Safety & Efficacy Study of AR08 for the Treatment of Vasomotor Symptoms

Clinical Trial Description

n/a

Study Design

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

See also
Status	Clinical Trial	Phase
Completed	`NCT03518138` - Safety/Efficacy of Q-122 in Breast Cancer Patients Taking Tamoxifen or Aromatase Inhibitor	Phase 2
Completed	`NCT04080297` - Dose Escalation Study in Female Subjects With Breast Cancer Receiving Aromatase Inhibitor or Tamoxifen	Phase 1
Completed	`NCT03541200` - Long-term Safety and Efficacy Study of MT-8554 in Postmenopausal Women With Vasomotor Symptoms	Phase 2

See also

Status

Clinical Trial

Phase

Completed

NCT03518138 - Safety/Efficacy of Q-122 in Breast Cancer Patients Taking Tamoxifen or Aromatase Inhibitor

Phase 2

Completed

NCT04080297 - Dose Escalation Study in Female Subjects With Breast Cancer Receiving Aromatase Inhibitor or Tamoxifen

Phase 1

Completed

NCT03541200 - Long-term Safety and Efficacy Study of MT-8554 in Postmenopausal Women With Vasomotor Symptoms

Phase 2

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT02049164
Study type	Interventional
Source	Arbor Pharmaceuticals, Inc.
Contact
Status	Terminated
Phase	Phase 2
Start date	January 2014
Completion date	May 2014

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms