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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02049164

Enrollment

Registered

2014-01-30

Start date

2014-01-31

Completion date

2014-05-31

Last updated

2015-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vasomotor Symptoms (VMS)

Keywords

AR08, Vasomotor Symptoms

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.

Interventions

DRUGAR08

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

41 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026