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Estrogen Receptor Agonist
Estetrol for Hot Flashes in Menopause
Phase 3
Waitlist Available
Research Sponsored by Estetra
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 baseline, week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
Awards & highlights
Study Summary
This trial is testing a new hormone to treat hot flashes and other menopause symptoms. It is testing how well it works and how safe it is.
Who is the study for?
Postmenopausal women aged 40-65 seeking relief from hot flashes can join this trial. They must be in good health, have a normal mammogram, and if not hysterectomized, have a thin endometrial lining and no abnormal biopsy results. Women with high blood pressure, clotting disorders, severe liver or kidney disease, certain psychiatric conditions or recent drug trials cannot participate.Check my eligibility
What is being tested?
The E4Comfort Study I is testing Estetrol (E4) tablets at two doses against placebo to see how well they reduce the severity and frequency of menopause-related hot flashes. The study has two parts: one for efficacy (how well it works) and another for safety (looking at any potential risks).See study design
What are the potential side effects?
Possible side effects of Estetrol may include typical hormone therapy reactions like nausea, headaches, breast tenderness or swelling. There's also a risk of more serious issues such as blood clots or elevated blood pressure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of endometrial hyperplasia with up to 12 months of treatment based on endometrial biopsies (Endometrial and General Safety Study Part)
Mean change in severity of moderate to severe vasomotor symptoms (VMS) from Baseline to Week 12 (Efficacy Study Part)
Mean change in severity of moderate to severe vasomotor symptoms (VMS) from Baseline to Week 4 (Efficacy Study Part)
+2 moreSecondary outcome measures
Change from Baseline to Week 12 in Homeostasis model-assessment-estimated insulin resistance (HOMA-IR) (Efficacy Study Part)
Change from Baseline to Week 12 in fasting glycaemia (Efficacy Study part)
Change from Baseline to Week 12 in plasma concentration of glycated hemoglobin (Efficacy Study Part)
+78 moreTrial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Estetrol 20 mg -Efficacy PartExperimental Treatment1 Intervention
Estetrol (E4) 20 mg will be administered orally once daily for a minimum of 12 weeks and not longer than 13 weeks
Group II: Estetrol 20 mg + P4 100 mg - Safety PartExperimental Treatment2 Interventions
Estetrol (E4) 20 mg and Progesterone (P4) 100 mg will be administered once daily for up to 53 weeks
Group III: Estetrol 15 mg -Efficacy PartExperimental Treatment1 Intervention
Estetrol (E4) 15 mg will be administered orally once daily for a minimum of 12 weeks and not longer than 13 weeks
Group IV: Placebo - Efficacy PartPlacebo Group1 Intervention
Placebo will be administered orally once daily for a minimum of 12 weeks and not longer than 13 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Estetrol oral tablet
2019
Completed Phase 3
~1020
Find a Location
Who is running the clinical trial?
EstetraLead Sponsor
15 Previous Clinical Trials
73,816 Total Patients Enrolled
ICON Clinical ResearchIndustry Sponsor
49 Previous Clinical Trials
13,802 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have systemic lupus erythematosus.You have a serious mental health condition that requires ongoing treatment.You are experiencing hot flashes or other symptoms related to menopause and are seeking treatment to alleviate them.You had a mammogram done in the last 9 months and it did not show any significant signs of disease.Women who are between 40 and 65 years old at the time of selection.If you have had your uterus removed, it must have been at least 6 weeks before the screening for this study. It doesn't matter if only part of the uterus was removed.You experience hot flashes or night sweats at least once a week at a moderate to severe level.You experience at least one moderate to severe hot flash per week.You have a history of drug or alcohol abuse within the last year as determined by the researcher. This includes marijuana, even if it is legal in your state.You have participated in another clinical trial involving an experimental drug or have taken an experimental drug in the past month.If you are a woman who has not had a hysterectomy, you cannot participate if you have a known allergy to peanuts.You must have a body mass index between 18.0 and 38.0 kg/m².You smoke more than 15 cigarettes per day.You have or had a problem with your gallbladder, unless you have had your gallbladder removed.You have taken phytoestrogens or black cohosh for hot flashes in the last 2 weeks before the screening.You have a history of allergic reactions or intolerance to the investigational drug or drugs similar to it.You experience at least 7 moderate to severe hot flashes or 50 moderate to severe hot flashes per week for the past week.You have read and signed a document that explains the study, and you agree to participate in it.If you haven't had a hysterectomy, the lining of your uterus measured by ultrasound should be less than 4mm.If you still have your uterus, you need to have a biopsy taken during screening to check for any abnormal conditions like cancer, pre-cancerous changes, or abnormal tissue growth. The biopsy must provide enough tissue for a proper diagnosis.Your body weight is within a specific range based on your height, and you are not too underweight or overweight.You are experiencing menopause-related symptoms such as hot flashes, and are seeking treatment to alleviate them.You experience at least 7 significant hot flashes per day or 50 significant hot flashes per week consistently for the past week.You have had cancer before, except for non-serious skin cancers like basal cell or squamous cell carcinoma that were treated more than a year ago.You have unexplained vaginal bleeding or unusual bleeding from your uterus.You have had a procedure called endometrial ablation.
Research Study Groups:
This trial has the following groups:- Group 1: Estetrol 15 mg -Efficacy Part
- Group 2: Estetrol 20 mg -Efficacy Part
- Group 3: Placebo - Efficacy Part
- Group 4: Estetrol 20 mg + P4 100 mg - Safety Part
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Hot Flashes Patient Testimony for trial: Trial Name: NCT04209543 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are investigators actively searching for new participants?
"That is correct. Currently, the clinical trial is looking for 1500 participants from 39 different locations. The information was originally posted on December 30th, 2019 and was last edited on May 9th, 2022."
Answered by AI
Has the Progesterone oral tablet undergone FDA approval?
"Progesterone oral tablet received a safety score of 3 because this medication has cleared multiple rounds of testing with positive results."
Answered by AI
Are there many Progesterone oral tablet clinical trials?
"Progesterone oral tablet was first researched in 1996 at the National Institutes of Health Clinical Center. A total of 265 clinical trials have completed since then, with 46 more active trials currently underway. Many of these studies are based out of Las Vegas, Nevada."
Answered by AI
Are only senior citizens able to participate in this experiment?
"In order for patients to be included in this particular trial, they must fall between the ages of 40-65. There are 11 other trials that cater to those under 18 and 25 additional ones for adults over 65."
Answered by AI
Progesterone is regularly taken to treat which condition?
"Progesterone is frequently used to treat amenorrhea, but it can also help with uterine bleeding, hormonal imbalances, and preventing preterm births."
Answered by AI
Who else is applying?
What state do they live in?
Florida
Texas
Arizona
What site did they apply to?
Noble Clinical Research
Estetra Study Site
Infinite Clinical Trials
Other
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
0
Why did patients apply to this trial?
Was on Premarin previously. Have hot flashes and night sweats and would be willing to travel to be a part of this study.
PatientReceived 1 prior treatment
I would love to find or try to find any relief for hot flashes and night sweats. I am tired of waking up or just ending up fully drenched in sweat.
PatientReceived 2+ prior treatments
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