Safety and Efficacy Study of AR08 for the Treatment of Vasomotor Symptoms (VMS)

Arbor Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Vasomotor Symptoms (VMS)

Treatments: Drug: AR08; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02049164

AR08.100

Details and patient eligibility

About

The purpose of this study is to determine the effective dose or dose range of AR08 in the treatment of VMS in menopausal females.

Enrollment: 32 patients

Sex: Female

Ages: 41+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Generally healthy female > 40 years of age with a body mass index (BMI) ≤ 40;

2. Has undergone menopause defined as any of the following:

   At least 12 months of spontaneous amenorrhea; or At least 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL; or At least 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy);

3. Experience a minimum of 7 moderate to severe hot flushes per day or 50 moderate to severe hot flushes per week

Exclusion criteria

1. Resting systolic blood pressure (SBP) <110 mmHg, resting diastolic blood pressure (DBP) <50 mm Hg, or a resting heart rate (HR) <60 beats per minute while awake;
2. Subjects with pre-existing orthostatic hypotension at Screening;
3. Use of oral estrogen-, progestin-, androgen-, or selective estrogen receptor modifier (SERM) -containing drug products within 8 weeks prior to Screening; use of transdermal hormone products within 8 weeks prior to Screening; use of vaginal hormone products (rings, creams, gels) within 4 weeks prior to Screening; use of intrauterine progestins within 8 weeks prior to Screening; use of progestin implants or estrogen injectables within 3 months prior to Screening; use of estrogen pellet or progestin injectables within 6 months prior to Screening;
4. History of daily usage (at least 28 days/month) of either of the following during the month prior to initiation of Screening: Antihypertensives or Prophylactic antimigraine medications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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32 participants in 4 patient groups, including a placebo group

AR08 0.5 mg/day

Experimental group

Description:

AR08 QD oral dosing for 14 weeks

Treatment:

Drug: AR08

AR08 1.0 mg/day

Experimental group

Description:

AR08 QD oral dosing for 14 weeks

Treatment:

Drug: AR08

AR08 2.0 mg/day

Experimental group

Description:

AR08 QD oral dosing for 14 weeks

Treatment:

Drug: AR08

Placebo

Placebo Comparator group

Description:

Placebo QD oral dosing for 14 weeks

Treatment:

Drug: Placebo