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Selective Estrogen Receptor Modulator
FP-101 Versus Placebo in the Treatment of Menopausal Vasomotor Symptoms
Phase 2
Waitlist Available
Research Sponsored by Fervent Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up recorded every 12 hrs over a 1-week treatment period.
Summary
This trial tests a slow-release pill called FP-101 to help women over 45 who suffer from severe hot flashes during menopause. The pill aims to reduce the frequency and severity of these hot flashes by releasing its medicine gradually.
Eligible Conditions
- Hot Flashes
- Menopause
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ recorded every 12 hrs over a 1-week treatment period.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~recorded every 12 hrs over a 1-week treatment period.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in the frequency (average daily number) of moderate-to-severe hot flashes.
Secondary study objectives
Change in nighttime awakenings (average daily number) with or without night sweats.
Hot flushes
Therapeutic procedure
Other study objectives
Any Adverse Events and Concomitant Medications
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active Treatment (FP-101)Experimental Treatment1 Intervention
White to off-white extended-release, round tablets containing FP-101.
Group II: Matching placeboPlacebo Group1 Intervention
White to off-white round tablets without the active ingredient but otherwise matching in size and appearance.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FP-101
2018
Completed Phase 2
~220
Find a Location
Who is running the clinical trial?
Fervent PharmaceuticalsLead Sponsor
1 Previous Clinical Trials
109 Total Patients Enrolled
1 Trials studying Hot Flashes
109 Patients Enrolled for Hot Flashes
ICON plcIndustry Sponsor
87 Previous Clinical Trials
28,776 Total Patients Enrolled
Helmut H Albrecht, MDStudy DirectorLumanity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You must avoid using certain cough and cold medications that have the same ingredients as the study drug.You cannot take certain over-the-counter cough and cold medications during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Active Treatment (FP-101)
- Group 2: Matching placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.