Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder

Completed · Phase 2 · Has a placebo group

Conditions studied: Female Sexual Arousal Disorder, Hypoactive Sexual Desire Disorder

In brief

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.

Key facts

Study ID

NCT01382719

Run by

Palatin Technologies, Inc

People needed

612

Starts

2011-06-01

Expected to finish

2012-09-01

Last updated by the study team

2014-12-18

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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 56 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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