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Transdermal Estradiol for Mental Illness (PEEPS Trial)
PEEPS Trial Summary
This trial will study the effects of a hormone on brain function in women experiencing early menopause symptoms.
PEEPS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPEEPS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2015 Phase 4 trial • 65 Patients • NCT00030147PEEPS Trial Design
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Who is running the clinical trial?
Media Library
- My parent, sibling, or child has had ovarian cancer.You have experienced a loss of interest or pleasure, or symptoms of being out of touch with reality, during a time when your menstrual cycle was not regular.Your doctor has rated your overall mental health as moderately to severely impaired.I am currently taking medication for my mental health or hormones.A close family member had breast cancer early or in both breasts, or more than three relatives had it after menopause.I am a woman aged 44-55, in late menopause transition, with irregular periods.I have a condition affecting my gallbladder or pancreas.I have had depression in the last 2 years not due to menopause.I have a history of seizures or traumatic brain injury.You are pregnant or allergic to any ingredients in the Climara® patch or Prometrium®.You have tried to harm yourself in the past year or are currently thinking about hurting yourself with a plan to do so.You have anhedonia, a condition where you can't feel pleasure, and your SHAPS score is over 20, which shows that it's causing problems in your daily life.I have been diagnosed with polycystic ovary syndrome.I have not had a menstrual period in over a year.A close family member has had a heart attack or stroke.A doctor has reviewed and approved all my prescription medications for this study.I experience migraines with aura.I carry a BRCA1 or BRCA2 gene mutation.Your ovaries are larger than normal, and the cause is not known.I have had a stroke.I have heart or kidney disease.You are allergic to peanuts.I am currently taking medication for mental health, blood pressure, cholesterol, hormones, or inflammation.I have a liver condition.You have metal or implants in your body that could interfere with a magnetic resonance imaging (MRI) scan.I have been diagnosed with endometriosis.I have been diagnosed with malignant melanoma.I have had multiple mood or psychotic episodes not related to reproductive cycles.I have experienced vaginal bleeding without a known cause.My doctor found something unusual in my breast exam or mammogram.I have not had brain stimulation treatment in the last 6 months.You have had a mental health condition in the 2 years before entering perimenopause.I am currently experiencing a manic episode.You have been hospitalized for mood swings in the past.I have had irregular periods for more than a year.I have been diagnosed with Hodgkin's disease.My BMI is either below 18 or above 35.You currently use nicotine.I am claustrophobic.I have had breast or ovarian cancer in the past.I have porphyria.I am willing and able to follow all study rules and attend all appointments.My psychosis severity is categorized based on my BPRS score.
- Group 1: Perimenopausal women with high anhedonia + moderate psychosis, placebo group
- Group 2: Perimenopausal women with mild-to-moderate anhedonia + moderate psychosis, placebo group
- Group 3: Perimenopausal women with high anhedonia + absent-to-mild psychosis, placebo group
- Group 4: Perimenopausal women with high anhedonia + moderate psychosis, active group
- Group 5: Perimenopausal women with mild-to-moderate anhedonia + absent-to-mild psychosis, placebo group
- Group 6: Perimenopausal women with mild-to-moderate anhedonia + moderate psychosis, active group
- Group 7: Perimenopausal women with mild-to-moderate anhedonia + absent-to-mild psychosis, active group
- Group 8: Perimenopausal women with high anhedonia + absent-to-mild psychosis, active group
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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
Am I able to participate in this clinical trial?
"This medical trial is accepting 103 individuals aged 44-55 who suffer from anhedonia. To be eligible for the study, applicants must provide a signed consent form and agree to adhere to all procedures outlined by the researchers. Additionally, participants should have missed at least two menstrual cycles within 60 days as well as present with clinically impairing levels of pleasure according to SHAPS scores and symptoms associated with psychosis based on BPRS testing. Lastly, they must also commit to adhering strictly to the estradiol regimen prescribed throughout the duration of this clinical project."
Does the research team welcome participants who are septuagenarian or older?
"The minimum and maximum age for enrollment in this trial as stipulated by the inclusion criteria are 44 years old and 55 years old, respectively."
Has the Federal Drug Administration authorized Transdermal Estradiol?
"Transdermal Estradiol has been approved, so its safety rating was given a 3 out of 3 by Power."
What is the current enrollment size of this research project?
"Affirmative. Clinicaltrials.gov's information reveals that this trial, which was initially announced on April 1st 2022, is currently in the process of recruitment. Around 103 participants need to be enrolled from one medical site."
Are there still openings for participants in this experiment?
"According to clinicaltrials.gov, this research endeavour is still searching for participants who meet the eligibility criteria. The trial was initially published on April 1st 2022 and underwent a revision as recently as April 21st 2022."
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