Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder
NCT ID: NCT01382719
Last Updated: 2014-12-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
612 participants
INTERVENTIONAL
2011-06-30
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
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.
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.
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.
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.
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.
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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
21 Years
FEMALE
No
Sponsors
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Palatin Technologies, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Jeffrey Edelson, MD, FRCPC
Role: STUDY_DIRECTOR
Palatin Technologies, Inc
Locations
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Site 56
Birmingham, Alabama, United States
Site 26
Huntsville, Alabama, United States
Site 64
Mobile, Alabama, United States
Site 45
Chandler, Arizona, United States
Site 39
Phoenix, Arizona, United States
Site 25
Tucson, Arizona, United States
Site 78
Hot Springs, Arkansas, United States
Site 16
Jonesboro, Arkansas, United States
Site 52
National City, California, United States
Site 73
Newport Beach, California, United States
Site 80
Sacramento, California, United States
Site 12
San Diego, California, United States
Site 37
Denver, Colorado, United States
Site 40
Lakewood, Colorado, United States
Site 8
Avon, Connecticut, United States
Site 75
Farmington, Connecticut, United States
Site 33
New London, Connecticut, United States
Site 32
Washington D.C., District of Columbia, United States
Site 10
Aventura, Florida, United States
Site 27
Fort Myers, Florida, United States
Site 66
Melbourne, Florida, United States
Site 61
Orlando, Florida, United States
Site 1
West Palm Beach, Florida, United States
Site 82
Atlanta, Georgia, United States
Site 55
Decatur, Georgia, United States
Site 70
Chicago, Illinois, United States
Site 54
Peoria, Illinois, United States
Site 63
South Bend, Indiana, United States
Site 13
Wichita, Kansas, United States
Site 48
Lexington, Kentucky, United States
Site 57
Zachary, Louisiana, United States
Site 9
Baltimore, Maryland, United States
Site 60
Rockville, Maryland, United States
Site 74
St Louis, Missouri, United States
Site 35
Lincoln, Nebraska, United States
Site 72
Las Vegas, Nevada, United States
Site 24
Las Vegas, Nevada, United States
Site 18
New York, New York, United States
Site 38
Purchase, New York, United States
Site 3
Raleigh, North Carolina, United States
Site 47
Winston-Salem, North Carolina, United States
Site 23
Beachwood, Ohio, United States
Site 69
Canton, Ohio, United States
Site 71
Cincinnati, Ohio, United States
Site 19
Cleveland, Ohio, United States
Site 30
Columbus, Ohio, United States
Site 81
Englewood, Ohio, United States
Site 2
Eugene, Oregon, United States
Site 42
Philadelphia, Pennsylvania, United States
Site 77
Pittsburgh, Pennsylvania, United States
Site 43
Warwick, Rhode Island, United States
Site 58
Greer, South Carolina, United States
Site 49
Mt. Pleasant, South Carolina, United States
Site 53
Chattanooga, Tennessee, United States
Site 59
Corpus Christi, Texas, United States
Site 76
Dallas, Texas, United States
Site 31
Dallas, Texas, United States
Site 17
Houston, Texas, United States
Site 62
San Antonio, Texas, United States
Site 50
Murray, Utah, United States
Site 36
Sandy City, Utah, United States
Site 7
Charlottesville, Virginia, United States
Site 68
Norfolk, Virginia, United States
Site 65
Richmond, Virginia, United States
Site 22
Seattle, Washington, United States
Site 4
North Vancouver, British Columbia, Canada
Site 41
Barrie, Ontario, Canada
Site 21
Burlington, Ontario, Canada
Countries
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References
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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.
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.
Other Identifiers
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PT-141-54
Identifier Type: -
Identifier Source: org_study_id