Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder
Study Details
Study Description
Brief Summary
This trial is designed to evaluate the efficacy and safety of 3 fixed dose levels of bremelanotide, administered subcutaneously on an as-needed basis under conditions of home use, for the treatment of female sexual arousal disorder (FSAD), hypoactive sexual desire disorder (HSDD), or mixed FSAD/HSDD in premenopausal women.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Same formulation as the investigation product but without the active ingredient, provided as pre-filled syringes containing 0.3 mL volume. Subjects will self-administer the placebo by SC injection in the same manner as the investigational product. |
Drug: bremelanotide
Subjects will administer drug on an as needed basis, prior to anticipated sexual activity.
Investigational product: Bremelanotide aqueous solution for subcutaneous (SC) injection, provided as pre-filled syringes containing 0.75, 1.25, or 1.75 mg in 0.3 mL volume. Subjects will self-administer bremelanotide by SC injection into the anterior thigh or abdomen.
Placebo: Same formulation as the investigation product but without the active ingredient, provided as pre-filled syringes containing 0.3 mL volume. Subjects will self-administer the placebo by SC injection in the same manner as the investigational product.
Other Names:
|
| Experimental: bremelanotide arm 1 Low dose: Investigational product: Bremelanotide aqueous solution for subcutaneous (SC) injection, provided as pre-filled syringes containing 0.75 mg in 0.3 mL volume. Subjects will self-administer bremelanotide by SC injection into the anterior thigh or abdomen. |
Drug: bremelanotide
Subjects will administer drug on an as needed basis, prior to anticipated sexual activity.
Investigational product: Bremelanotide aqueous solution for subcutaneous (SC) injection, provided as pre-filled syringes containing 0.75, 1.25, or 1.75 mg in 0.3 mL volume. Subjects will self-administer bremelanotide by SC injection into the anterior thigh or abdomen.
Placebo: Same formulation as the investigation product but without the active ingredient, provided as pre-filled syringes containing 0.3 mL volume. Subjects will self-administer the placebo by SC injection in the same manner as the investigational product.
Other Names:
|
| Experimental: bremelanotide arm 2 Middle dose: Investigational product: Bremelanotide aqueous solution for subcutaneous (SC) injection, provided as pre-filled syringes containing 1.25 mg in 0.3 mL volume. Subjects will self-administer bremelanotide by SC injection into the anterior thigh or abdomen. |
Drug: bremelanotide
Subjects will administer drug on an as needed basis, prior to anticipated sexual activity.
Investigational product: Bremelanotide aqueous solution for subcutaneous (SC) injection, provided as pre-filled syringes containing 0.75, 1.25, or 1.75 mg in 0.3 mL volume. Subjects will self-administer bremelanotide by SC injection into the anterior thigh or abdomen.
Placebo: Same formulation as the investigation product but without the active ingredient, provided as pre-filled syringes containing 0.3 mL volume. Subjects will self-administer the placebo by SC injection in the same manner as the investigational product.
Other Names:
|
| Experimental: bremelanotide arm 3 High dose: Investigational product: Bremelanotide aqueous solution for subcutaneous (SC) injection, provided as pre-filled syringes containing 1.75 mg in 0.3 mL volume. Subjects will self-administer bremelanotide by SC injection into the anterior thigh or abdomen. |
Drug: bremelanotide
Subjects will administer drug on an as needed basis, prior to anticipated sexual activity.
Investigational product: Bremelanotide aqueous solution for subcutaneous (SC) injection, provided as pre-filled syringes containing 0.75, 1.25, or 1.75 mg in 0.3 mL volume. Subjects will self-administer bremelanotide by SC injection into the anterior thigh or abdomen.
Placebo: Same formulation as the investigation product but without the active ingredient, provided as pre-filled syringes containing 0.3 mL volume. Subjects will self-administer the placebo by SC injection in the same manner as the investigational product.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- The Primary Efficacy Endpoint is Change From Baseline to End of Study in the Number of Satisfying Sexual Events (SSE) [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.
Secondary Outcome Measures
- Change From Baseline to End-of-Study in Arousal Domain Score From Female Sexual Function Index [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).
- Satisfaction With Arousal as Measured by GAQ Question 1 [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).
- Desire Domain From Female Sexual Function Index [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).
- Satisfaction With Desire as Measured by GAQ Question 2 [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).
- Quality of Relationship With Partner as Measured by GAQ Question 4 [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).
- FSDS-DAO Total Score [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
Female, at least 21 years of age, and premenopausal Previously experienced sexual arousal during sexual activity and/or normal level of desire in the past for least 2 years.
Willing to engage in sexual activities Currently in stable relationship with a partner(male or female)for at least 6 months.
If subject has a male sexual partner, has recorded a score of "not impotent" or "minimally impotent" on Single-question Assessment of ED.
For at least 6 months before Screening, has met diagnostic criteria for FSAD, HSDD, or mixed FSAD/HSDD Has a negative serum pregnancy test (hCG) at Screening and, if subject's partner is male, has used a medically acceptable form of contraception for the 3 months before Screening (Visit 1), and is willing to continue for the duration of the trial and 1 month following the last dose of trial drug.
Has a normal pelvic examination. At Screening or documented within 12 months before Screening, has:normal Pap test results with or without history of positive HPV, dysplasia, or ASCUS that has resolved or been treated;Pap test results positive for ASCUS and negative for HPV;Pap test results positive for HPV AND no ASCUS or dysplasia on Pap or condyloma present upon examination.
At Screening and Visit 2, meets all necessary questionnaire scores.
Exclusion Criteria:
Medical condition that is unstable or uncontrolled despite current therapy. History of unresolved sexual trauma or abuse. Pregnant or nursing. Lifelong anorgasmia, vaginismus, sexual pain disorder, sexual aversion disorder, or persistent sexual arousal disorder.
Female sexual dysfunction caused by untreated endocrine disease. Has or has had any of the following: hepatitis C, other infectious hepatitis, infectious blood disorders such as HIV; myocardial infarction;stroke.
Has or has had any of the following within 12 months before Screening:chronic dyspareunia not attributable to vaginal dryness; pelvic inflammatory disease; chronic or complicated UTI, or an active STD other than herpes and condyloma; cervical dysplasia, including LGSIL and HGSIL and/or ASCUS with HPV; significant cervicitis as manifested by mucopurulent discharge from the cervix.
Has had any of the following within 6 months before Screening:≥ 2 outbreaks of genital herpes; occurrence/recurrence of clinically significant condyloma;clinically unstable angina or clinically unstable arrhythmia;significant CNS diseases;AST or ALT concentrations
3 times the ULN;serum creatinine > 2.5 mg/dL;any other clinically significant abnormal laboratory result.
Has used prohibited medications within the 3 months before Screening:
Has currently active moderate to severe vaginitis or a clinically significant vaginal infection.
Has one or more significant gynecologic conditions . Is taking or has received treatment for psychosis, bipolar disorder, depression, and/or alcohol/substance abuse within 6 months before Screening.
Is currently receiving psychotherapy for the treatment of FSAD and/or HSDD. Has any of the following: Uncontrolled hypertension;Systolic BP of ≥ 140 mm Hg at Screening;Diastolic BP of ≥ 90 mm Hg at Screening; Treatment for hypertension that has changed in the 3 months before Screening.
Had a hysterectomy with bilateral oophorectomy. Had a hysterectomy without bilateral oophorectomy AND meets several other criteria.
Is taking contraceptives that have affected the menstrual cycle or caused amenorrhea AND did not have a normal menstrual cycle before starting the contraceptive medication.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Site 56 | Birmingham | Alabama | United States | 35209 |
| 2 | Site 26 | Huntsville | Alabama | United States | 35801 |
| 3 | Site 64 | Mobile | Alabama | United States | 36608 |
| 4 | Site 45 | Chandler | Arizona | United States | 85224 |
| 5 | Site 39 | Phoenix | Arizona | United States | 85032 |
| 6 | Site 25 | Tucson | Arizona | United States | 85712 |
| 7 | Site 78 | Hot Springs | Arkansas | United States | 71901 |
| 8 | Site 16 | Jonesboro | Arkansas | United States | 72401 |
| 9 | Site 52 | National City | California | United States | 91950 |
| 10 | Site 73 | Newport Beach | California | United States | 92880 |
| 11 | Site 80 | Sacramento | California | United States | 95821 |
| 12 | Site 12 | San Diego | California | United States | 92120 |
| 13 | Site 37 | Denver | Colorado | United States | 80218 |
| 14 | Site 40 | Lakewood | Colorado | United States | 80228 |
| 15 | Site 8 | Avon | Connecticut | United States | 06117 |
| 16 | Site 75 | Farmington | Connecticut | United States | 06032 |
| 17 | Site 33 | New London | Connecticut | United States | 06320 |
| 18 | Site 32 | Washington | District of Columbia | United States | 20036 |
| 19 | Site 10 | Aventura | Florida | United States | 33180 |
| 20 | Site 27 | Fort Myers | Florida | United States | 33916 |
| 21 | Site 66 | Melbourne | Florida | United States | 32935 |
| 22 | Site 61 | Orlando | Florida | United States | 32806 |
| 23 | Site 1 | West Palm Beach | Florida | United States | 33401 |
| 24 | Site 82 | Atlanta | Georgia | United States | 30328 |
| 25 | Site 55 | Decatur | Georgia | United States | 30030 |
| 26 | Site 70 | Chicago | Illinois | United States | 60654 |
| 27 | Site 54 | Peoria | Illinois | United States | 61602 |
| 28 | Site 63 | South Bend | Indiana | United States | 46545 |
| 29 | Site 13 | Wichita | Kansas | United States | 67226 |
| 30 | Site 48 | Lexington | Kentucky | United States | 40509 |
| 31 | Site 57 | Zachary | Louisiana | United States | 70791 |
| 32 | Site 9 | Baltimore | Maryland | United States | 21093 |
| 33 | Site 60 | Rockville | Maryland | United States | 20850 |
| 34 | Site 74 | St. Louis | Missouri | United States | 63141 |
| 35 | Site 35 | Lincoln | Nebraska | United States | 68510 |
| 36 | Site 72 | Las Vegas | Nevada | United States | 89113 |
| 37 | Site 24 | Las Vegas | Nevada | United States | 89128 |
| 38 | Site 18 | New York | New York | United States | 10016 |
| 39 | Site 38 | Purchase | New York | United States | 10577 |
| 40 | Site 3 | Raleigh | North Carolina | United States | 27612 |
| 41 | Site 47 | Winston-Salem | North Carolina | United States | 27103 |
| 42 | Site 23 | Beachwood | Ohio | United States | 44122 |
| 43 | Site 69 | Canton | Ohio | United States | 44718 |
| 44 | Site 71 | Cincinnati | Ohio | United States | 45249 |
| 45 | Site 19 | Cleveland | Ohio | United States | 44124 |
| 46 | Site 30 | Columbus | Ohio | United States | 43213 |
| 47 | Site 81 | Englewood | Ohio | United States | 45322 |
| 48 | Site 2 | Eugene | Oregon | United States | 97401 |
| 49 | Site 42 | Philadelphia | Pennsylvania | United States | 19107 |
| 50 | Site 77 | Pittsburgh | Pennsylvania | United States | 15206 |
| 51 | Site 43 | Warwick | Rhode Island | United States | 02886 |
| 52 | Site 58 | Greer | South Carolina | United States | 29650 |
| 53 | Site 49 | Mt. Pleasant | South Carolina | United States | 29464 |
| 54 | Site 53 | Chattanooga | Tennessee | United States | 37404 |
| 55 | Site 59 | Corpus Christi | Texas | United States | 78414 |
| 56 | Site 76 | Dallas | Texas | United States | 75231 |
| 57 | Site 31 | Dallas | Texas | United States | 75234 |
| 58 | Site 17 | Houston | Texas | United States | 77054 |
| 59 | Site 62 | San Antonio | Texas | United States | 78229 |
| 60 | Site 50 | Murray | Utah | United States | 84123 |
| 61 | Site 36 | Sandy | Utah | United States | 84070 |
| 62 | Site 7 | Charlottesville | Virginia | United States | 22903 |
| 63 | Site 68 | Norfolk | Virginia | United States | 23502 |
| 64 | Site 65 | Richmond | Virginia | United States | 23294 |
| 65 | Site 22 | Seattle | Washington | United States | 98105 |
| 66 | Site 4 | North Vancouver | British Columbia | Canada | V7N 2H5 |
| 67 | Site 41 | Barrie | Ontario | Canada | L4M 7G1 |
| 68 | Site 21 | Burlington | Ontario | Canada | L7R4G1 |
Sponsors and Collaborators
- Palatin Technologies, Inc
Investigators
- Study Director: Jeffrey Edelson, MD, FRCPC, Palatin Technologies, Inc
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PT-141-54
Study Results
Participant Flow
| Recruitment Details | 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. |
|---|---|
| Pre-assignment Detail | 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). |
| Arm/Group Title | Placebo | Bremelanotide Arm 1 | Bremelanotide Arm 2 | Bremelanotide Arm 3 |
|---|---|---|---|---|
| Arm/Group Description | identical formulation without active ingredient | low dose 0.75 mg BMT | middle dose 1.25 mg BMT | high dose 1.75 mg BMT |
| Period Title: Overall Study | ||||
| STARTED | 98 | 100 | 100 | 99 |
| Subjects Not Dosed | 1 | 0 | 1 | 1 |
| COMPLETED | 80 | 81 | 66 | 66 |
| NOT COMPLETED | 18 | 19 | 34 | 33 |
Baseline Characteristics
| Arm/Group Title | Placebo | Bremelanotide Arm 1 | Bremelanotide Arm 2 | Bremelanotide Arm 3 | Total |
|---|---|---|---|---|---|
| Arm/Group Description | identical formulation without active ingredient | low dose 0.75 mg BMT | middle dose 1.25 mg BMT | high dose 1.75 mg BMT | Total of all reporting groups |
| Overall Participants | 97 | 100 | 99 | 98 | 394 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
37.0
(7.70)
|
37.6
(7.76)
|
35.7
(7.22)
|
37.0
(7.56)
|
36.9
(7.57)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
97
100%
|
100
100%
|
99
100%
|
98
100%
|
394
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race/Ethnicity, Customized (Number) [Number] | |||||
| American Indian or Alaska Native |
2
2.1%
|
1
1%
|
1
1%
|
1
1%
|
5
1.3%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
2
2%
|
2
0.5%
|
| Native Hawaiian or Other Pacific Islander |
1
1%
|
0
0%
|
0
0%
|
0
0%
|
1
0.3%
|
| Black or African American |
19
19.6%
|
25
25%
|
32
32.3%
|
23
23.5%
|
99
25.1%
|
| White |
75
77.3%
|
71
71%
|
65
65.7%
|
70
71.4%
|
281
71.3%
|
| Other |
0
0%
|
3
3%
|
0
0%
|
2
2%
|
5
1.3%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
1
1%
|
0
0%
|
1
0.3%
|
| Weight (Pound) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [Pound] |
164.40
(42.050)
|
168.17
(37.867)
|
173.97
(43.229)
|
179.15
(45.872)
|
171.41
(42.532)
|
| Body Mass Index (kg/m2) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [kg/m2] |
27.73
(6.171)
|
28.47
(6.616)
|
29.17
(7.096)
|
29.92
(7.181)
|
28.82
(6.802)
|
| Of Childbearing Potential (Number) [Number] | |||||
| Of Childbearing Potential |
72
74.2%
|
76
76%
|
70
70.7%
|
65
66.3%
|
283
71.8%
|
| Surgically Sterile |
25
25.8%
|
24
24%
|
29
29.3%
|
32
32.7%
|
110
27.9%
|
| Data Missing |
0
0%
|
0
0%
|
0
0%
|
1
1%
|
1
0.3%
|
| Weight Quartile (Pound) [Number] | |||||
| 95 - 143 pounds |
37
|
21
|
23
|
21
|
102
|
| >143 - 165 pounds |
18
|
36
|
25
|
24
|
103
|
| >165 - 200.6 pounds |
23
|
26
|
28
|
24
|
101
|
| >200.6 - 350 pounds |
19
|
17
|
23
|
28
|
87
|
| Data Missing |
0
|
0
|
0
|
1
|
1
|
| Menses Frequency (Number) [Number] | |||||
| Variable cycle length (<7 days different from nor |
3
3.1%
|
4
4%
|
4
4%
|
4
4.1%
|
15
3.8%
|
| Regular |
72
74.2%
|
75
75%
|
86
86.9%
|
79
80.6%
|
312
79.2%
|
| Variable cycle length (>7 days different from nor |
7
7.2%
|
2
2%
|
1
1%
|
2
2%
|
12
3%
|
| 2 or more skipped cycles, and amenorrhea for 60 or |
2
2.1%
|
6
6%
|
2
2%
|
1
1%
|
11
2.8%
|
| N.A. |
13
13.4%
|
13
13%
|
6
6.1%
|
12
12.2%
|
44
11.2%
|
| Natural Hair Color (Number) [Number] | |||||
| Red |
6
6.2%
|
5
5%
|
6
6.1%
|
6
6.1%
|
23
5.8%
|
| Other Than Red |
91
93.8%
|
95
95%
|
93
93.9%
|
92
93.9%
|
371
94.2%
|
| Diagnosis (Number) [Number] | |||||
| FSAD |
4
4.1%
|
3
3%
|
3
3%
|
2
2%
|
12
3%
|
| HSDD |
24
24.7%
|
20
20%
|
24
24.2%
|
24
24.5%
|
92
23.4%
|
| Mixed FSAD/HSDD |
69
71.1%
|
77
77%
|
72
72.7%
|
72
73.5%
|
290
73.6%
|
| Oral Contraceptive Use within 30 Days of Visit 1 (Number) [Number] | |||||
| Yes |
12
12.4%
|
15
15%
|
11
11.1%
|
15
15.3%
|
53
13.5%
|
| No |
85
87.6%
|
85
85%
|
88
88.9%
|
83
84.7%
|
341
86.5%
|
Outcome Measures
| Title | The Primary Efficacy Endpoint is Change From Baseline to End of Study in the Number of Satisfying Sexual Events (SSE) |
|---|---|
| Description | 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. |
| Time Frame | 4 - 12 weeks from baseline to end of study (total study duration 20 weeks). Baseline was the 4-week single-blind placebo period. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Placebo | Bremelanotide Arm 1 | Bremelanotide Arm 2 | Bremelanotide Arm 3 |
|---|---|---|---|---|
| Arm/Group Description | identical formulation without active ingredient | low dose 0.75 mg BMT | middle dose 1.25 mg BMT | high dose 1.75 mg BMT |
| Measure Participants | 91 | 87 | 75 | 74 |
| Mean (Standard Deviation) [SSEs] |
0.2
(2.29)
|
0.6
(3.55)
|
0.7
(1.81)
|
0.8
(2.86)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Bremelanotide Arm 3 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | ||
| Method | Van Elteren | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.0215 | |
| Confidence Interval |
(2-Sided) 95% 0.0 to 1.0 |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 2.9 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Bremelanotide Arm 1, Bremelanotide Arm 2, Bremelanotide Arm 3 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | ||
| Method | Van Elteren | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.0012 | |
| Confidence Interval |
(2-Sided) 95% 0.00 to 0.06 |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 0.0012 |
|
| Estimation Comments | ||
| Title | Change From Baseline to End-of-Study in Arousal Domain Score From Female Sexual Function Index |
|---|---|
| Description | 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). |
| Time Frame | 4-12 weeks from baseline to end of study (total study duration 20 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Placebo | Bremelanotide Arm 1 | Bremelanotide Arm 2 | Bremelanotide Arm 3 |
|---|---|---|---|---|
| Arm/Group Description | identical formulation without active ingredient | low dose 0.75 mg BMT | middle dose 1.25 mg BMT | high dose 1.75 mg BMT |
| Measure Participants | 91 | 87 | 75 | 74 |
| Mean (Standard Deviation) [units on a scale] |
0.51
(1.371)
|
0.35
(1.457)
|
0.71
(1.112)
|
1.06
(1.146)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Bremelanotide Arm 1, Bremelanotide Arm 2, Bremelanotide Arm 3 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.0496 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Satisfaction With Arousal as Measured by GAQ Question 1 |
|---|---|
| Description | 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). |
| Time Frame | 4-12 weeks from baseline to end of study (total study duration 20 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Placebo | Bremelanotide Arm 1 | Bremelanotide Arm 2 | Bremelanotide Arm 3 |
|---|---|---|---|---|
| Arm/Group Description | identical formulation without active ingredient | low dose 0.75 mg BMT | middle dose 1.25 mg BMT | high dose 1.75 mg BMT |
| Measure Participants | 91 | 87 | 75 | 74 |
| Mean (Standard Deviation) [units on a scale] |
0.4
(1.37)
|
0.3
(1.43)
|
0.5
(1.46)
|
0.9
(1.18)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Bremelanotide Arm 3 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | ||
| Method | Van Elteren | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.0079 | |
| Confidence Interval |
(2-Sided) 95% 0.00 to 1.00 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Desire Domain From Female Sexual Function Index |
|---|---|
| Description | 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). |
| Time Frame | 4-12 weeks from baseline to end of study (total study duration 20 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Placebo | Bremelanotide Arm 1 | Bremelanotide Arm 2 | Bremelanotide Arm 3 |
|---|---|---|---|---|
| Arm/Group Description | identical formulation without active ingredient | low dose 0.75 mg BMT | middle dose 1.25 mg BMT | high dose 1.75 mg BMT |
| Measure Participants | 91 | 87 | 75 | 74 |
| Mean (Standard Deviation) [units on a scale] |
0.39
(1.075)
|
0.33
(1.093)
|
0.55
(0.794)
|
0.95
(1.003)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Bremelanotide Arm 3 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | ||
| Method | Van Elteren | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.0012 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Satisfaction With Desire as Measured by GAQ Question 2 |
|---|---|
| Description | 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). |
| Time Frame | 4-12 weeks from baseline to end of study (total study duration 20 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Placebo | Bremelanotide Arm 1 | Bremelanotide Arm 2 | Bremelanotide Arm 3 |
|---|---|---|---|---|
| Arm/Group Description | identical formulation without active ingredient | low dose 0.75 mg BMT | middle dose 1.25 mg BMT | high dose 1.75 mg BMT |
| Measure Participants | 91 | 87 | 75 | 74 |
| Mean (Standard Deviation) [units on a scale] |
0.4
(1.31)
|
0.3
(1.32)
|
0.8
(1.44)
|
0.9
(1.20)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Bremelanotide Arm 3 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | ||
| Method | Van Elteren | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.0013 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Quality of Relationship With Partner as Measured by GAQ Question 4 |
|---|---|
| Description | 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). |
| Time Frame | 4-12 weeks from baseline to end of study (total study duration 20 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Placebo | Bremelanotide Arm 1 | Bremelanotide Arm 2 | Bremelanotide Arm 3 |
|---|---|---|---|---|
| Arm/Group Description | identical formulation without active ingredient | low dose 0.75 mg BMT | middle dose 1.25 mg BMT | high dose 1.75 mg BMT |
| Measure Participants | 91 | 87 | 75 | 74 |
| Mean (Standard Deviation) [units on a scale] |
0.3
(1.20)
|
0.3
(1.24)
|
0.4
(1.22)
|
0.6
(1.22)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Bremelanotide Arm 3 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | ||
| Method | Van Elteren | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.1161 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | FSDS-DAO Total Score |
|---|---|
| Description | 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. |
| Time Frame | 4 - 12 weeks from baseline to end of study (total study duration 20 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Placebo | Bremelanotide Arm 1 | Bremelanotide Arm 2 | Bremelanotide Arm 3 |
|---|---|---|---|---|
| Arm/Group Description | identical formulation without active ingredient | low dose 0.75 mg BMT | middle dose 1.25 mg BMT | high dose 1.75 mg BMT |
| Measure Participants | 91 | 87 | 75 | 74 |
| Mean (Standard Deviation) [units on a scale] |
-6.8
(13.57)
|
-7.4
(13.47)
|
-9.2
(10.79)
|
-13.1
(12.93)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Bremelanotide Arm 3 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.0133 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | ||||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | Placebo | Bremelanotide Arm 1 | Bremelanotide Arm 2 | Bremelanotide Arm 3 | ||||
| Arm/Group Description | identical formulation without active ingredient | low dose 0.75 mg BMT | middle dose 1.25 mg BMT | high dose 1.75 mg BMT | ||||
All Cause Mortality |
||||||||
| Placebo | Bremelanotide Arm 1 | Bremelanotide Arm 2 | Bremelanotide Arm 3 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Placebo | Bremelanotide Arm 1 | Bremelanotide Arm 2 | Bremelanotide Arm 3 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/97 (3.1%) | 1/100 (1%) | 1/99 (1%) | 1/98 (1%) | ||||
| Cardiac disorders | ||||||||
| Chest pain | 0/97 (0%) | 0 | 0/100 (0%) | 0 | 0/99 (0%) | 0 | 1/98 (1%) | 1 |
| Infections and infestations | ||||||||
| Escherichia bacteremia | 1/97 (1%) | 1 | 0/100 (0%) | 0 | 0/99 (0%) | 0 | 0/98 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Intervertebral disc protrusion | 1/97 (1%) | 1 | 0/100 (0%) | 0 | 0/99 (0%) | 0 | 0/98 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||
| Menometrorrhagia | 1/97 (1%) | 1 | 0/100 (0%) | 0 | 0/99 (0%) | 0 | 0/98 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Asthma | 0/97 (0%) | 0 | 1/100 (1%) | 1 | 0/99 (0%) | 0 | 0/98 (0%) | 0 |
| Surgical and medical procedures | ||||||||
| Incisional hernia | 0/97 (0%) | 0 | 0/100 (0%) | 0 | 1/99 (1%) | 1 | 0/98 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||
| Placebo | Bremelanotide Arm 1 | Bremelanotide Arm 2 | Bremelanotide Arm 3 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 49/97 (50.5%) | 64/100 (64%) | 61/99 (61.6%) | 67/98 (68.4%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anemia | 1/97 (1%) | 1 | 3/100 (3%) | 3 | 0/99 (0%) | 0 | 0/98 (0%) | 0 |
| Cardiac disorders | ||||||||
| Sinus bradycardia | 0/97 (0%) | 0 | 0/100 (0%) | 0 | 0/99 (0%) | 0 | 2/98 (2%) | 2 |
| Gastrointestinal disorders | ||||||||
| Nausea | 3/97 (3.1%) | 3 | 18/100 (18%) | 34 | 22/99 (22.2%) | 63 | 24/98 (24.5%) | 51 |
| Vomiting | 0/97 (0%) | 0 | 2/100 (2%) | 2 | 4/99 (4%) | 6 | 6/98 (6.1%) | 11 |
| Diarrhea | 0/97 (0%) | 0 | 3/100 (3%) | 4 | 1/99 (1%) | 1 | 3/98 (3.1%) | 3 |
| Abdominal pain/discomfort, lower/upper abdominal pain, dyspepsia (1% each) | 2/97 (2.1%) | 2 | 5/100 (5%) | 8 | 3/99 (3%) | 4 | 4/98 (4.1%) | 7 |
| General disorders | ||||||||
| Injection site pain | 3/97 (3.1%) | 6 | 6/100 (6%) | 8 | 6/99 (6.1%) | 10 | 7/98 (7.1%) | 9 |
| Injection site pruritus | 0/97 (0%) | 0 | 4/100 (4%) | 6 | 4/99 (4%) | 7 | 6/98 (6.1%) | 7 |
| Injection site erythema | 0/97 (0%) | 0 | 3/100 (3%) | 3 | 3/99 (3%) | 5 | 5/98 (5.1%) | 5 |
| Fatigue | 1/97 (1%) | 1 | 3/100 (3%) | 4 | 3/99 (3%) | 26 | 5/98 (5.1%) | 7 |
| Injection/vessel puncture site hematoma (1% each) | 1/97 (1%) | 1 | 5/100 (5%) | 5 | 8/99 (8.1%) | 9 | 4/98 (4.1%) | 5 |
| Feeling hot/jittery, inj site reac/hemorrhage/rash, pain, chest pain (1% each) | 6/97 (6.2%) | 6 | 5/100 (5%) | 8 | 2/99 (2%) | 2 | 7/98 (7.1%) | 12 |
| Immune system disorders | ||||||||
| Hypersensitivity, seasonal allergy (1% each) | 3/97 (3.1%) | 3 | 1/100 (1%) | 1 | 1/99 (1%) | 1 | 0/98 (0%) | 0 |
| Infections and infestations | ||||||||
| Upper respiratory tract infection | 4/97 (4.1%) | 4 | 9/100 (9%) | 10 | 5/99 (5.1%) | 5 | 4/98 (4.1%) | 4 |
| Urinary tract infection | 1/97 (1%) | 1 | 7/100 (7%) | 7 | 8/99 (8.1%) | 8 | 0/98 (0%) | 0 |
| Nasopharyngitis | 1/97 (1%) | 1 | 4/100 (4%) | 4 | 2/99 (2%) | 2 | 2/98 (2%) | 2 |
| Sinusitis | 3/97 (3.1%) | 3 | 1/100 (1%) | 1 | 2/99 (2%) | 2 | 2/98 (2%) | 2 |
| Fungal infect, gastroenter/bronchitis, vulvo/vaginitis, follicul/pharyngitis, tooth abcess (1% each) | 7/97 (7.2%) | 8 | 7/100 (7%) | 8 | 4/99 (4%) | 4 | 7/98 (7.1%) | 7 |
| Injury, poisoning and procedural complications | ||||||||
| Contusion, fall, joint sprain, procedural dizziness/pain, thermal pain (1% each) | 4/97 (4.1%) | 4 | 1/100 (1%) | 1 | 5/99 (5.1%) | 5 | 4/98 (4.1%) | 4 |
| Investigations | ||||||||
| CPK/glu/lipase/chol/BP/triglycerides increased, iron decreased, MCV abnormal (1% each) | 3/97 (3.1%) | 3 | 8/100 (8%) | 8 | 4/99 (4%) | 4 | 5/98 (5.1%) | 5 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Back pain | 2/97 (2.1%) | 3 | 4/100 (4%) | 4 | 2/99 (2%) | 2 | 3/98 (3.1%) | 3 |
| Pain in extremity | 0/97 (0%) | 0 | 3/100 (3%) | 3 | 4/99 (4%) | 4 | 1/98 (1%) | 2 |
| Musculoskeletal pain/myalgia, arthralgia, muscle spasms, flank pain (1% each) | 6/97 (6.2%) | 6 | 3/100 (3%) | 4 | 3/99 (3%) | 3 | 6/98 (6.1%) | 13 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Melanocytic nevus | 0/97 (0%) | 0 | 1/100 (1%) | 1 | 1/99 (1%) | 1 | 0/98 (0%) | 0 |
| Nervous system disorders | ||||||||
| Headache | 3/97 (3.1%) | 3 | 9/100 (9%) | 10 | 10/99 (10.1%) | 14 | 15/98 (15.3%) | 18 |
| Dizziness | 1/97 (1%) | 1 | 2/100 (2%) | 2 | 4/99 (4%) | 7 | 7/98 (7.1%) | 23 |
| Paresthesia | 1/97 (1%) | 2 | 2/100 (2%) | 3 | 3/99 (3%) | 3 | 2/98 (2%) | 3 |
| Somnolence | 0/97 (0%) | 0 | 1/100 (1%) | 1 | 3/99 (3%) | 5 | 3/98 (3.1%) | 20 |
| Migraine, sciatica, sinus headache (1% each) | 1/97 (1%) | 1 | 4/100 (4%) | 4 | 3/99 (3%) | 3 | 3/98 (3.1%) | 3 |
| Psychiatric disorders | ||||||||
| Insomnia, libido increased, restlessness (1% each) | 1/97 (1%) | 1 | 1/100 (1%) | 1 | 4/99 (4%) | 22 | 2/98 (2%) | 2 |
| Reproductive system and breast disorders | ||||||||
| Vag hemorrh/discharge, breast tend/mass, metrorrhagia, menstru irreg, genit discomfort/order (1% ea) | 7/97 (7.2%) | 8 | 3/100 (3%) | 3 | 4/99 (4%) | 4 | 9/98 (9.2%) | 10 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Oropharyngeal pain | 2/97 (2.1%) | 2 | 2/100 (2%) | 2 | 2/99 (2%) | 2 | 1/98 (1%) | 1 |
| Cough, nasal/sinus congestion (1% each) | 1/97 (1%) | 1 | 2/100 (2%) | 2 | 4/99 (4%) | 7 | 2/98 (2%) | 3 |
| Skin and subcutaneous tissue disorders | ||||||||
| Acne, pruritis, dermatitis contact, erythema, rash, urticaria (1% each) | 4/97 (4.1%) | 4 | 4/100 (4%) | 5 | 5/99 (5.1%) | 5 | 3/98 (3.1%) | 3 |
| Vascular disorders | ||||||||
| Flushing | 0/97 (0%) | 0 | 17/100 (17%) | 36 | 15/99 (15.2%) | 46 | 17/98 (17.3%) | 34 |
| Hypertension | 2/97 (2.1%) | 2 | 3/100 (3%) | 3 | 0/99 (0%) | 0 | 2/98 (2%) | 2 |
| Hematoma, hot flush (1% each) | 1/97 (1%) | 1 | 3/100 (3%) | 3 | 1/99 (1%) | 3 | 3/98 (3.1%) | 3 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Jeffrey Edelson, MD, FRCPC |
|---|---|
| Organization | Palatin Technologies, Inc. |
| Phone | (609) 495-2200 |
| jedelson@palatin.com |
- PT-141-54