CompletedPhase 2

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

United States105 participantsStarted 2021-03-24

Plain-language summary

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.

Who can participate

Age range

46 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: * 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. Exclusion Criteria: * 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 hea…

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

Change in the frequency (average daily number) of moderate-to-severe hot flashes.

Timeframe: Recorded every 12 hrs over a 1-week treatment period.

Trial details

NCT IDNCT05312567

SponsorFervent Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-04-05

View on ClinicalTrials.gov More Vasomotor Symptoms trials