Hot FlashesPhase 2NCT03285672
FP-101 for the Treatment of Hot Flashes in Postmenopausal Women
A Phase 2 study testing FP-101 in people with Hot Flashes, run by Fervent Pharmaceuticals at 12 sites in United States.
Trial summary
The purpose of the study is to determine the efficacy of FP-101 versus placebo for the treatment of hot flashes in postmenopausal women. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Hot Flashes
- What is being tested?
- FP-101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 12 sitesUnited States
- Study dates
- 26 Mar 2018to 29 Oct 2018
- 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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects may be enrolled in the main study only if they meet all of the following criteria:
- Subject must be a female >40 years of age at screening.
- Subject must have reported more than 7 to 8 moderate-to-severe hot flashes per day or 50 to 60 hot flashes per week for at least 30 days prior to the Screening Visit of sufficient severity to cause desire for therapeutic intervention.
- Subject must meet 1 of the following criteria:
- Spontaneous amenorrhea for at least 12 consecutive months.
- Amenorrhea for at least 6 months and meet the biochemical criteria for menopause (FSH ≥40 mIU/mL).
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- Bilateral oophorectomy or salpingo-oophorectomy ≥6 weeks prior to enrollment with or without hysterectomy.
- A subject who is not at least 2 years postmenopausal must use adequate nonhormonal contraception (eg, barrier methods such as an intrauterine device, diaphragm, cervical cap, or condom) during study participation.
- Subject must be willing and able to be compliant with the protocol and provide a voluntary written informed consent.
Who cannot join
- Subject has a history of hypersensitivity or adverse reaction to FP-101 or its excipients
- Subject is a known non-responder to previous SSRI or SNRI treatment for VMS
- Subject has a history of self-injurious behavior.
- Subject has a lifetime history of a clinical diagnosis of major depression or treatment for major depressive disorder.
- Subject has a history of clinical diagnosis of borderline personality disorder.
- 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 (DSM-5).
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- 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 has a history of hypertension and is not on a stable dose of antihypertensive medications for at least 30 days prior to screening.
- Subject is currently taking MAOIs, thioridazine, or pimozide.
- Subject is currently taking tamoxifen, other selective estrogen receptor modulators, or other hormone deprivation therapy.
- Subject exhibits evidence of impaired liver function upon entry into the study (values ≥2 times the upper limit of normal for aspartate transaminase and/or alanine transaminase, or serum bilirubin ≥1.3 mg/dL) or, in the Investigator's opinion, exhibits liver function impairment to the extent that the subject should not participate in the study.
- Subject has clinically unstable cardiac disease, including unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia.
- Subject exhibits evidence of impaired kidney function upon entry into the study (i.e., serum creatinine >1.5 mg/dL) or known renal stricture.
- Subject has biliary tract disease, adrenal cortical insufficiency, or any other medical condition that, in the Investigator's opinion, is 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 exhibits a positive urine pregnancy test result at screening or at any time during study
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
PMG Research of Bristol, LLC
Bristol, Tennessee, 37620
PMG Research of Cary, LLC
Cary, North Carolina, 27518
PMG Research of Christie Clinic, LLC
Champaign, Illinois, 61820
PMG Research of Charlotte, LLC
Charlotte, North Carolina, 28209
PMG Research of Hickory, LLC
Hickory, North Carolina, 28601
PMG Research of Charleston, LLC
Mt. Pleasant, South Carolina, 29464
PMG Research of Knoxville
Oak Ridge, Tennessee, 37830
PMG Research of Raleigh, LLC
Raleigh, North Carolina, 27609
Nash OB/GYN
Rocky Mount, North Carolina, 27804
PMG Research of Salisbury, LLC
Salisbury, North Carolina, 28144
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase 2, Randomized, Double-blind, Placebo Controlled, Single Dose-level, Proof-of-concept Study Evaluating FP-101 for the Treatment of Vasomotor Symptoms in Postmenopausal Women
The purpose of the study is to determine the efficacy of FP-101 versus placebo for the treatment of hot flashes in postmenopausal women.
Read the detailed description
Vasomotor symptoms, commonly known as hot flashes or hot flushes, are the most common symptoms experienced by women who are perimenopausal or postmenopausal. FP-101 is postulated to mediate one of the mechanisms thought to drive hot flashes in post-menopausal women. This study will evaluate the efficacy and safety of FP-101 for the treatment of hot flashes in post-menopausal women.
- Conditions
- Hot Flashes
- Being tested
- FP-101, Placebo Comparator
- Keywords
- Hot Flashes, vasomotor symptoms, postmenopausal
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FP-101Drug
Dose 1
Placebo ComparatorDrug
Dose 1
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | FP-101 Receives: Drug: FP-101 |
| Arm 2 | Placebo comparator | Placebo Comparator Receives: Drug: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint for the main study is the change in the frequency of moderate-to-severe hot flashes.
Measured: Baseline to Week 8
Secondary outcomes (3)
Change in the severity of moderate-to-severe hot flashes.
Measured: Baseline to Week 8
Change in the severity of moderate-to-severe hot flashes.
Measured: Baseline to Week 4
Change in the frequency of moderate-to-severe hot flashes.
Measured: Baseline to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start26 Mar 2018
- Primary completion29 Oct 2018
- Study completion29 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fervent Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Responsible party
- Sponsor
- Investigators
- George Raad, Study director, PMG Research of Charlotte, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03285672
- Sponsor's protocol ID
- FERV001
- Status last verified
- Oct 2018
- First submitted
- 14 Sep 2017
- Last updated
- 1 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Placebo Controlled, Single Dose-level, Proof-of-concept Study Evaluating FP-101 for the Treatment of Vasomotor Symptoms in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT03285672
- Acronym / sponsor ID
- FERV001
- Conditions
- Hot Flashes
- Keywords
- Hot Flashes, vasomotor symptoms, postmenopausal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Fervent PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 29 Oct 2018 (actual)
- Study completion
- 29 Oct 2018 (actual)
- First posted
- 18 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine the efficacy of FP-101 versus placebo for the treatment of hot flashes in postmenopausal women.
Detailed description
Vasomotor symptoms, commonly known as hot flashes or hot flushes, are the most common symptoms experienced by women who are perimenopausal or postmenopausal. FP-101 is postulated to mediate one of the mechanisms thought to drive hot flashes in post-menopausal women. This study will evaluate the efficacy and safety of FP-101 for the treatment of hot flashes in post-menopausal women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: FP-101FP-101 |
| Arm 2 | Placebo comparator | Drug: Placebo ComparatorPlacebo Comparator |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects may be enrolled in the main study only if they meet all of the following criteria:
- Subject must be a female >40 years of age at screening.
- Subject must have reported more than 7 to 8 moderate-to-severe hot flashes per day or 50 to 60 hot flashes per week for at least 30 days prior to the Screening Visit of sufficient severity to cause desire for therapeutic intervention.
- Subject must meet 1 of the following criteria:
- A subject who is not at least 2 years postmenopausal must use adequate nonhormonal contraception (eg, barrier methods such as an intrauterine device, diaphragm, cervical cap, or condom) during study participation.
Key exclusion criteria (16 listed)
- Subject has a history of hypersensitivity or adverse reaction to FP-101 or its excipients
- Subject is a known non-responder to previous SSRI or SNRI treatment for VMS
- Subject has a history of self-injurious behavior.
- Subject has a lifetime history of a clinical diagnosis of major depression or treatment for major depressive disorder.
- Subject has a history of clinical diagnosis of borderline personality disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FP-101Dose 1 | Drug | Arm 1 |
| Placebo ComparatorDose 1 | Drug | Arm 2 |
Primary outcome
The primary efficacy endpoint for the main study is the change in the frequency of moderate-to-severe hot flashes.
Time frame: Baseline to Week 8
3 secondary outcomes
Change in the severity of moderate-to-severe hot flashes.
Time frame: Baseline to Week 8
Change in the severity of moderate-to-severe hot flashes.
Time frame: Baseline to Week 4
Change in the frequency of moderate-to-severe hot flashes.
Time frame: Baseline to Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Raad study director
PMG Research of Charlotte, LLC
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FP-101 in people with Hot Flashes, 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 9 inclusion and 16 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 1 Nov 2018. 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?
The primary efficacy endpoint for the main study is the change in the frequency of moderate-to-severe hot flashes. (time frame: Baseline to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2018; AzTrials last refreshed its copy on 6 Nov 2026.