FP-101 Versus Placebo in the Treatment of Menopausal Vasomotor Symptoms

Completed · Phase 2 · Has a placebo group

Conditions studied: Vasomotor Symptoms, Menopause

In brief

This Phase II proof of concept study is designed to assess the safety and efficacy of FP-101 (60mg b.i.d.), an extended-release oral tablet product, compared to a matching placebo in the treatment of moderate-to-severe hot flashes in peri- and post-menopausal women over a period of 1-week.

Key facts

Study ID

NCT05312567

Run by

Fervent Pharmaceuticals

People needed

105

Starts

2021-03-24

Expected to finish

2023-07-31

Last updated by the study team

2023-10-26

Who can join

Age: 46 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Peri- and Post-Menopausal female subjects (>45 yrs) experiencing a min of 7-8 moderate to severe hot flashes per day
• Able/willing to provide informed consent.
• Able/willing to complete all study procedures and visits.
• Able/willing to not use any over-the-counter (OTC) cough \& cold medications that contain the IMP active during the study.

You may not qualify if…

• Subject exhibits positive home pregnancy test at screening or any time during study
• Subject currently taking any form of Hormone Therapy (HT), including local estrogen therapies
• Subject currently taking tamoxifen, other selective estrogen receptor modulators, or other hormone deprivation therapy.
• Subject with history of serotonergic syndrome
• Subject is currently taking monoamine oxidase inhibitors (MAOIs) (or for 2 weeks after stopping the MAOI drug), antidepressants, thioridazine, pimozide, cannabidiol, opioids, antipsychotic agents, antiretroviral agents, quinidine, quinine, or other medications for VMS such as Brisdelle® (paroxetine mesylate), clonidine and gabapentin.
• Subject is currently taking a dietary/herbal supplement(s) to manage VMS, such as soy isoflavones or black cohosh.
• Subject has uncontrolled diabetes, a history of hypertension \& is not on a stable dose of antihypertensive medications for at least 30 days prior to screening.
• Subject has clinically unstable cardiac disease, including atrial fibrillation, symptomatic brady- or tachy-arrhythmias, congestive heart failure (NYHA class II, III, and IV), or symptomatic atherosclerotic cardiovascular disease (coronary artery disease, carotid artery disease or peripheral artery disease) or history of myocardial infarction or stroke within 2 years of enrolment in the study.
• Subject reports medical history suggestive of impaired liver/kidney function or, in the PI's opinion, exhibits liver/kidney function impairment to the extent that the subject should not participate in the study.
• Subject has biliary tract disease, adrenal cortical insufficiency, or any other medical condition that, in the PI's opinion (and after discussion with the medical monitor), is considered inadequately treated and precludes entry into the study.
• Subject has thyroid disease, unless subject is clinically stable with normal thyroid indices and is on maintenance thyroid medication (e.g., levothyroxine or liothyronine) for ≥6 months prior to screening.
• Subject has a history of, or is currently presenting with, substance use disorder as defined by the 5th Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM). Subject has a history of psychiatric disorders, including a lifetime history of major depressive disorder, bipolar disorder, panic disorder, generalized anxiety, psychotic disorders, suicidality or suicidal ideation, or post-traumatic stress disorder.
• Subject is currently participating in another clinical trial
• Subjects who were determined to be placebo responders or non-compliant during the 1-week run-in period.

Where it is running

• Torrance Clinical Research Institute — Lomita, California, United States
• Long Beach Clinical Trial Services — Long Beach, California, United States
• Provideré Research Inc. — West Covina, California, United States
• Inpatient Research Clinic — Hialeah, Florida, United States
• The Angel Medical Research Corporation — Miami Lakes, Florida, United States
• Suncoast Clinical Research - Pasco County — New Port Richey, Florida, United States
• Cary Medical Group — Cary, North Carolina, United States
• Raleigh Medical Group — Raleigh, North Carolina, United States
• Clinical Research of Philadelphia — Philadelphia, Pennsylvania, United States
• Coastal Carolina Research Center — North Charleston, South Carolina, United States
• ICON Early Phase Services — San Antonio, Texas, United States
• Discovery Clinical Trials - Stone Oak — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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