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

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

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 Overview

• Status: Terminated
• Conditions: Vasomotor Symptoms (VMS)
• Intervention / Treatment: Drug: Placebo; Drug: AR08

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92103
      • Genesis Center for Clinical Research
  • Colorado
    • Colorado Springs, Colorado, United States, 80906
      • Clinical Research Advantage, Inc.
    • Colorado Springs, Colorado, United States, 80910
      • Blue Skies Center for Women
  • Florida
    • Lakeworth, Florida, United States, 99461
      • Altus Research
    • Leesburg, Florida, United States, 34748
      • OB-GYN Associates of Mid-Florida, P.A.
    • West Palm Beach, Florida, United States, 33409
      • Comprehensive Clinical Trials, Llc
  • Kansas
    • Wichita, Kansas, United States, 67226
      • Cypress Medical Research Center
  • Nevada
    • Las Vegas, Nevada, United States, 89123
      • Clinical Research Center Of Nevada
  • New Jersey
    • Lawrenceville, New Jersey, United States, 08648
      • Lawrence OB/GYN Associates
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Hawthorne Medical Research, Inc.
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19114
      • Clinical Research Of Philadelphia, Llc
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Chattanooga Medical Research, Llc
  • Texas
    • Houston, Texas, United States, 77054
      • TMC Life Research, Inc.
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Tidewater Physicians for Women
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Womens: Health, Research, Gynecology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AR08 0.5 mg/day; AR08 QD oral dosing for 14 weeks	Drug: AR08
Experimental: AR08 1.0 mg/day; AR08 QD oral dosing for 14 weeks	Drug: AR08
Experimental: AR08 2.0 mg/day; AR08 QD oral dosing for 14 weeks	Drug: AR08
Placebo Comparator: Placebo; Placebo QD oral dosing for 14 weeks	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Arbor Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: January 28, 2014
• First Submitted That Met QC Criteria: January 28, 2014
• First Posted (Estimate): January 30, 2014

Study Record Updates

• Last Update Posted (Estimate): December 9, 2015
• Last Update Submitted That Met QC Criteria: November 10, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: AR08, Vasomotor Symptoms
• Other Study ID Numbers: AR08.100