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

NCT02049164 | Terminated Phase 2

• 1 other identifier: AR08.100
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 15

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.

Conditions

Vasomotor Symptoms (VMS)

Keywords

AR08, Vasomotor Symptoms

Outcome Measures

Primary Outcomes (1)

• Mean change from Baseline in the frequency and severity of moderate to severe hot flashes

  Weeks 4 and 12

Secondary Outcomes (1)

• Patient Global Impression - Improvement (PGI-I)

  Weeks 4, 8, and 12

Study Arms (4)

AR08 0.5 mg/day

EXPERIMENTAL

AR08 QD oral dosing for 14 weeks

Drug: AR08

AR08 1.0 mg/day

EXPERIMENTAL

AR08 QD oral dosing for 14 weeks

Drug: AR08

AR08 2.0 mg/day

EXPERIMENTAL

AR08 QD oral dosing for 14 weeks

Drug: AR08

Placebo

PLACEBO COMPARATOR

Placebo QD oral dosing for 14 weeks

Drug: Placebo

Interventions

AR08 DRUG

AR08 0.5 mg/day; AR08 1.0 mg/day; AR08 2.0 mg/day

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 41 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arbor Pharmaceuticals, Inc.: lead

Study Sites (15)

Genesis Center for Clinical Research

San Diego, California, 92103, United States

Location

Clinical Research Advantage, Inc.

Colorado Springs, Colorado, 80906, United States

Location

Blue Skies Center for Women

Colorado Springs, Colorado, 80910, United States

Location

Altus Research

Lakeworth, Florida, 99461, United States

Location

OB-GYN Associates of Mid-Florida, P.A.

Leesburg, Florida, 34748, United States

Location

Comprehensive Clinical Trials, LLC

West Palm Beach, Florida, 33409, United States

Location

Cypress Medical Research Center

Wichita, Kansas, 67226, United States

Location

Clinical Research Center of Nevada

Las Vegas, Nevada, 89123, United States

Location

Lawrence OB/Gyn Associates

Lawrenceville, New Jersey, 08648, United States

Location

Hawthorne Medical Research, Inc.

Winston-Salem, North Carolina, 27103, United States

Location

Clinical Research of Philadelphia, LLC

Philadelphia, Pennsylvania, 19114, United States

Location

Chattanooga Medical Research, LLC

Chattanooga, Tennessee, 37404, United States

Location

TMC Life Research, Inc.

Houston, Texas, 77054, United States

Location

Tidewater Physicians for Women

Norfolk, Virginia, 23502, United States

Location

Seattle Womens: Health, Research, Gynecology

Seattle, Washington, 98105, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2014
• First Posted: January 30, 2014
• Study Start: January 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: December 9, 2015

Record last verified: 2015-11

Locations

US (15)