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Hormone Therapy for Menopause-Related Irritability
Study Summary
This trial is testing whether the neurophysiologic basis of susceptibility to estradiol fluctuations and irritability symptoms in perimenopausal women is due to a change in the way the brain processes information.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have a history of heart or blood vessel diseases.I have experienced unexplained bleeding from my genital area.I have had gallbladder problems in the past.I have Type I diabetes.I am not using any mood-altering drugs, hormone therapies, or herbal supplements.I am receiving treatment for severe psychological symptoms.I have a history of blood clots.I have had migraines with aura recently.My family or I have a history of breast, ovarian, or endometrial cancer.I have liver disease or dysfunction.I am not allergic to Climara® or peanut oil in Prometrium®.I am a healthy woman aged between 45 and 59.I often feel very irritable, more than usual.My menstrual cycles have become irregular, varying by more than 7 days.I have had a tumor that grows in response to estrogen.
- Group 1: Estradiol, Then Placebo
- Group 2: Placebo, Then Estradiol
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Frequently Asked Questions
Are adults of advanced age being considered for inclusion into this investigation?
"To meet the requirements of this trial, applicants must be aged 45 to 59. Additionally, there are 11 studies for those under 18 and 21 trials available for patients over 65 years old."
Has the FDA sanctioned Estradiol Patch, 0.1 mg/24 Hours Weekly Transdermal Film, Extended Release?
"Due to its Phase 4 status, which indicates that this treatment is approved, the safety of Estradiol Patch 0.1 mg/24 Hours Weekly Transdermal Film Extended Release was given a score 3 on our 1-3 scale."
Who has been deemed eligible to participate in this experiment?
"This clinical trial seeks to enrol 50 individuals between the ages of 45-59 who are in the early stages of menopausal transition (as evidenced by irregular menstrual cycles). Other prerequisites include: elevated irritability as measured on IDAS ill-temper scale, a negative mammogram within 12 months, BMI falling between 18 - 45 kg/m^2 and proof that they have experienced 1 or more stressful life events."
How many participants are receiving treatment through this research?
"Affirmative. The details provided on clinicaltrials.gov indicate that, since June 15th 2022, this medical trial has been actively recruiting participants for the study; in total, 50 patients need to be sourced from 1 centre of care."
Is this clinical study presently taking in new participants?
"This research study, which was initially posted on June 15th 2022, is currently recruiting participants. The most recent revision to the trial information occurred on October 4th of this year."
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