Early Menopause Hormone Treatment and Cognition

NCT01046643 | Completed Results DMC

• 1 other identifier: 1R21AG031951-01A1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the neurobiological effects of hormone therapy (HT) in healthy early postmenopausal women. The studies proposed in this project seek to define the association between different hormone forms (estradiol only and progesterone only) versus placebo on brain functional measures. The functional measures will include the performance of the volunteers on a comprehensive neuropsychological testing battery, and the brain functional responses to episodic memory (verbal and non-verbal) challenges as well as emotional processing determined with functional magnetic resonance imaging (fMRI).

Conditions

Menopausal Syndrome

Keywords

Women; Healthy; Menopausal; Hormone treatment

Outcome Measures

Primary Outcomes (2)

• Changes in Brain Activation Patterns in Verbal Tasks Determined With the Functional Magnetic Resonance Imaging (fMRI) Scans

  Measure the changes in brain activity in verbal tasks with hormone use (either estradiol or progesterone) versus placebo. The test is a deep and shallow verbal processing task, where the subjects are presented lists of words, one word at a time, and are asked to make one of 2 decisions about each list. One decision is whether each word is written in upper or lower case letters (shallow processing), and the other decision is whether each word denotes an abstract or concrete concept (deep processing). The test was administered 3 months after baseline and 38 weeks after baseline.

  August 2010 - March 2012

• Changes in Brain Activation Patterns in Visual Tasks Determined With the Functional Magnetic Resonance Imaging (fMRI) Scans

  Measure the changes in brain activity in visual tasks with hormone use (either estradiol or progesterone) versus placebo. The test is a visual working memory task, where the women are presented with 3 geometric grids on the screen. The target grid is on top, and 2 test grids are on the bottom. The women must decide if the right or left test grid matches the grid on top. There are 3 conditions: a match condition where all 3 grids are shown simultaneously, and 2 delay conditions, where the target grid is shown first, disappears, and the test grids appear after a 1 or a 4 second delay. The test was administered 3 months after baseline and 38 weeks after baseline.

  August 2010 - March 2012

Secondary Outcomes (2)

• Neuropsychological Testing Scores - Verbal Learning Retention

  August 2010 - March 2012

• Neuropsychological Testing Scores - Visual Learning Retention

  August 2010 - March 2012

Study Arms (4)

Estrogen followed by Placebo

ACTIVE COMPARATOR

Estrogen treatment with Estradiol (E2) followed by Placebo.

Drug: Estradiol (E2); Drug: Progesterone (P10) x10

Progesterone followed by Placebo

ACTIVE COMPARATOR

Progesterone (P10) treatment followed by Placebo.

Drug: Progesterone (P10) x90

Placebo followed by Estrogen

ACTIVE COMPARATOR

Placebo followed by Estrogen treatment with Estradiol (E2)

Drug: Estradiol (E2); Drug: Progesterone (P10) x10

Placebo followed by Progesterone

ACTIVE COMPARATOR

Placebo followed by Progesterone (P10) treatment.

Drug: Progesterone (P10) x90

Interventions

Estradiol (E2) DRUG

One Estradiol capsule (1mg) once a day, at the same time each day, for 90 days; followed by one Progesterone (200mg) once a day, at the same time each day, for 10 days to slough endometrial lining; followed by one Placebo capsule once a day, at the same time each day, for 90 days.

Also known as: E2

Estrogen followed by Placebo; Placebo followed by Estrogen

Progesterone (P10) x90 DRUG

One Progesterone capsule (200mg) once a day, at the same time each day, for 90 days; followed by one Placebo capsule (to mirror Progesterone capsule to slough endometrial lining in Estradiol recipients) once a day, at the same time each day, for 10 days ; followed by one Placebo capsule once a day, at the same time each day, for 90 days.

Also known as: P10

Placebo followed by Progesterone; Progesterone followed by Placebo

Progesterone (P10) x10 DRUG

One Progesterone (200mg) capsule once a day for 10 days, to slough endometrial lining for patients taking Estradiol. Patients taking Progesterone will take an equivalent Placebo capsule during this time period.

Also known as: P10

Estrogen followed by Placebo; Placebo followed by Estrogen

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Postmenopausal women
• Ages 45-55, 6 - 36 months from their last menstrual period.

You may not qualify if:

• Left handedness
• Acute medical illness
• Neurologic illness
• Psychiatric illness
• Heart disease
• Thromboembolic disease
• Liver disease
• Uncorrected thyroid disease
• Diabetes
• Neurological disease
• Porphyria
• Allergy to estradiol
• Progesterone or lactose
• Lactose intolerance
• Claustrophobia

Sponsors & Collaborators

• University of Michigan: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Interventions

Estradiol; Progesterone; Annexin A2

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnenediones; Pregnenes; Pregnanes; Corpus Luteum Hormones; Progesterone Congeners; Annexins; Calcium-Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Yolanda Smith
• Organization: The University of Michigan

ysmith@med.umich.edu

(734) 936-7401

Study Officials

• Yolanda R. Smith, M.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 11, 2010
• First Posted: January 12, 2010
• Study Start: May 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: May 19, 2014
• Results First Posted: May 19, 2014

Record last verified: 2014-05

Locations

US (1)