Clinical trial NCT02049164: Safety and Efficacy Study of AR08 for the Treatment of Vasomotor Symptoms (VMS)
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Vasomotor Symptoms (VMS)
Keywords: AR08, Vasomotor Symptoms
Lead sponsor: Arbor Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2014-01-30
Enrollment: 32
Sex: FEMALE
Minimum age (years): 41
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean change from Baseline in the frequency and severity of moderate to severe hot flashes
timeFrame: Weeks 4 and 12
Secondary outcomes:
measure: Patient Global Impression - Improvement (PGI-I)
timeFrame: Weeks 4, 8, and 12
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Genesis Center for Clinical Research
state: California
city: Colorado Springs
country: United States
facility: Clinical Research Advantage, Inc.
state: Colorado
city: Colorado Springs
country: United States
facility: Blue Skies Center for Women
state: Colorado
city: Lakeworth
country: United States
facility: Altus Research
state: Florida
city: Leesburg
country: United States
facility: OB-GYN Associates of Mid-Florida, P.A.
state: Florida
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Trials, LLC
state: Florida
city: Wichita
country: United States
facility: Cypress Medical Research Center
state: Kansas
city: Las Vegas
country: United States
facility: Clinical Research Center of Nevada
state: Nevada
city: Lawrenceville
country: United States
facility: Lawrence OB/Gyn Associates
state: New Jersey
city: Winston-Salem
country: United States
facility: Hawthorne Medical Research, Inc.
state: North Carolina
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia, LLC
state: Pennsylvania
city: Chattanooga
country: United States
facility: Chattanooga Medical Research, LLC
state: Tennessee
city: Houston
country: United States
facility: TMC Life Research, Inc.
state: Texas
city: Norfolk
country: United States
facility: Tidewater Physicians for Women
state: Virginia
city: Seattle
country: United States
facility: Seattle Womens: Health, Research, Gynecology
state: Washington
Study officials:
References: