NCT02049164TerminatedPhase 2
A Randomized, Double-blind, Placebo-controlled, Forced Titration, Dose-ranging Study of AR08 in the Treatment of Vasomotor Symptoms (VMS) in Menopausal Females: A Proof-of-Concept Study
Arbor Pharmaceuticals, Inc.15 sites in 1 country32 target enrollmentStarted: January 2014Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Arbor Pharmaceuticals, Inc.
- Enrollment
- 32
- Locations
- 15
- Primary Endpoint
- Mean change from Baseline in the frequency and severity of moderate to severe hot flashes
Study Overview
Brief Summary
The purpose of this study is to determine the effective dose or dose range of AR08 in the treatment of VMS in menopausal females.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 41 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Generally healthy female > 40 years of age with a body mass index (BMI) ≤ 40;
- •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);
- •Experience a minimum of 7 moderate to severe hot flushes per day or 50 moderate to severe hot flushes per week
Exclusion Criteria
- •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;
- •Subjects with pre-existing orthostatic hypotension at Screening;
- •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;
- •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
Arms & Interventions
AR08 0.5 mg/day
Experimental
AR08 QD oral dosing for 14 weeks
Intervention: AR08 (Drug)
AR08 1.0 mg/day
Experimental
AR08 QD oral dosing for 14 weeks
Intervention: AR08 (Drug)
AR08 2.0 mg/day
Experimental
AR08 QD oral dosing for 14 weeks
Intervention: AR08 (Drug)
Placebo
Placebo Comparator
Placebo QD oral dosing for 14 weeks
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Mean change from Baseline in the frequency and severity of moderate to severe hot flashes
Time Frame: Weeks 4 and 12
Secondary Outcomes
- Patient Global Impression - Improvement (PGI-I)(Weeks 4, 8, and 12)
Investigators
Study Sites (15)
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