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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    100
  • sponsor
    Fervent Pharmaceuticals
Updated on 18 May 2022
hot flashes

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.

Description

This randomized, double-blind, parallel-group, placebo-controlled, clinical trial is designed to compare patient-reported changes in VMS for FP-101 vs. placebo in peri- and post-menopausal women. The study will be run as a fully decentralized clinical trial (DCT), by use of components such as eConsent, mobile/tele health visits, ePROs, and direct-to-participant shipping of the IMP. The DCT approach to this study will rely on a digital platform through which subjects can consent, enroll, and interact with the PI and study staff. Proper regulatory framework and technology use will ensure compliance with GCP, ethics & legal/regulatory requirements.

Healthy peri- and post-menopausal women (>45 years of age) suffering from VMS will be recruited if they have >=7- 8 moderate to severe hot flushes per day at baseline. After meeting all eligibility criteria subjects will be enrolled and start a 1-week run-in period to identify/eliminate placebo responders, as well as to exclude subjects who have difficulty completing the eDiary. Any AEs during the run-in period will serve as baseline for the safety assessments at the end of the treatment period.

Eligible subjects will undergo a tele-health baseline visit during which the criteria for inclusion in the treatment period will be confirmed. Over a 1-week treatment period, subjects will complete a daily eDiary to record any AEs and the frequency and severity of hot flashes during the past 12hr interval. In the morning, subjects will record the number of awakenings during the past night and the number of night sweats.

The PI will conduct an end-of-study visit with each of the subjects randomized to the study medications to review safety and efficacy data, complete a Patient Global Improvement Scale, and clarify any open issues with the subjects.


Details
Condition Vasomotor Symptoms, Menopause
Treatment FP-101
Clinical Study IdentifierNCT05312567
SponsorFervent Pharmaceuticals
Last Modified on18 May 2022

Eligibility

Yes No Not Sure

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 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 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 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 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
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