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Search / Trial NCT01382719

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

Fsad Hsdd Female Sexual Dysfunction Fsd Female Sexual Arousal Disorder Hypoactive Sexual Desire Disorder

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.

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

0 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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