Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder
Launched by PALATIN TECHNOLOGIES, INC · Jun 24, 2011
Trial Information
Current as of June 05, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
FEMALE
Eligibility 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.
About Palatin Technologies, Inc
Palatin Technologies, Inc. is a biopharmaceutical company focused on developing innovative therapeutics to address unmet medical needs in various therapeutic areas, including sexual health, obesity, and cardiovascular conditions. With a strong emphasis on peptide-based drug development, Palatin leverages its proprietary technology platform to advance novel treatments through clinical trials. The company's commitment to scientific excellence and patient-centered solutions positions it as a leader in the biopharmaceutical industry, dedicated to improving patient outcomes and enhancing quality of life through groundbreaking therapies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Birmingham, Alabama, United States
Huntsville, Alabama, United States
Mobile, Alabama, United States
Chandler, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Hot Springs, Arkansas, United States
Jonesboro, Arkansas, United States
National City, California, United States
Newport Beach, California, United States
Sacramento, California, United States
San Diego, California, United States
Denver, Colorado, United States
Lakewood, Colorado, United States
Avon, Connecticut, United States
Farmington, Connecticut, United States
New London, Connecticut, United States
Washington, District Of Columbia, United States
Aventura, Florida, United States
Fort Myers, Florida, United States
Melbourne, Florida, United States
Orlando, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Chicago, Illinois, United States
Peoria, Illinois, United States
South Bend, Indiana, United States
Wichita, Kansas, United States
Lexington, Kentucky, United States
Zachary, Louisiana, United States
Baltimore, Maryland, United States
Rockville, Maryland, United States
St. Louis, Missouri, United States
Lincoln, Nebraska, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
New York, New York, United States
Purchase, New York, United States
Raleigh, North Carolina, United States
Winston Salem, North Carolina, United States
Beachwood, Ohio, United States
Canton, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Englewood, Ohio, United States
Eugene, Oregon, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Warwick, Rhode Island, United States
Greer, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Chattanooga, Tennessee, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Murray, Utah, United States
Sandy, Utah, United States
Charlottesville, Virginia, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Seattle, Washington, United States
North Vancouver, British Columbia, Canada
Barrie, Ontario, Canada
Burlington, Ontario, Canada
Patients applied
Trial Officials
Jeffrey Edelson, MD, FRCPC
Study Director
Palatin Technologies, Inc
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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