Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder
Condition: Female Sexual Arousal Disorder; Hypoactive Sexual Desire Disorder
MeSH terms: Hypokinesia; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological
Intervention: bremelanotide
Intervention description: Subjects will administer drug on an as needed basis, prior to anticipated sexual activity.
Investigational product: Bremelanotide aqueous solution for subcutaneous (SC) injection, provided as pre-filled syringes containing 0.75, 1.25, or 1.75 mg in 0.3 mL volume. Subjects will self-administer bremelanotide by SC injection into the anterior thigh or abdomen.
Placebo: Same formulation as the investigation product but without the active ingredient, provided as pre-filled syringes containing 0.3 mL volume. Subjects will self-administer the placebo by SC injection in the same manner as the investigational product.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 612.0
Sex: Female
Minimum age: 21 Years
Healthy volunteers: No
Keywords: FSAD; HSDD; female sexual dysfunction; FSD; Female Sexual Arousal Disorder; Hypoactive Sexual Desire Disorder

Summary:

      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.
    

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.