Role of the Melanocortin-4 Receptor in Hypoactive Sexual Desire Disorder

Inclusion Criteria

• Heterosexual premenopausal females ≥ 18 years of age with normal menstrual cycles ≤ 35 days.
• Right hand dominant.
• Body mass index (BMI) 18-35kg/m2.
• Currently in a relationship with a male partner and the relationship has been stable for at least 6 months before screening.
• Male sexual partner classified as "not impotent" on the Massachusetts Male Aging Study (MMAS) single-question assessment of erectile dysfunction.
• In the subject's opinion, previously experienced "normal sexual function," defined as a normal level of desire at some point in the past, for a period of at least 2 years.
• For all subjects of childbearing potential who are sexually active, agree to routinely use adequate non-hormonal contraception from randomisation throughout the duration of the study and for 30 days after.
• For at least 6 months before Screening, met the diagnostic criteria for HSDD according to the Diagnostic Screening Guide for HSDD, including categorisation of the sexual dysfunction as both acquired (versus lifelong) and generalised (versus situational).
• All of the following at Screening:
• Patient Health Questionnaire (PHQ-9) (Kroenke et al., 2001) total score is
• Either Female Sexual Function Index (FSFI) total score ≤26 if diagnosed with HSDD (with or without symptoms of decreased arousal) or subjects diagnosed with HSDD only (without symptoms of decreased arousal), FSFI desire domain score of ≤5 (regardless of total FSFI score).
• Female Sexual Distress Scale - Desire/Arousal/Orgasm (FSDS-DAO) total score is >18.
• Capable of understanding and complying with the protocol requirements and available for the duration of the study.
• Subjects must have prior experience in viewing sexually explicit material.

Exclusion Criteria

• Cardiovascular disease
• Current diagnosis of uncontrolled hypertension defined as:
• Two sequential assessments (seated, approximately 4 minutes apart and no more than 15 minutes apart) with readings above 140 mmHg systolic BP or 90 mmHg diastolic BP, and upon repeat at least 24 hours later.
• Treatment for hypertension that has been changed at least once in the 4 weeks prior to Screening.
• Any other medical condition that is unstable or uncontrolled despite current therapy.
• Previously received Bremelanotide.
• A history of unresolved sexual trauma or abuse.
• Female subjects who are pregnant, intend to become pregnant, are breastfeeding, have a positive serum/urine pregnancy test, or are not willing to use effective contraceptive precautions during the study.
• Participated in any research study within the preceding 30 days of screening.
• Any FSD other than acquired HSDD with or without decreased arousal (e.g. lifelong anorgasmia, sexual pain disorder, sexual aversion disorder, primary female sexual arousal disorder).
• FSD caused by untreated endocrine disease (e.g. hypopituitarism, hypothyroidism, diabetes mellitus).
• Acute or chronic hepatitis.
• In the Investigator's opinion, any urologic or gynecologic condition, such as condyloma, uterine fibroids, vulvar or vaginal lesions, vulvodynia, vaginismus, or pelvic pain that may contribute to impaired sexual activity and function or be a cause of the FSD or that may interfere with the subject's ability to comply with study procedures.
• Receiving any treatment for HSDD (e.g. psychotherapy, physical therapy) at the time of Screening.
• Has used any of the following types of medications, which are prohibited during the study:
• Implanted or injected testosterone product within 6 months of Screening.
• Within 3 months of Screening:
• Neuroleptics (e.g. risperidone)
• Lithium (e.g. lithium carbonate)
• Antidepressants (e.g. amitriptyline, fluoxetine, bupropion)
• Mood stabilisers (e.g. valproate)
• Benzodiazepines (e.g. lorazepam, diazepam)
• Cognitive enhancers or stimulants (e.g. donepezil or Adderall®)
• Centrally-acting antihypertensives (e.g. clonidine)
• Any other prescription, non-prescription, hormonal, herba