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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 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. |
|
| bremelanotide arm 1 | Experimental | 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. |
|
| bremelanotide arm 2 | Experimental | 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. |
|
| bremelanotide arm 3 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bremelanotide | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Efficacy Endpoint is Change From Baseline to End of Study in the Number of Satisfying Sexual Events (SSE) | 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. | 4 - 12 weeks from baseline to end of study (total study duration 20 weeks). Baseline was the 4-week single-blind placebo period. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to End-of-Study in Arousal Domain Score From Female Sexual Function Index | 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). |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Edelson, MD, FRCPC | Palatin Technologies, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 56 | Birmingham | Alabama | 35209 | United States | ||
| Site 26 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34559353 | Derived | Derogatis LR, Revicki DA, Rosen RC, Jordan R, Lucas J, Spana C. Psychometric validation of the Female Sexual Distress Scale-Desire/Arousal/Orgasm. J Patient Rep Outcomes. 2021 Sep 24;5(1):100. doi: 10.1186/s41687-021-00359-1. | |
| 27181790 | Derived | Clayton AH, Althof SE, Kingsberg S, DeRogatis LR, Kroll R, Goldstein I, Kaminetsky J, Spana C, Lucas J, Jordan R, Portman DJ. Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial. Womens Health (Lond). 2016 Jun;12(3):325-37. doi: 10.2217/whe-2016-0018. Epub 2016 May 16. |
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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).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | identical formulation without active ingredient |
| FG001 | Bremelanotide Arm 1 | low dose 0.75 mg BMT |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
|
| 4-12 weeks from baseline to end of study (total study duration 20 weeks) |
| Satisfaction With Arousal as Measured by GAQ Question 1 | 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). | 4-12 weeks from baseline to end of study (total study duration 20 weeks) |
| Desire Domain From Female Sexual Function Index | 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). | 4-12 weeks from baseline to end of study (total study duration 20 weeks) |
| Satisfaction With Desire as Measured by GAQ Question 2 | 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). | 4-12 weeks from baseline to end of study (total study duration 20 weeks) |
| Quality of Relationship With Partner as Measured by GAQ Question 4 | 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). | 4-12 weeks from baseline to end of study (total study duration 20 weeks) |
| FSDS-DAO Total Score | 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. | 4 - 12 weeks from baseline to end of study (total study duration 20 weeks) |
| Huntsville |
| Alabama |
| 35801 |
| United States |
| Site 64 | Mobile | Alabama | 36608 | United States |
| Site 45 | Chandler | Arizona | 85224 | United States |
| Site 39 | Phoenix | Arizona | 85032 | United States |
| Site 25 | Tucson | Arizona | 85712 | United States |
| Site 78 | Hot Springs | Arkansas | 71901 | United States |
| Site 16 | Jonesboro | Arkansas | 72401 | United States |
| Site 52 | National City | California | 91950 | United States |
| Site 73 | Newport Beach | California | 92880 | United States |
| Site 80 | Sacramento | California | 95821 | United States |
| Site 12 | San Diego | California | 92120 | United States |
| Site 37 | Denver | Colorado | 80218 | United States |
| Site 40 | Lakewood | Colorado | 80228 | United States |
| Site 8 | Avon | Connecticut | 06117 | United States |
| Site 75 | Farmington | Connecticut | 06032 | United States |
| Site 33 | New London | Connecticut | 06320 | United States |
| Site 32 | Washington D.C. | District of Columbia | 20036 | United States |
| Site 10 | Aventura | Florida | 33180 | United States |
| Site 27 | Fort Myers | Florida | 33916 | United States |
| Site 66 | Melbourne | Florida | 32935 | United States |
| Site 61 | Orlando | Florida | 32806 | United States |
| Site 1 | West Palm Beach | Florida | 33401 | United States |
| Site 82 | Atlanta | Georgia | 30328 | United States |
| Site 55 | Decatur | Georgia | 30030 | United States |
| Site 70 | Chicago | Illinois | 60654 | United States |
| Site 54 | Peoria | Illinois | 61602 | United States |
| Site 63 | South Bend | Indiana | 46545 | United States |
| Site 13 | Wichita | Kansas | 67226 | United States |
| Site 48 | Lexington | Kentucky | 40509 | United States |
| Site 57 | Zachary | Louisiana | 70791 | United States |
| Site 9 | Baltimore | Maryland | 21093 | United States |
| Site 60 | Rockville | Maryland | 20850 | United States |
| Site 74 | St Louis | Missouri | 63141 | United States |
| Site 35 | Lincoln | Nebraska | 68510 | United States |
| Site 72 | Las Vegas | Nevada | 89113 | United States |
| Site 24 | Las Vegas | Nevada | 89128 | United States |
| Site 18 | New York | New York | 10016 | United States |
| Site 38 | Purchase | New York | 10577 | United States |
| Site 3 | Raleigh | North Carolina | 27612 | United States |
| Site 47 | Winston-Salem | North Carolina | 27103 | United States |
| Site 23 | Beachwood | Ohio | 44122 | United States |
| Site 69 | Canton | Ohio | 44718 | United States |
| Site 71 | Cincinnati | Ohio | 45249 | United States |
| Site 19 | Cleveland | Ohio | 44124 | United States |
| Site 30 | Columbus | Ohio | 43213 | United States |
| Site 81 | Englewood | Ohio | 45322 | United States |
| Site 2 | Eugene | Oregon | 97401 | United States |
| Site 42 | Philadelphia | Pennsylvania | 19107 | United States |
| Site 77 | Pittsburgh | Pennsylvania | 15206 | United States |
| Site 43 | Warwick | Rhode Island | 02886 | United States |
| Site 58 | Greer | South Carolina | 29650 | United States |
| Site 49 | Mt. Pleasant | South Carolina | 29464 | United States |
| Site 53 | Chattanooga | Tennessee | 37404 | United States |
| Site 59 | Corpus Christi | Texas | 78414 | United States |
| Site 76 | Dallas | Texas | 75231 | United States |
| Site 31 | Dallas | Texas | 75234 | United States |
| Site 17 | Houston | Texas | 77054 | United States |
| Site 62 | San Antonio | Texas | 78229 | United States |
| Site 50 | Murray | Utah | 84123 | United States |
| Site 36 | Sandy City | Utah | 84070 | United States |
| Site 7 | Charlottesville | Virginia | 22903 | United States |
| Site 68 | Norfolk | Virginia | 23502 | United States |
| Site 65 | Richmond | Virginia | 23294 | United States |
| Site 22 | Seattle | Washington | 98105 | United States |
| Site 4 | North Vancouver | British Columbia | V7N 2H5 | Canada |
| Site 41 | Barrie | Ontario | L4M 7G1 | Canada |
| Site 21 | Burlington | Ontario | L7R4G1 | Canada |
| FG002 |
| Bremelanotide Arm 2 |
middle dose 1.25 mg BMT |
| FG003 | Bremelanotide Arm 3 | high dose 1.75 mg BMT |
| Subjects Not Dosed |
|
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | identical formulation without active ingredient |
| BG001 | Bremelanotide Arm 1 | low dose 0.75 mg BMT |
| BG002 | Bremelanotide Arm 2 | middle dose 1.25 mg BMT |
| BG003 | Bremelanotide Arm 3 | high dose 1.75 mg BMT |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | Pound |
| |||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
| |||||||||||||||
| Of Childbearing Potential | Number | Participants |
| ||||||||||||||||
| Weight Quartile | Number | Pound |
| ||||||||||||||||
| Menses Frequency | Number | Participants |
| ||||||||||||||||
| Natural Hair Color | Number | Participants |
| ||||||||||||||||
| Diagnosis | Number | Participants |
| ||||||||||||||||
| Oral Contraceptive Use within 30 Days of Visit 1 | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Primary Efficacy Endpoint is Change From Baseline to End of Study in the Number of Satisfying Sexual Events (SSE) | 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. | Posted | Mean | Standard Deviation | SSEs | 4 - 12 weeks from baseline to end of study (total study duration 20 weeks). Baseline was the 4-week single-blind placebo period. |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to End-of-Study in Arousal Domain Score From Female Sexual Function Index | 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). | Posted | Mean | Standard Deviation | units on a scale | 4-12 weeks from baseline to end of study (total study duration 20 weeks) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Satisfaction With Arousal as Measured by GAQ Question 1 | 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). | Posted | Mean | Standard Deviation | units on a scale | 4-12 weeks from baseline to end of study (total study duration 20 weeks) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Desire Domain From Female Sexual Function Index | 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). | Posted | Mean | Standard Deviation | units on a scale | 4-12 weeks from baseline to end of study (total study duration 20 weeks) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Satisfaction With Desire as Measured by GAQ Question 2 | 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). | Posted | Mean | Standard Deviation | units on a scale | 4-12 weeks from baseline to end of study (total study duration 20 weeks) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Quality of Relationship With Partner as Measured by GAQ Question 4 | 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). | Posted | Mean | Standard Deviation | units on a scale | 4-12 weeks from baseline to end of study (total study duration 20 weeks) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | FSDS-DAO Total Score | 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. | Posted | Mean | Standard Deviation | units on a scale | 4 - 12 weeks from baseline to end of study (total study duration 20 weeks) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | identical formulation without active ingredient | 3 | 97 | 49 | 97 | ||
| EG001 | Bremelanotide Arm 1 | low dose 0.75 mg BMT | 1 | 100 | 64 | 100 | ||
| EG002 | Bremelanotide Arm 2 | middle dose 1.25 mg BMT | 1 | 99 | 61 | 99 | ||
| EG003 | Bremelanotide Arm 3 | high dose 1.75 mg BMT | 1 | 98 | 67 | 98 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Escherichia bacteremia | Infections and infestations | MedDRA 14 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 14 | Non-systematic Assessment |
| |
| Menometrorrhagia | Reproductive system and breast disorders | MedDRA 14 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 14 | Non-systematic Assessment |
| |
| Incisional hernia | Surgical and medical procedures | MedDRA 14 | Non-systematic Assessment |
| |
| Chest pain | Cardiac disorders | MedDRA 14 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 14 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 14 | Non-systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 14 | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 14 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14 | Non-systematic Assessment |
| |
| Injection/vessel puncture site hematoma (1% each) | General disorders | MedDRA 14 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 14 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 14 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14 | Non-systematic Assessment |
| |
| Paresthesia | Nervous system disorders | MedDRA 14 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 14 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 14 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 14 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 14 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 14 | Non-systematic Assessment |
| |
| Abdominal pain/discomfort, lower/upper abdominal pain, dyspepsia (1% each) | Gastrointestinal disorders | MedDRA 14 | Non-systematic Assessment |
| |
| Feeling hot/jittery, inj site reac/hemorrhage/rash, pain, chest pain (1% each) | General disorders | MedDRA 14 | Non-systematic Assessment |
| |
| Fungal infect, gastroenter/bronchitis, vulvo/vaginitis, follicul/pharyngitis, tooth abcess (1% each) | Infections and infestations | MedDRA 14 | Non-systematic Assessment |
| |
| Migraine, sciatica, sinus headache (1% each) | Nervous system disorders | MedDRA 14 | Non-systematic Assessment |
| |
| Hematoma, hot flush (1% each) | Vascular disorders | MedDRA 14 | Non-systematic Assessment |
| |
| Musculoskeletal pain/myalgia, arthralgia, muscle spasms, flank pain (1% each) | Musculoskeletal and connective tissue disorders | MedDRA 14 | Non-systematic Assessment |
| |
| Vag hemorrh/discharge, breast tend/mass, metrorrhagia, menstru irreg, genit discomfort/order (1% ea) | Reproductive system and breast disorders | MedDRA 14 | Non-systematic Assessment |
| |
| CPK/glu/lipase/chol/BP/triglycerides increased, iron decreased, MCV abnormal (1% each) | Investigations | MedDRA 14 | Non-systematic Assessment |
| |
| Acne, pruritis, dermatitis contact, erythema, rash, urticaria (1% each) | Skin and subcutaneous tissue disorders | MedDRA 14 | Non-systematic Assessment |
| |
| Contusion, fall, joint sprain, procedural dizziness/pain, thermal pain (1% each) | Injury, poisoning and procedural complications | MedDRA 14 | Non-systematic Assessment |
| |
| Cough, nasal/sinus congestion (1% each) | Respiratory, thoracic and mediastinal disorders | MedDRA 14 | Non-systematic Assessment |
| |
| Insomnia, libido increased, restlessness (1% each) | Psychiatric disorders | MedDRA 14 | Non-systematic Assessment |
| |
| Hypersensitivity, seasonal allergy (1% each) | Immune system disorders | MedDRA 14 | Non-systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA 14 | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 14 | Non-systematic Assessment |
| |
| Melanocytic nevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Edelson, MD, FRCPC | Palatin Technologies, Inc. | (609) 495-2200 | jedelson@palatin.com |
| ID | Term |
|---|---|
| D020018 | Sexual Dysfunctions, Psychological |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C476721 | bremelanotide |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| Other |
|
| Unknown or Not Reported |
|
| Surgically Sterile |
|
| Data Missing |
|
| >143 - 165 pounds |
|
| >165 - 200.6 pounds |
|
| >200.6 - 350 pounds |
|
| Data Missing |
|
| Regular |
|
| Variable cycle length (>7 days different from nor |
|
| 2 or more skipped cycles, and amenorrhea for 60 or |
|
| N.A. |
|
| Other Than Red |
|
| HSDD |
|
| Mixed FSAD/HSDD |
|
| No |
|
| <0.05 |
| Mean Difference (Final Values) |
| 0.0012 |
| Standard Deviation |
| 0.0012 |
| 2-Sided |
| 95 |
| 0.00 |
| 0.06 |
| No |
| Superiority or Other |
| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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|
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| Units | Counts |
|---|---|
| Participants |
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|
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| Units | Counts |
|---|---|
| Participants |
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