Cyclic vs. Constant Estradiol: Regimens' Effects on Brain Health

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT07831499
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
38 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Cyclic Estradiol — DRUG
    Participants randomized to the cyclic estradiol group apply a transdermal estradiol patch delivering 100 mcg/day for 5 days every 21 days over approximately 12 weeks. The patch is removed on the fifth day of each treatment cycle. The final patch is worn for 7 days.
  • Continuous Estradiol — DRUG
    Participants randomized to the continuous estradiol group apply a transdermal estradiol patch delivering 100 mcg/day continuously for approximately 12 weeks. The patch is replaced every 6 days and worn throughout the treatment period. The final patch is worn for 7 days.

Study Details

The purpose of this study is to learn more about how estradiol patch treatment affects brain processes, health, and wellbeing.

Key Dates

First listed
Sep 21, 2026
Start date
Jul 15, 2026
Status verified
Sep 2026
Primary completion
Jul 15, 2028
Completion
Jul 15, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Cyclic Estradiol
    Transdermal estradiol 100 mcg/day patch applied for 5 days every 21 days for approximately 12 weeks.
  • Experimental: Continuous Estradiol
    Transdermal estradiol 100 mcg/day patch worn continuously and replaced every 6 days for approximately 12 weeks.

Primary Outcome Measure

Change in Dorsolateral Prefrontal Cortex (dlPFC) activation during working memory task in women receiving either cyclic or continuous estradiol administration. [ Time Frame: Baseline and approximately 12 weeks after initiation of study treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado AnschutzAuroraColorado80045
Research Services Professional
[email protected]
‪720-281-9282‬
Neill Epperson, MD (PRINCIPAL_INVESTIGATOR)

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