Study Summary
This trial will study the effects of a hormone on brain function in women experiencing early menopause symptoms.
- Psychosis
- Anhedonia
- Depression
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: Baseline (week 3) to Endpoint (week 7)
Trial Safety
Safety Progress
Side Effects for
Trial Design
8 Treatment Groups
Perimenopausal women with high anhedonia + moderate psychosis, placebo group
1 of 8
Perimenopausal women with mild-to-moderate anhedonia + moderate psychosis, place...
1 of 8
Perimenopausal women with high anhedonia + absent-to-mild psychosis, placebo gro...
1 of 8
Perimenopausal women with high anhedonia + moderate psychosis, active group
1 of 8
Perimenopausal women with mild-to-moderate anhedonia + absent-to-mild psychosis,...
1 of 8
Perimenopausal women with mild-to-moderate anhedonia + moderate psychosis, activ...
1 of 8
Perimenopausal women with mild-to-moderate anhedonia + absent-to-mild psychosis,...
1 of 8
Perimenopausal women with high anhedonia + absent-to-mild psychosis, active grou...
1 of 8
Experimental Treatment
103 Total Participants · 8 Treatment Groups
Primary Treatment: Transdermal Estradiol · Has Placebo Group · Phase 4
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 45 - 55 · Female Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Bromberger, Joyce T., Karen A Matthews, Laura L. Schott, Sarah Brockwell, Nancy E. Avis, Howard M. Kravitz, Susan A. Everson-Rose, Ellen B. Gold, MaryFran Sowers, and John F. Randolph Jr.. 2007. “Depressive Symptoms During the Menopausal Transition: The Study of Women's Health Across the Nation (SWAN)”. Journal of Affective Disorders. Elsevier BV. doi:10.1016/j.jad.2007.01.034.
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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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor