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

Phase 2

Terminated

• Conditions: Vasomotor Symptoms (VMS)
• Interventions: Drug: AR08; Drug: Placebo

• Registration Number: NCT02049164
• Lead Sponsor: Arbor Pharmaceuticals, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-28
• Study First Submitted QC: 2014-01-28
• Study First Posted: 2014-01-30
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Disposition First Submitted: 2015-06-05
• Disposition First Submitted QC: 2015-06-05
• Disposition First Posted: 2015-07-03
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-10
• Last Update Posted: 2015-12-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AR08 1.0 mg/day	AR08	AR08 QD oral dosing for 14 weeks
AR08 2.0 mg/day	AR08	AR08 QD oral dosing for 14 weeks
AR08 0.5 mg/day	AR08	AR08 QD oral dosing for 14 weeks
Placebo	Placebo	Placebo QD oral dosing for 14 weeks

Primary Outcome Measures

Name	Time	Method
Mean change from Baseline in the frequency and severity of moderate to severe hot flashes	Weeks 4 and 12

Secondary Outcome Measures

Name	Time	Method
Patient Global Impression - Improvement (PGI-I)	Weeks 4, 8, and 12

Trial Locations

Locations (15)

Genesis Center for Clinical Research; 🇺🇸 San Diego, California, United States

Clinical Research Advantage, Inc.; 🇺🇸 Colorado Springs, Colorado, United States

Blue Skies Center for Women; 🇺🇸 Colorado Springs, Colorado, United States

Altus Research; 🇺🇸 Lakeworth, Florida, United States

OB-GYN Associates of Mid-Florida, P.A.; 🇺🇸 Leesburg, Florida, United States

Comprehensive Clinical Trials, LLC; 🇺🇸 West Palm Beach, Florida, United States

Cypress Medical Research Center; 🇺🇸 Wichita, Kansas, United States

Clinical Research Center of Nevada; 🇺🇸 Las Vegas, Nevada, United States

Lawrence OB/Gyn Associates; 🇺🇸 Lawrenceville, New Jersey, United States

Hawthorne Medical Research, Inc.; 🇺🇸 Winston-Salem, North Carolina, United States

Scroll for more (5 remaining)