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Hormone Therapy

Hormone Therapy for Menopause-Related Irritability

Phase 4
Recruiting
Led By Elizabeth Andersen, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy women 45 - 59 years of age
Moderate to severe irritability symptoms, as defined by IDAS ill-temper scale score >10
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 13
Awards & highlights

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.

Who is the study for?
This trial is for healthy women aged 45-59 in early menopause with variable menstrual cycles, increased irritability, and a BMI of 18-45. They must have had a stressful event recently and no history of heart disease, certain cancers, liver disease, severe hypertension, or mental health conditions requiring treatment.Check my eligibility
What is being tested?
The study tests if an Estradiol Patch (hormone therapy) can stabilize mood changes related to estrogen fluctuations during perimenopause. Women will be randomly given either the hormone patch or a placebo along with Progesterone to see how it affects irritability.See study design
What are the potential side effects?
Possible side effects include skin irritation at the patch site, headaches, breast tenderness or pain, abdominal cramps or bloating. There's also a risk of more serious issues like blood clots due to hormonal changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a healthy woman aged between 45 and 59.
Select...
I often feel very irritable, more than usual.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 13
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 13 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean IDAS Ill Temper Scale Score Over Time
Secondary outcome measures
Beta Oscillatory Activity (13-30 Hz) In Response To Affective Posner Paradigm (probing Frustration) Over Time
Theta Oscillatory Activity (4-8 Hz) In Response To Dot Probe Task (Indexing Threat) Over Time

Trial Design

2Treatment groups
Experimental Treatment
Group I: Placebo, Then EstradiolExperimental Treatment3 Interventions
Participants will first receive transdermal placebo patch (matching transdermal estradiol 0.1 mg/day patch) for 3 weeks. After a washout period of 3 weeks, participants will then receive 0.1 mg/day of transdermal estradiol patch for 3 weeks. Upon completion of the second intervention, all participants will receive 200 mg/day of progesterone for 10 days.
Group II: Estradiol, Then PlaceboExperimental Treatment3 Interventions
Participants will first receive 0.1 mg/day of transdermal estradiol patch for 3 weeks. After a washout period of 3 weeks, participants will then receive transdermal placebo patch (matching transdermal estradiol 0.1 mg/day patch) for 3 weeks. Upon completion of the second intervention, all participants will receive 200 mg/day of progesterone for 10 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,500 Previous Clinical Trials
4,176,668 Total Patients Enrolled
2 Trials studying Menopause
202 Patients Enrolled for Menopause
National Institute of Mental Health (NIMH)NIH
2,775 Previous Clinical Trials
2,673,694 Total Patients Enrolled
4 Trials studying Menopause
344 Patients Enrolled for Menopause
Elizabeth Andersen, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
2 Previous Clinical Trials
113 Total Patients Enrolled

Media Library

Estradiol Patch, 0.1 mg/24 Hours Weekly Transdermal Film, Extended Release (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05388656 — Phase 4
Menopause Research Study Groups: Estradiol, Then Placebo, Placebo, Then Estradiol
Menopause Clinical Trial 2023: Estradiol Patch, 0.1 mg/24 Hours Weekly Transdermal Film, Extended Release Highlights & Side Effects. Trial Name: NCT05388656 — Phase 4
Estradiol Patch, 0.1 mg/24 Hours Weekly Transdermal Film, Extended Release (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05388656 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~14 spots leftby Dec 2024