Estrogen Modulation for Menopause Mood and Cognition

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Center for Research Resources (NCRR)

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study will examine whether estrogen administration in postmenopausal women can alter the response to changes in brain chemistry brought about by dietary manipulation. Women who are recently menopausal (50-60 yrs. of age) and over 20 years postmenopausal (\>70 yrs. of age) will take estrogen or placebo for three months. At the end of that time they will participate in three challenges using dietary techniques to briefly change the relative amounts of neurotransmitters in the brain that are believed to be related to mood regulation (serotonin, dopamine, and norepinephrine). Previous research has shown that these dietary manipulations can briefly produce negative changes in mood. The investigator hypothesizes that estrogen administration will blunt or buffer these negative effects in a quantifiable way. The investigator believes that this will provide a direct test of the ability of estrogen to meaningfully change the brain chemistry of mood in a clinically measurable and positive way. The proposed procedure will also allow assessment of the effects of estrogen on brain neurotransmitter systems after many years of very low estrogen levels.

Eligibility Criteria

This trial is for healthy, non-smoking postmenopausal women aged 50-60 and those over 70. Participants must have a BMI under 30, not be on hormone replacement therapy (HRT) or more than a year past HRT, have had a normal mammogram in the last year, and cannot have surgically-induced menopause or cardiovascular disease.

Inclusion Criteria

Non-smoker

BMI <30

Healthy

See 5 more

Treatment Details

Interventions

Estrogen (Hormone Therapy)
Placebo ()

Trial OverviewThe study tests if estrogen can affect mood and brain chemistry changes caused by diet in postmenopausal women. Women will take either estrogen or placebo for three months before undergoing dietary challenges to alter neurotransmitters like serotonin.

Estrogen is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as estradiol for:

Vasomotor symptoms of vulvar and vaginal atrophy in menopause
Hypoestrogenism
Prevention of postmenopausal osteoporosis
Treatment of breast cancer
Advanced androgen-dependent carcinoma of the prostate

🇪🇺 Approved in European Union as estradiol for:

Hormone replacement therapy for oestrogen deficiency symptoms in postmenopausal women
Prevention of osteoporosis in postmenopausal women at high risk of future fractures

🇨🇦 Approved in Canada as estradiol for: