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FP-101 for the Treatment of Hot Flashes in Postmenopausal Women

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ClinicalTrials.gov Identifier: NCT03285672
Recruitment Status : Completed
First Posted : September 18, 2017
Last Update Posted : November 1, 2018
Sponsor:
Collaborator:
Iqvia Pty Ltd
Information provided by (Responsible Party):
Fervent Pharmaceuticals

Brief 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.

Condition or disease Intervention/treatment Phase
Hot Flashes Drug: FP-101 Drug: Placebo Comparator Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : March 26, 2018
Actual Primary Completion Date : October 29, 2018
Actual Study Completion Date : October 29, 2018

Arm Intervention/treatment
Experimental: Arm 1
FP-101
Drug: FP-101
Dose 1

Placebo Comparator: Arm 2
Placebo Comparator
Drug: Placebo Comparator
Dose 1




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Change in the severity of moderate-to-severe hot flashes. [ Time Frame: Baseline to Week 8 ]
  2. Change in the severity of moderate-to-severe hot flashes. [ Time Frame: Baseline to Week 4 ]
  3. Change in the frequency of moderate-to-severe hot flashes. [ Time Frame: Baseline to Week 4 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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).
    • 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.

Exclusion Criteria:

  • 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).
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03285672


Locations
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United States, Illinois
PMG Research of Christie Clinic, LLC
Champaign, Illinois, United States, 61820
United States, North Carolina
PMG Research of Cary, LLC
Cary, North Carolina, United States, 27518
PMG Research of Charlotte, LLC
Charlotte, North Carolina, United States, 28209
PMG Research of Hickory, LLC
Hickory, North Carolina, United States, 28601
PMG Research of Raleigh, LLC
Raleigh, North Carolina, United States, 27609
Nash OB/GYN
Rocky Mount, North Carolina, United States, 27804
PMG Research of Salisbury, LLC
Salisbury, North Carolina, United States, 28144
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States, 28401
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, United States, 27103
United States, South Carolina
PMG Research of Charleston, LLC
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
PMG Research of Bristol, LLC
Bristol, Tennessee, United States, 37620
PMG Research of Knoxville
Oak Ridge, Tennessee, United States, 37830
Sponsors and Collaborators
Fervent Pharmaceuticals
Iqvia Pty Ltd
Investigators
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Study Director: George Raad PMG Research of Charlotte, LLC
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Responsible Party: Fervent Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03285672    
Other Study ID Numbers: FERV001
First Posted: September 18, 2017    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fervent Pharmaceuticals:
Hot Flashes, vasomotor symptoms, postmenopausal
Additional relevant MeSH terms:
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Hot Flashes