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Vasomotor SymptomsPhase 2NCT05312567

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

A Phase 2 study testing FP-101 in people with Vasomotor Symptoms and Menopause, run by Fervent Pharmaceuticals at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 46 years and older, women only
Conditions the study is for
Vasomotor Symptoms, Menopause
What is being tested?
FP-101
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
105 participants
Where
12 sitesUnited States
Study dates
24 Mar 2021to 31 Jul 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 46 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • Cary Medical Group

    Cary, North Carolina, 27518

  • Inpatient Research Clinic

    Hialeah, Florida, 33013

  • Torrance Clinical Research Institute

    Lomita, California, 90717

  • Long Beach Clinical Trial Services

    Long Beach, California, 90806

  • The Angel Medical Research Corporation

    Miami Lakes, Florida, 33016

  • Suncoast Clinical Research - Pasco County

    New Port Richey, Florida, 34652

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405

  • Clinical Research of Philadelphia

    Philadelphia, Pennsylvania, 19114

  • Raleigh Medical Group

    Raleigh, North Carolina, 27609

  • ICON Early Phase Services

    San Antonio, Texas, 78209

  • Discovery Clinical Trials - Stone Oak

    San Antonio, Texas, 78258

  • Provideré Research Inc.

    West Covina, California, 91790

Other trials in United States

About this study

Official title: Randomized, Double-Blind, Plac.-Controlled Clinical Study to Compare the Efficacy of FP-101 60mg b.i.d. vs. Placebo for the Treatment of Moderate-to-Severe Hot Flashes in Peri- and Post-menopausal Women Over a Period of 1-Week.

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.

Read the detailed description

This randomized, double-blind, parallel-group, placebo-controlled, clinical trial is designed to compare patient-reported changes in Vasomotor Symptoms (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 electronic Consent (eConsent), mobile/tele health visits, electronic Patient Reported Outcomes (ePROs), and direct-to-participant shipping of the (investigational medicinal product (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 Good Clinical Practice (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 Adverse Events (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 electronic Diary (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.

------------------------------

Being tested
FP-101

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FP-101Drug

    daily oral tablet administration (b.i.d.)

Study groups in NCT05312567
Study groupRoleWhat they receive
Active Treatment (FP-101)ExperimentalWhite to off-white extended-release, round tablets containing FP-101.
Receives: Drug: FP-101
Matching placeboPlacebo comparatorWhite to off-white round tablets without the active ingredient but otherwise matching in size and appearance.
Receives: Drug: FP-101

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Subjects use a digital platform to record hot flash frequency in a daily eDiary.

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

Secondary outcomes (3)

  1. Change in the severity (average daily rating) of moderate-to-severe hot flashes.

    Subjects use digital platform to record hot flash severity (3-point scale) in a daily eDiary.

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

  2. Change in nighttime awakenings (average daily number) with or without night sweats.

    Subjects use daily eDiary to record nighttime awakenings \& night sweats frequency.

    Measured: Recorded every morning over a 1-week treatment period.

  3. Evaluate the clinical meaningfulness of VMS changes after 1-week of treatment.

    Completing validated Patient Global Improvement Scale (7-point) with PI.

    Measured: After 1 week of treatment at the end-of-study visit.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2022
  2. Study start24 Mar 2021
  3. Primary completion5 Apr 2023
  4. Study completion31 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, double-blind, parallel-group, placebo-controlled study to compare patient-reported changes in VMS for the IMP vs. placebo. The study will be run as a fully decentralized clinical trial.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05312567
Sponsor's protocol ID
2021-FERV
Status last verified
Oct 2023
First submitted
28 Mar 2022
Last updated
26 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: No plans to share data with other researchers

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FP-101 in people with Vasomotor Symptoms and Menopause, run by Fervent Pharmaceuticals at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the frequency (average daily number) of moderate-to-severe hot flashes. (time frame: Recorded every 12 hrs over a 1-week treatment period.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05312567.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.

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