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

Inclusion Criteria:

Is female, at least 21 years of age, and premenopausal Has previously experienced sexual arousal during sexual activity and/or a normal level of desire at some point in the past for a period of at least 2 years.

Is willing to engage in sexual activities Is currently in a 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" for him on Single-question Assessment of Erectile Dysfunction.

For at least 6 months before Screening, has met the diagnostic criteria for FSAD, HSDD, or mixed FSAD/HSDD Has a negative serum pregnancy test (hCG) at Screening and, if the subject's partner is male, subject has used a medically acceptable form of contraception for the 3 months before Screening (Visit 1), and is willing to continue using an acceptable form of contraception for the duration of the trial and for 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 human papillomavirus (HPV), dysplasia, or atypical squamous cells of undetermined significance (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 the necessary questionnaire scores.

Exclusion Criteria:

Has any medical condition that is unstable or uncontrolled despite current therapy.

Has history of unresolved sexual trauma or abuse. Is pregnant or nursing. Has lifelong anorgasmia, vaginismus, sexual pain disorder, sexual aversion disorder, or persistent sexual arousal disorder.

Has female sexual dysfunction caused by untreated endocrine disease; for example, hypopituitarism, hypothyroidism, diabetes mellitus.

Has or has ever had any of the following:history of hepatitis C, other infectious hepatitis, or infectious blood disorders such as human immunodeficiency virus (HIV); myocardial infarction;stroke.

Has or has had any of the following within the 12 months before Screening:chronic dyspareunia not attributable to vaginal dryness; pelvic inflammatory disease; chronic or complicated urinary tract infection, or an active sexually transmitted disease (STD) other than herpes and condyloma; cervical dysplasia, including low- and high-grade squamous intraepithelial lesion (LGSIL and HGSIL, respectively) and/or ASCUS with HPV; significant cervicitis as manifested by mucopurulent discharge from the cervix.

Has had any of the following within the 6 months before Screening:≥ 2 outbreaks of genital herpes in 6 months; occurrence/recurrence of clinically significant condyloma;clinically unstable angina or clinically unstable arrhythmia;significant central nervous system diseases, such as spinal cord injury or multiple sclerosis;aspartate aminotransferase (AST) or alanine aminotransferase (ALT) concentrations > 3 times the upper limit of normal;serum creatinine > 2.5 mg/dL;any other clinically significant abnormal laboratory test result.

Has used any of the types of medications which are prohibited 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 the 6 months before Screening.

Is currently receiving psychotherapy for the treatment of FSAD and/or HSDD. Has any of the following (subject may rescreen once for failure to meet these criteria at Screening):Current diagnosis of uncontrolled hypertension;Systolic BP of ≥ 140 mm Hg at Screening;Diastolic BP of ≥ 90 mm Hg at Screening; Treatment for hypertension that has been changed at least once 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 which have affected the menstrual cycle or caused amenorrhea AND did not have a normal menstrual cycle before starting the contraceptive medication.