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

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

Official Title
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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

Conditions
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Vasomotor Symptoms (VMS)

Intervention / Treatment
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* Drug: AR08
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 41 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AR08 0.5 mg/day<br>AR08 QD oral dosing for 14 weeks | Drug: AR08<br> <br> |
| Experimental: AR08 1.0 mg/day<br>AR08 QD oral dosing for 14 weeks | Drug: AR08<br> <br> |
| Experimental: AR08 2.0 mg/day<br>AR08 QD oral dosing for 14 weeks | Drug: AR08<br> <br> |
| Placebo Comparator: Placebo<br>Placebo QD oral dosing for 14 weeks | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from Baseline in the frequency and severity of moderate to severe hot flashes |  | Weeks 4 and 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Global Impression - Improvement (PGI-I) |  | Weeks 4, 8, and 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AR08, Vasomotor Symptoms