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Safety and Efficacy Study of AR08 for the Treatment of Vasomotor Symptoms (VMS) | Clinical Trials | Clareo Health

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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

NCT02049164•Arbor Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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

Age

41 - No limit years

Sex

FEMALE

Healthy Volunteers

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

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

Key Dates

Start Date

January 1, 2014

Primary Completion Date

May 1, 2014

Completion Date

May 1, 2014

Last Updated

December 9, 2015

Enrollment

ACTUAL participants

Conditions

Vasomotor Symptoms (VMS)

Interventions

AR08

DRUG

Placebo

DRUG

Long-term Safety and Efficacy Study of MT-8554 in Postmenopausal Women With Vasomotor Symptoms

NCT03541200

Vasomotor Symptoms (VMS)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 9, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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