Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05388656
Other study ID # 21-3395
Secondary ID R21MH128241
Status Recruiting
Phase Phase 4
First received
Last updated
Start date June 15, 2022
Est. completion date December 2024

Study information

Verified date October 2023
Source University of North Carolina, Chapel Hill
Contact Kayla Jensen
Phone (919) 445-6815
Email uncwisestudy@unc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Women in the menopause transition (perimenopause) experience substantial day-to-day variability in estradiol and have a 2-4-fold increase in major depression risk. About 40% of perimenopausal women are susceptible to the emergence of affective symptoms tied to changes in estradiol. Among the perimenopausal women with affective impairment, most report irritability, not "depression," is their primary source of impairment and distress. The purpose of this research is to determine the neurophysiologic basis of susceptibility to estradiol fluctuations and irritability symptoms in perimenopausal women.


Description:

Using a within-subjects, cross-over design and transdermal estradiol to stabilize estradiol fluctuations (and increase levels) the investigators will test if neural dynamics (oscillatory activity in the theta and beta frequencies assessed via EEG) associated with key constructs of irritability (attentional bias to threat and frustration to non-reward) represent a biomarker target of irritability symptom response to transdermal estradiol.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 45 Years to 59 Years
Eligibility Inclusion Criteria: - Healthy women 45 - 59 years of age - In the early menopause transition (defined by variable menstrual cycle length that is 7+ days longer or shorter than usual) - Increase in irritability since the onset of menstrual cycle changes - Moderate to severe irritability symptoms, as defined by IDAS ill-temper scale score >10 - Have experienced 1+ very stressful life event (e.g. divorce, death of family member) within the past 6 months - Negative mammogram within the past two years - BMI between 18 - 45 kg/m^2 Exclusion Criteria: - Use of psychotropic agents or hormonal preparations, or herbal supplements (other than multivitamins) believed to affect mood or menopausal symptoms - History of psychosis, bipolar disorder, or substance dependence - Active psychological symptoms severe enough to require treatment - Current suicidal intent or recent history of suicide attempts (within past 10 years) - Personal or family history of cancer indicative of more than average risk for breast, ovarian or endometrial cancers - Personal history of any cardiovascular disease including coronary artery disease, arteriosclerosis, heart attack, stroke - Personal history of thromboembolic disorders - History of E2-dependent neoplasia - History of gallbladder disease - Recent history of migraine with aura - Blood pressure classified as higher than stage 2 hypertension (=160 mmHg systolic or =100 mmHg diastolic) - Liver dysfunction or disease - Undiagnosed abnormal genital bleeding - Type I diabetes - Known sensitivities to the matrix patch system in Climara® or allergy to peanut oil used in Prometrium®

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Estradiol Patch, 0.1 mg/24 Hours Weekly Transdermal Film, Extended Release
0.1 mg/day transdermal patch administered for 3 weeks
Placebo
Estradiol-matched placebo patch administered for 3 weeks
Progesterone 200 mg
200 mg tablet administered by mouth once per day for 10 days after completion of the experimental phase of the study

Locations

Country Name City State
United States Carolina Crossing B, Suite 1 Chapel Hill North Carolina

Sponsors (2)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean IDAS Ill Temper Scale Score Over Time The 5-item ill temper scale of the Inventory of Depression and Anxiety Symptoms (IDAS) will be the primary measure of irritability symptom severity. Each symptom item is rated 1 (not at all) to 5 (extremely). The total IDAS ill temper scale score may range from 5-25. Higher scores indicate more severe irritability symptoms. The average daily irritability (IDAS) score over 1 week (7 days) will be assessed at baseline (Week 4), the last week of Condition 1 (Week 7), and the last week of Condition 2 (Week 13). up to Week 13
Secondary Theta Oscillatory Activity (4-8 Hz) In Response To Dot Probe Task (Indexing Threat) Over Time Participants will complete the Dot Probe Task while EEG is recorded to examine brain responses (theta oscillations) to threat. During the task, participants will be presented with a pair of faces on each side of the screen. In anger trials, one face is angry and the other is neutral. The pair of faces is followed by an asterisk, half of the time presented on the same side as the angry face and half of the time presented on the side of the neutral face. Trials will be angry-neutral, happy-neutral, and neutral-neutral. Theta recorded at the frontal midline electrode during the different task conditions will be assessed at baseline (Week 4), Condition 1 (Week 7), and Condition 2 (Week 13). up to Week 13
Secondary Beta Oscillatory Activity (13-30 Hz) In Response To Affective Posner Paradigm (probing Frustration) Over Time Participants will complete the Affective Posner Paradigm while EEG is recorded to examine brain activity (beta oscillations) during frustrating task events. The Affective Posner Paradigm is a reward task designed to measure frustration to non-reward, consisting of three runs with varying degrees of reward as the participant performs the task. Beta oscillatory activity during the three task conditions will be assessed at baseline (Week 4), Condition 1 (Week 7), and Condition 2 (Week 13). up to Week 13
See also
  Status Clinical Trial Phase
Completed NCT04553029 - A Survey Evaluating Prevalence, Severity and Associated Factors in East Asian Women With Moderate-to-severe Menopause-related Vasomotor Symptoms (MR-VMS)
Completed NCT03672513 - Short-term Supplementation, Bone Turnover and Antioxidant Status in Menopause N/A
Terminated NCT03642119 - Validation of an Objective Instrument to Measure Hot Flashes During Menopause
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Completed NCT04210583 - RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity N/A
Completed NCT06057896 - Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
Completed NCT05617287 - An Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Perimenopause and Menopause N/A
Recruiting NCT05180266 - Therapeutic Touch and Music in The Menopausal Period N/A
Recruiting NCT04043520 - Bioenergetic Effects of Aging and Menopause (BEAM) Phase 4
Completed NCT03663075 - Effect of Group Education and Individual Counselling on Mental Health and Quality of Life in 45-60 Year Old Women N/A
Completed NCT03363997 - Pharmacokinetics and Pharmacodynamics of 3 Dosages of Estriol After Continuous Vaginal Administration for 21 Days Phase 1
Not yet recruiting NCT04728126 - Menopausal Symptoms and Burnout: Comparison of Occupational Health Issue Among Health Professionals in UMC Hospitals
Not yet recruiting NCT04724135 - Assessment of Menopause Related Quality of Life Among Health Professionals in University Hospitals of UMC in Nur-Sultan
Completed NCT02274571 - Raising Insulin Sensitivity in Post Menopause Early Phase 1
Completed NCT02430987 - Low Sexual Desire and Metabolic Syndrome N/A
Completed NCT02253173 - Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women Phase 3
Completed NCT01757340 - Calorie Restriction With Leucine Supplementation N/A
Recruiting NCT01488903 - A Cohort Research of Genetic Susceptibility for Common Obesity in Women N/A
Terminated NCT01633814 - Hormone Replacement and Neural Cardiovascular Control in Postmenopausal Women N/A
Completed NCT00599456 - Investigation of the Usefulness of Omega 3 Vitamins in the Relief of Hot Flashes in Menopausal Women. N/A