Trial Outcomes & Findings for Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder (NCT NCT01382719)
NCT ID: NCT01382719
Last Updated: 2014-12-18
Results Overview
The primary efficacy endpoint is change from baseline to end of study in the number of satisfying sexual events (SSEs), computed as the number of events during the last 4 weeks of treatment with FSEP-R Q10 = "Yes" minus the number of baseline events with FSEP-R Q10 = "Yes." Efficacy analyses were done with the MITT population which consisted of all randomized subjects who took at least 1 dose of double-blind treatment after the 2 in-clinic doses of double-blind medication and who had at least 1 follow-up visit (Visit 10 or later) to ensure that FSEP-R data were reviewed and confirmed by the investigative site.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
612 participants
Primary outcome timeframe
4 - 12 weeks from baseline to end of study (total study duration 20 weeks). Baseline was the 4-week single-blind placebo period.
Results posted on
2014-12-18
Participant Flow
A total of 1142 subjects were screened at 69 medical sites in the US and Canada, 612 subjects were enrolled, and 488 subjects entered the single-blind placebo treatment period; 397 were randomized, and 394 were dosed with randomized treatment.
A total of 91 subjects were not randomized due to failing the resting blood pressure criteria (36), withdrawal of consent (24), being lost to follow-up (9), adverse events (5), non-compliance (5), and other reasons (12).
Participant milestones
| Measure |
Placebo
identical formulation without active ingredient
|
Bremelanotide Arm 1
low dose 0.75 mg BMT
|
Bremelanotide Arm 2
middle dose 1.25 mg BMT
|
Bremelanotide Arm 3
high dose 1.75 mg BMT
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
98
|
100
|
100
|
99
|
|
Overall Study
Subjects Not Dosed
|
1
|
0
|
1
|
1
|
|
Overall Study
COMPLETED
|
80
|
81
|
66
|
66
|
|
Overall Study
NOT COMPLETED
|
18
|
19
|
34
|
33
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder
Baseline characteristics by cohort
| Measure |
Placebo
n=97 Participants
identical formulation without active ingredient
|
Bremelanotide Arm 1
n=100 Participants
low dose 0.75 mg BMT
|
Bremelanotide Arm 2
n=99 Participants
middle dose 1.25 mg BMT
|
Bremelanotide Arm 3
n=98 Participants
high dose 1.75 mg BMT
|
Total
n=394 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
37.0 years
STANDARD_DEVIATION 7.70 • n=5 Participants
|
37.6 years
STANDARD_DEVIATION 7.76 • n=7 Participants
|
35.7 years
STANDARD_DEVIATION 7.22 • n=5 Participants
|
37.0 years
STANDARD_DEVIATION 7.56 • n=4 Participants
|
36.9 years
STANDARD_DEVIATION 7.57 • n=21 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
394 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
19 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
99 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
75 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
281 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Weight
|
164.40 Pound
STANDARD_DEVIATION 42.050 • n=5 Participants
|
168.17 Pound
STANDARD_DEVIATION 37.867 • n=7 Participants
|
173.97 Pound
STANDARD_DEVIATION 43.229 • n=5 Participants
|
179.15 Pound
STANDARD_DEVIATION 45.872 • n=4 Participants
|
171.41 Pound
STANDARD_DEVIATION 42.532 • n=21 Participants
|
|
Body Mass Index
|
27.73 kg/m2
STANDARD_DEVIATION 6.171 • n=5 Participants
|
28.47 kg/m2
STANDARD_DEVIATION 6.616 • n=7 Participants
|
29.17 kg/m2
STANDARD_DEVIATION 7.096 • n=5 Participants
|
29.92 kg/m2
STANDARD_DEVIATION 7.181 • n=4 Participants
|
28.82 kg/m2
STANDARD_DEVIATION 6.802 • n=21 Participants
|
|
Of Childbearing Potential
Of Childbearing Potential
|
72 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
283 Participants
n=21 Participants
|
|
Of Childbearing Potential
Surgically Sterile
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
110 Participants
n=21 Participants
|
|
Of Childbearing Potential
Data Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Weight Quartile
95 - 143 pounds
|
37 Pound
n=5 Participants
|
21 Pound
n=7 Participants
|
23 Pound
n=5 Participants
|
21 Pound
n=4 Participants
|
102 Pound
n=21 Participants
|
|
Weight Quartile
>143 - 165 pounds
|
18 Pound
n=5 Participants
|
36 Pound
n=7 Participants
|
25 Pound
n=5 Participants
|
24 Pound
n=4 Participants
|
103 Pound
n=21 Participants
|
|
Weight Quartile
>165 - 200.6 pounds
|
23 Pound
n=5 Participants
|
26 Pound
n=7 Participants
|
28 Pound
n=5 Participants
|
24 Pound
n=4 Participants
|
101 Pound
n=21 Participants
|
|
Weight Quartile
>200.6 - 350 pounds
|
19 Pound
n=5 Participants
|
17 Pound
n=7 Participants
|
23 Pound
n=5 Participants
|
28 Pound
n=4 Participants
|
87 Pound
n=21 Participants
|
|
Weight Quartile
Data Missing
|
0 Pound
n=5 Participants
|
0 Pound
n=7 Participants
|
0 Pound
n=5 Participants
|
1 Pound
n=4 Participants
|
1 Pound
n=21 Participants
|
|
Menses Frequency
Variable cycle length (<7 days different from nor
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Menses Frequency
Regular
|
72 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
312 Participants
n=21 Participants
|
|
Menses Frequency
Variable cycle length (>7 days different from nor
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Menses Frequency
2 or more skipped cycles, and amenorrhea for 60 or
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Menses Frequency
N.A.
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
|
Natural Hair Color
Red
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Natural Hair Color
Other Than Red
|
91 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
371 Participants
n=21 Participants
|
|
Diagnosis
FSAD
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Diagnosis
HSDD
|
24 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
92 Participants
n=21 Participants
|
|
Diagnosis
Mixed FSAD/HSDD
|
69 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
290 Participants
n=21 Participants
|
|
Oral Contraceptive Use within 30 Days of Visit 1
Yes
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
|
Oral Contraceptive Use within 30 Days of Visit 1
No
|
85 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
341 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 4 - 12 weeks from baseline to end of study (total study duration 20 weeks). Baseline was the 4-week single-blind placebo period.The primary efficacy endpoint is change from baseline to end of study in the number of satisfying sexual events (SSEs), computed as the number of events during the last 4 weeks of treatment with FSEP-R Q10 = "Yes" minus the number of baseline events with FSEP-R Q10 = "Yes." Efficacy analyses were done with the MITT population which consisted of all randomized subjects who took at least 1 dose of double-blind treatment after the 2 in-clinic doses of double-blind medication and who had at least 1 follow-up visit (Visit 10 or later) to ensure that FSEP-R data were reviewed and confirmed by the investigative site.
Outcome measures
| Measure |
Placebo
n=91 Participants
identical formulation without active ingredient
|
Bremelanotide Arm 1
n=87 Participants
low dose 0.75 mg BMT
|
Bremelanotide Arm 2
n=75 Participants
middle dose 1.25 mg BMT
|
Bremelanotide Arm 3
n=74 Participants
high dose 1.75 mg BMT
|
|---|---|---|---|---|
|
The Primary Efficacy Endpoint is Change From Baseline to End of Study in the Number of Satisfying Sexual Events (SSE)
|
0.2 SSEs
Standard Deviation 2.29
|
0.6 SSEs
Standard Deviation 3.55
|
0.7 SSEs
Standard Deviation 1.81
|
0.8 SSEs
Standard Deviation 2.86
|
SECONDARY outcome
Timeframe: 4-12 weeks from baseline to end of study (total study duration 20 weeks)The FSFI is brief self-report questionnaire that measures female sexual function. The change from baseline to end of study in the arousal domain were obtained from the FSFI Q3 through Q6. The score range is 0-5. For each of the 2 time points, the score was computed programmatically using the algorithm described by Rosen \[6\], resulting in a score from 0 (min) to 6 (max).
Outcome measures
| Measure |
Placebo
n=91 Participants
identical formulation without active ingredient
|
Bremelanotide Arm 1
n=87 Participants
low dose 0.75 mg BMT
|
Bremelanotide Arm 2
n=75 Participants
middle dose 1.25 mg BMT
|
Bremelanotide Arm 3
n=74 Participants
high dose 1.75 mg BMT
|
|---|---|---|---|---|
|
Change From Baseline to End-of-Study in Arousal Domain Score From Female Sexual Function Index
|
0.51 units on a scale
Standard Deviation 1.371
|
0.35 units on a scale
Standard Deviation 1.457
|
0.71 units on a scale
Standard Deviation 1.112
|
1.06 units on a scale
Standard Deviation 1.146
|
SECONDARY outcome
Timeframe: 4-12 weeks from baseline to end of study (total study duration 20 weeks)This is the change in Baseline to End-of-Study in Satisfaction with Arousal as measured by GAQ Question 1. GAQ (Global Assessment Questions) is a questionnaire that evaluates overall satisfaction level experienced while using the study drug. Question 1 is "Compared to the start of the study (prior to taking the study drug), how would you describe your satisfaction with your arousal while using the study drug?" The score range is 1 (very much worse) to 7 (very much better).
Outcome measures
| Measure |
Placebo
n=91 Participants
identical formulation without active ingredient
|
Bremelanotide Arm 1
n=87 Participants
low dose 0.75 mg BMT
|
Bremelanotide Arm 2
n=75 Participants
middle dose 1.25 mg BMT
|
Bremelanotide Arm 3
n=74 Participants
high dose 1.75 mg BMT
|
|---|---|---|---|---|
|
Satisfaction With Arousal as Measured by GAQ Question 1
|
0.4 units on a scale
Standard Deviation 1.37
|
0.3 units on a scale
Standard Deviation 1.43
|
0.5 units on a scale
Standard Deviation 1.46
|
0.9 units on a scale
Standard Deviation 1.18
|
SECONDARY outcome
Timeframe: 4-12 weeks from baseline to end of study (total study duration 20 weeks)The FSFI is brief self-report questionnaire that measures female sexual function. The change from baseline to end of study in the desire domain were obtained from the FSFI Q1 and Q2. The score range is 1-5. For each of the 2 time points, the score was computed programmatically using the algorithm described by Rosen \[6\], resulting in a score from 0 (min) to 6 (max).
Outcome measures
| Measure |
Placebo
n=91 Participants
identical formulation without active ingredient
|
Bremelanotide Arm 1
n=87 Participants
low dose 0.75 mg BMT
|
Bremelanotide Arm 2
n=75 Participants
middle dose 1.25 mg BMT
|
Bremelanotide Arm 3
n=74 Participants
high dose 1.75 mg BMT
|
|---|---|---|---|---|
|
Desire Domain From Female Sexual Function Index
|
0.39 units on a scale
Standard Deviation 1.075
|
0.33 units on a scale
Standard Deviation 1.093
|
0.55 units on a scale
Standard Deviation 0.794
|
0.95 units on a scale
Standard Deviation 1.003
|
SECONDARY outcome
Timeframe: 4-12 weeks from baseline to end of study (total study duration 20 weeks)This is the change in Baseline to End-of-Study in Satisfaction with Desire as Measured by GAQ Question 2. GAQ (Global Assessment Questions) is a questionnaire that evaluates overall satisfaction level experienced while using the study drug. Question 2 is "Compared to the start of the study (prior to taking the study drug), how would you describe your satisfaction with your desire while using the study drug?" The score range is 1 (very much worse) to 7 (very much better).
Outcome measures
| Measure |
Placebo
n=91 Participants
identical formulation without active ingredient
|
Bremelanotide Arm 1
n=87 Participants
low dose 0.75 mg BMT
|
Bremelanotide Arm 2
n=75 Participants
middle dose 1.25 mg BMT
|
Bremelanotide Arm 3
n=74 Participants
high dose 1.75 mg BMT
|
|---|---|---|---|---|
|
Satisfaction With Desire as Measured by GAQ Question 2
|
0.4 units on a scale
Standard Deviation 1.31
|
0.3 units on a scale
Standard Deviation 1.32
|
0.8 units on a scale
Standard Deviation 1.44
|
0.9 units on a scale
Standard Deviation 1.20
|
SECONDARY outcome
Timeframe: 4-12 weeks from baseline to end of study (total study duration 20 weeks)This is the change in Baseline to End-of-Study in Quality of Relationship with Partner as Measured by GAQ Question 4. GAQ (Global Assessment Questions) is a questionnaire that evaluates overall satisfaction level experienced while using the study drug. Question 4 is "Compared to the start of the study (prior to taking the study drug), how has taking the study drug changed your relationship with your partner?" The score range is 1 (very much worse) to 7 (very much better).
Outcome measures
| Measure |
Placebo
n=91 Participants
identical formulation without active ingredient
|
Bremelanotide Arm 1
n=87 Participants
low dose 0.75 mg BMT
|
Bremelanotide Arm 2
n=75 Participants
middle dose 1.25 mg BMT
|
Bremelanotide Arm 3
n=74 Participants
high dose 1.75 mg BMT
|
|---|---|---|---|---|
|
Quality of Relationship With Partner as Measured by GAQ Question 4
|
0.3 units on a scale
Standard Deviation 1.20
|
0.3 units on a scale
Standard Deviation 1.24
|
0.4 units on a scale
Standard Deviation 1.22
|
0.6 units on a scale
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: 4 - 12 weeks from baseline to end of study (total study duration 20 weeks)FSDS-DAO (Female Sexual Distress Scale - Desire/Arousal/Orgasm) is an assessment tool to measure female sexual distress. The change from baseline to end of study in the FSDS-DAO (total score) was measured. There are 15 questions, eg, "How often do you feel: Distressed about your sex life" and the score range was 0 (Never), 1 (Rarely), 2 (Occasionally), 3 (Frequently), 4 (Always). The score for each subject at each time point was computed as the sum of the scores from the 15 questions, resulting in a possible score at each time point between 0 and 60.
Outcome measures
| Measure |
Placebo
n=91 Participants
identical formulation without active ingredient
|
Bremelanotide Arm 1
n=87 Participants
low dose 0.75 mg BMT
|
Bremelanotide Arm 2
n=75 Participants
middle dose 1.25 mg BMT
|
Bremelanotide Arm 3
n=74 Participants
high dose 1.75 mg BMT
|
|---|---|---|---|---|
|
FSDS-DAO Total Score
|
-6.8 units on a scale
Standard Deviation 13.57
|
-7.4 units on a scale
Standard Deviation 13.47
|
-9.2 units on a scale
Standard Deviation 10.79
|
-13.1 units on a scale
Standard Deviation 12.93
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 49 other events
Deaths: 0 deaths
Bremelanotide Arm 1
Serious events: 1 serious events
Other events: 64 other events
Deaths: 0 deaths
Bremelanotide Arm 2
Serious events: 1 serious events
Other events: 61 other events
Deaths: 0 deaths
Bremelanotide Arm 3
Serious events: 1 serious events
Other events: 67 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=97 participants at risk
identical formulation without active ingredient
|
Bremelanotide Arm 1
n=100 participants at risk
low dose 0.75 mg BMT
|
Bremelanotide Arm 2
n=99 participants at risk
middle dose 1.25 mg BMT
|
Bremelanotide Arm 3
n=98 participants at risk
high dose 1.75 mg BMT
|
|---|---|---|---|---|
|
Infections and infestations
Escherichia bacteremia
|
1.0%
1/97 • Number of events 1
|
0.00%
0/100
|
0.00%
0/99
|
0.00%
0/98
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.0%
1/97 • Number of events 1
|
0.00%
0/100
|
0.00%
0/99
|
0.00%
0/98
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
1.0%
1/97 • Number of events 1
|
0.00%
0/100
|
0.00%
0/99
|
0.00%
0/98
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/97
|
1.0%
1/100 • Number of events 1
|
0.00%
0/99
|
0.00%
0/98
|
|
Surgical and medical procedures
Incisional hernia
|
0.00%
0/97
|
0.00%
0/100
|
1.0%
1/99 • Number of events 1
|
0.00%
0/98
|
|
Cardiac disorders
Chest pain
|
0.00%
0/97
|
0.00%
0/100
|
0.00%
0/99
|
1.0%
1/98 • Number of events 1
|
Other adverse events
| Measure |
Placebo
n=97 participants at risk
identical formulation without active ingredient
|
Bremelanotide Arm 1
n=100 participants at risk
low dose 0.75 mg BMT
|
Bremelanotide Arm 2
n=99 participants at risk
middle dose 1.25 mg BMT
|
Bremelanotide Arm 3
n=98 participants at risk
high dose 1.75 mg BMT
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
3.1%
3/97 • Number of events 3
|
18.0%
18/100 • Number of events 34
|
22.2%
22/99 • Number of events 63
|
24.5%
24/98 • Number of events 51
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/97
|
2.0%
2/100 • Number of events 2
|
4.0%
4/99 • Number of events 6
|
6.1%
6/98 • Number of events 11
|
|
General disorders
Injection site pain
|
3.1%
3/97 • Number of events 6
|
6.0%
6/100 • Number of events 8
|
6.1%
6/99 • Number of events 10
|
7.1%
7/98 • Number of events 9
|
|
General disorders
Injection site pruritus
|
0.00%
0/97
|
4.0%
4/100 • Number of events 6
|
4.0%
4/99 • Number of events 7
|
6.1%
6/98 • Number of events 7
|
|
General disorders
Injection site erythema
|
0.00%
0/97
|
3.0%
3/100 • Number of events 3
|
3.0%
3/99 • Number of events 5
|
5.1%
5/98 • Number of events 5
|
|
General disorders
Fatigue
|
1.0%
1/97 • Number of events 1
|
3.0%
3/100 • Number of events 4
|
3.0%
3/99 • Number of events 26
|
5.1%
5/98 • Number of events 7
|
|
General disorders
Injection/vessel puncture site hematoma (1% each)
|
1.0%
1/97 • Number of events 1
|
5.0%
5/100 • Number of events 5
|
8.1%
8/99 • Number of events 9
|
4.1%
4/98 • Number of events 5
|
|
Infections and infestations
Upper respiratory tract infection
|
4.1%
4/97 • Number of events 4
|
9.0%
9/100 • Number of events 10
|
5.1%
5/99 • Number of events 5
|
4.1%
4/98 • Number of events 4
|
|
Infections and infestations
Urinary tract infection
|
1.0%
1/97 • Number of events 1
|
7.0%
7/100 • Number of events 7
|
8.1%
8/99 • Number of events 8
|
0.00%
0/98
|
|
Infections and infestations
Nasopharyngitis
|
1.0%
1/97 • Number of events 1
|
4.0%
4/100 • Number of events 4
|
2.0%
2/99 • Number of events 2
|
2.0%
2/98 • Number of events 2
|
|
Nervous system disorders
Headache
|
3.1%
3/97 • Number of events 3
|
9.0%
9/100 • Number of events 10
|
10.1%
10/99 • Number of events 14
|
15.3%
15/98 • Number of events 18
|
|
Nervous system disorders
Dizziness
|
1.0%
1/97 • Number of events 1
|
2.0%
2/100 • Number of events 2
|
4.0%
4/99 • Number of events 7
|
7.1%
7/98 • Number of events 23
|
|
Nervous system disorders
Paresthesia
|
1.0%
1/97 • Number of events 2
|
2.0%
2/100 • Number of events 3
|
3.0%
3/99 • Number of events 3
|
2.0%
2/98 • Number of events 3
|
|
Vascular disorders
Flushing
|
0.00%
0/97
|
17.0%
17/100 • Number of events 36
|
15.2%
15/99 • Number of events 46
|
17.3%
17/98 • Number of events 34
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.1%
2/97 • Number of events 3
|
4.0%
4/100 • Number of events 4
|
2.0%
2/99 • Number of events 2
|
3.1%
3/98 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/97
|
3.0%
3/100 • Number of events 3
|
4.0%
4/99 • Number of events 4
|
1.0%
1/98 • Number of events 2
|
|
Infections and infestations
Sinusitis
|
3.1%
3/97 • Number of events 3
|
1.0%
1/100 • Number of events 1
|
2.0%
2/99 • Number of events 2
|
2.0%
2/98 • Number of events 2
|
|
Nervous system disorders
Somnolence
|
0.00%
0/97
|
1.0%
1/100 • Number of events 1
|
3.0%
3/99 • Number of events 5
|
3.1%
3/98 • Number of events 20
|
|
Vascular disorders
Hypertension
|
2.1%
2/97 • Number of events 2
|
3.0%
3/100 • Number of events 3
|
0.00%
0/99
|
2.0%
2/98 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.1%
2/97 • Number of events 2
|
2.0%
2/100 • Number of events 2
|
2.0%
2/99 • Number of events 2
|
1.0%
1/98 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/97
|
3.0%
3/100 • Number of events 4
|
1.0%
1/99 • Number of events 1
|
3.1%
3/98 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain/discomfort, lower/upper abdominal pain, dyspepsia (1% each)
|
2.1%
2/97 • Number of events 2
|
5.0%
5/100 • Number of events 8
|
3.0%
3/99 • Number of events 4
|
4.1%
4/98 • Number of events 7
|
|
General disorders
Feeling hot/jittery, inj site reac/hemorrhage/rash, pain, chest pain (1% each)
|
6.2%
6/97 • Number of events 6
|
5.0%
5/100 • Number of events 8
|
2.0%
2/99 • Number of events 2
|
7.1%
7/98 • Number of events 12
|
|
Infections and infestations
Fungal infect, gastroenter/bronchitis, vulvo/vaginitis, follicul/pharyngitis, tooth abcess (1% each)
|
7.2%
7/97 • Number of events 8
|
7.0%
7/100 • Number of events 8
|
4.0%
4/99 • Number of events 4
|
7.1%
7/98 • Number of events 7
|
|
Nervous system disorders
Migraine, sciatica, sinus headache (1% each)
|
1.0%
1/97 • Number of events 1
|
4.0%
4/100 • Number of events 4
|
3.0%
3/99 • Number of events 3
|
3.1%
3/98 • Number of events 3
|
|
Vascular disorders
Hematoma, hot flush (1% each)
|
1.0%
1/97 • Number of events 1
|
3.0%
3/100 • Number of events 3
|
1.0%
1/99 • Number of events 3
|
3.1%
3/98 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain/myalgia, arthralgia, muscle spasms, flank pain (1% each)
|
6.2%
6/97 • Number of events 6
|
3.0%
3/100 • Number of events 4
|
3.0%
3/99 • Number of events 3
|
6.1%
6/98 • Number of events 13
|
|
Reproductive system and breast disorders
Vag hemorrh/discharge, breast tend/mass, metrorrhagia, menstru irreg, genit discomfort/order (1% ea)
|
7.2%
7/97 • Number of events 8
|
3.0%
3/100 • Number of events 3
|
4.0%
4/99 • Number of events 4
|
9.2%
9/98 • Number of events 10
|
|
Investigations
CPK/glu/lipase/chol/BP/triglycerides increased, iron decreased, MCV abnormal (1% each)
|
3.1%
3/97 • Number of events 3
|
8.0%
8/100 • Number of events 8
|
4.0%
4/99 • Number of events 4
|
5.1%
5/98 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Acne, pruritis, dermatitis contact, erythema, rash, urticaria (1% each)
|
4.1%
4/97 • Number of events 4
|
4.0%
4/100 • Number of events 5
|
5.1%
5/99 • Number of events 5
|
3.1%
3/98 • Number of events 3
|
|
Injury, poisoning and procedural complications
Contusion, fall, joint sprain, procedural dizziness/pain, thermal pain (1% each)
|
4.1%
4/97 • Number of events 4
|
1.0%
1/100 • Number of events 1
|
5.1%
5/99 • Number of events 5
|
4.1%
4/98 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Cough, nasal/sinus congestion (1% each)
|
1.0%
1/97 • Number of events 1
|
2.0%
2/100 • Number of events 2
|
4.0%
4/99 • Number of events 7
|
2.0%
2/98 • Number of events 3
|
|
Psychiatric disorders
Insomnia, libido increased, restlessness (1% each)
|
1.0%
1/97 • Number of events 1
|
1.0%
1/100 • Number of events 1
|
4.0%
4/99 • Number of events 22
|
2.0%
2/98 • Number of events 2
|
|
Immune system disorders
Hypersensitivity, seasonal allergy (1% each)
|
3.1%
3/97 • Number of events 3
|
1.0%
1/100 • Number of events 1
|
1.0%
1/99 • Number of events 1
|
0.00%
0/98
|
|
Blood and lymphatic system disorders
Anemia
|
1.0%
1/97 • Number of events 1
|
3.0%
3/100 • Number of events 3
|
0.00%
0/99
|
0.00%
0/98
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/97
|
0.00%
0/100
|
0.00%
0/99
|
2.0%
2/98 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic nevus
|
0.00%
0/97
|
1.0%
1/100 • Number of events 1
|
1.0%
1/99 • Number of events 1
|
0.00%
0/98
|
Additional Information
Jeffrey Edelson, MD, FRCPC
Palatin Technologies, Inc.
Phone: (609) 495-2200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60