 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
1.6%
2/124 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
2.1%
5/239 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
|
Gastrointestinal disorders
Diarrhea
|
2.2%
7/324 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.94%
3/319 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
3.2%
4/124 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
2.9%
7/239 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
|
General disorders
Fatigue
|
3.7%
12/324 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.31%
1/319 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
3.2%
4/124 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
7.1%
17/239 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
|
General disorders
Injection site erythema
|
2.5%
8/324 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.31%
1/319 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
1.6%
2/124 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.84%
2/239 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
|
General disorders
Injection site pruritus
|
2.2%
7/324 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.31%
1/319 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
1.6%
2/124 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
1.7%
4/239 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
|
General disorders
Pain
|
2.2%
7/324 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.00%
0/319 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.81%
1/124 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
2.5%
6/239 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
|
Nervous system disorders
Dizziness
|
3.1%
10/324 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.31%
1/319 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.00%
0/124 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
4.2%
10/239 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
|
Nervous system disorders
Paresthesia
|
2.2%
7/324 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.00%
0/319 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.00%
0/124 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
1.7%
4/239 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
|
Infections and infestations
Influenza
|
0.93%
3/324 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
1.9%
6/319 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
3.2%
4/124 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
2.9%
7/239 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.5%
5/324 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.31%
1/319 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
4.0%
5/124 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
1.7%
4/239 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
|
Vascular disorders
Hot Flush
|
1.9%
6/324 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.31%
1/319 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
2.4%
3/124 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
2.5%
6/239 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
|
Nervous system disorders
Somnolence
|
0.31%
1/324 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.31%
1/319 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
0.81%
1/124 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
2.5%
6/239 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
|
Infections and infestations
Gastroenteritis Viral
|
1.2%
4/324 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
2.2%
7/319 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
1.6%
2/124 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
1.7%
4/239 • 6 months (Main study), 12 months (Open Label study)
Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER