TerminatedPhase 2

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

Stopped: Study stopping criteria met with regards to vital sign measurements post dose.

United States32 participantsStarted 2014-01

Plain-language 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.

Who can participate

Age range

41 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Generally healthy female \> 40 years of age with a body mass index (BMI) ≤ 40;
. Has undergone menopause defined as any of the following:
. Experience a minimum of 7 moderate to severe hot flushes per day or 50 moderate to severe hot flushes per week

Exclusion criteria

. 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;
. Subjects with pre-existing orthostatic hypotension at Screening;
. 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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean change from Baseline in the frequency and severity of moderate to severe hot flashes

Timeframe: Weeks 4 and 12

Trial details

NCT IDNCT02049164

SponsorArbor Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-05

View on ClinicalTrials.gov More Vasomotor Symptoms (VMS) trials