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

Vasomotor Symptoms (VMS) Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02049164
• Other study ID #: AR08.100
• Status: Terminated
• Phase: Phase 2
• First received: January 28, 2014
• Last updated: November 10, 2015
• Start date: January 2014
• Est. completion date: May 2014

Study information

• Verified date: November 2015
• Source: Arbor Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 41 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vasomotor Symptoms (VMS)

Intervention

Drug:
• AR08

• Placebo

Locations

Country	Name	City	State
United States	Chattanooga Medical Research, LLC	Chattanooga	Tennessee
United States	Blue Skies Center for Women	Colorado Springs	Colorado
United States	Clinical Research Advantage, Inc.	Colorado Springs	Colorado
United States	TMC Life Research, Inc.	Houston	Texas
United States	Altus Research	Lakeworth	Florida
United States	Clinical Research Center of Nevada	Las Vegas	Nevada
United States	Lawrence OB/Gyn Associates	Lawrenceville	New Jersey
United States	OB-GYN Associates of Mid-Florida, P.A.	Leesburg	Florida
United States	Tidewater Physicians for Women	Norfolk	Virginia
United States	Clinical Research of Philadelphia, LLC	Philadelphia	Pennsylvania
United States	Genesis Center for Clinical Research	San Diego	California
United States	Seattle Womens: Health, Research, Gynecology	Seattle	Washington
United States	Comprehensive Clinical Trials, LLC	West Palm Beach	Florida
United States	Cypress Medical Research Center	Wichita	Kansas
United States	Hawthorne Medical Research, Inc.	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Arbor Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from Baseline in the frequency and severity of moderate to severe hot flashes		Weeks 4 and 12	No
Secondary	Patient Global Impression - Improvement (PGI-I)		Weeks 4, 8, and 12	No