Vascular Mechanisms for the Effects of Loss of Ovarian Ho... | NCT02122198

ID	Type	Description	Link
UL1TR001082	U.S. NIH Grant/Contract		View source

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Monthly placebo injections for 6 months under parent study (FAME) protocol (NCT01712230)	Drug: Placebo
GnRH agonist	Active Comparator	Monthly injections of leuprolide acetate 3.75mg for 9 months; first 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study protocol. Weekly application of estradiol patch 0.075mg/d months 6-9. Daily medroxyprogesterone acetate 5mg by mouth for 12 days at week 30.	Drug: Leuprolide acetate Drug: Estradiol Drug: Medroxyprogesterone

Name	Type	Description	Arm Group Labels	Other Names
Leuprolide acetate	Drug	Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 9 months. First 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study.

Measure	Description	Time Frame
Changes in Prefrontal Cortex Brain Activation at 6 Months	Changes in patterns of brain activation in the prefrontal cortex using functional magnetic resonance imaging (fMRI) during a task of working memory will be measured at baseline, 6 months, and 9 months (GnRH agonist arm only). Beta weight is the percent signal change on the FMRI from one condition to another. The FMRI is measuring blood oxygen levels and blood flow in different regions of the brain and using that to determine activity changes in the brain. A positive number/increase indicates more blood flow and brain activity in that area.	Baseline, 6 months
Changes in Prefrontal Cortex Brain Activation at 9 Months	Changes in patterns of brain activation in the prefrontal cortex using functional magnetic resonance imaging (fMRI) during a task of working memory will be measured at baseline, 6 months, and 9 months (GnRH agonist arm only). Beta weight is the percent signal change on the FMRI from one condition to another. The FMRI is measuring blood oxygen levels and blood flow in different regions of the brain and using that to determine activity changes in the brain. A positive number/increase indicates more blood flow and brain activity in that area.	Baseline, 9 months

Measure	Description	Time Frame
Changes in Endothelial Function at 6 Months	Changes in endothelial function will be measured using brachial artery flow-mediated dilation at baseline, 6 months	Baseline, 6 months
Changes in Endothelial Function at 9 Months

Name	Affiliation	Role
Kerry L Hildreth, MD	University of Colorado, Denver	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Colorado Anschutz Medical Campus		Aurora	Colorado	80045	United States
University of Colorado Boulder Intermountain Neuroimaging Consortium

ID	Title	Description
FG000	Placebo	Monthly placebo injections for 6 months under parent study (FAME) protocol (NCT01712230) Placebo: placebo
FG001	GnRH Agonist	Monthly injections of leuprolide acetate 3.75mg for 9 months; first 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study protocol. Weekly application of estradiol patch 0.075mg/d months 6-9. Daily medroxyprogesterone acetate 5mg by mouth for 12 days at week 30. Leuprolide acetate: Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 9 months. First 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study. Estradiol: Climara transdermal patch 0.075mg/day applied weekly months 6-9 Medroxyprogesterone: Provera 5mg tablets once daily by mouth for 12 days beginning at week 30.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Apr 12, 2017

ID	Title	Description
BG000	Placebo	Monthly placebo injections for 6 months under parent study (FAME) protocol (NCT01712230) Placebo: placebo
BG001	GnRH Agonist	Monthly injections of leuprolide acetate 3.75mg for 9 months; first 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study protocol. Weekly application of estradiol patch 0.075mg/d months 6-9. Daily medroxyprogesterone acetate 5mg by mouth for 12 days at week 30. Leuprolide acetate: Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 9 months. First 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study. Estradiol: Climara transdermal patch 0.075mg/day applied weekly months 6-9 Medroxyprogesterone: Provera 5mg tablets once daily by mouth for 12 days beginning at week 30.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG0005 BG00112 BG00217

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Changes in Prefrontal Cortex Brain Activation at 6 Months

Changes in patterns of brain activation in the prefrontal cortex using functional magnetic resonance imaging (fMRI) during a task of working memory will be measured at baseline, 6 months, and 9 months (GnRH agonist arm only). Beta weight is the percent signal change on the FMRI from one condition to another. The FMRI is measuring blood oxygen levels and blood flow in different regions of the brain and using that to determine activity changes in the brain. A positive number/increase indicates more blood flow and brain activity in that area.

Posted

Mean

Standard Deviation

beta-weight

Baseline, 6 months

ID	Title	Description
OG000	Placebo	Monthly placebo injections for 6 months under parent study (FAME) protocol (NCT01712230) Placebo: placebo
OG001	GnRH Agonist	Monthly injections of leuprolide acetate 3.75mg for 9 months; first 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study protocol. Weekly application of estradiol patch 0.075mg/d months 6-9. Daily medroxyprogesterone acetate 5mg by mouth for 12 days at week 30. Leuprolide acetate: Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 9 months. First 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study. Estradiol: Climara transdermal patch 0.075mg/day applied weekly months 6-9 Medroxyprogesterone: Provera 5mg tablets once daily by mouth for 12 days beginning at week 30.

Units	Counts
Participants	OG0002 OG0017

Title

Denominators

Categories

Frontal Pole (L)

Title	Measurements
	OG00090.64± 3.88 OG001-62.20± 57.61

Frontal Orbital Cortex (L)

Title	Measurements
	OG000

Primary

Changes in Prefrontal Cortex Brain Activation at 9 Months

This outcome measure was only collected for a subset of the GnRH Agonist group.

Posted

Mean

Standard Deviation

beta-weight

Baseline, 9 months

ID	Title	Description
OG000	GnRH Agonist	Monthly injections of leuprolide acetate 3.75mg for 9 months; first 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study protocol. Weekly application of estradiol patch 0.075mg/d months 6-9. Daily medroxyprogesterone acetate 5mg by mouth for 12 days at week 30. Leuprolide acetate: Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 9 months. First 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study. Estradiol: Climara transdermal patch 0.075mg/day applied weekly months 6-9 Medroxyprogesterone: Provera 5mg tablets once daily by mouth for 12 days beginning at week 30.

Secondary

Changes in Endothelial Function at 6 Months

Changes in endothelial function will be measured using brachial artery flow-mediated dilation at baseline, 6 months

This outcome cannot be reported due to corruption of the collected image data.

Posted

Baseline, 6 months

ID	Title	Description
OG000	Placebo	Monthly placebo injections for 6 months under parent study (FAME) protocol (NCT01712230) Placebo: placebo
OG001	GnRH Agonist	Monthly injections of leuprolide acetate 3.75mg for 9 months; first 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study protocol. Weekly application of estradiol patch 0.075mg/d months 6-9. Daily medroxyprogesterone acetate 5mg by mouth for 12 days at week 30. Leuprolide acetate: Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 9 months. First 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study. Estradiol: Climara transdermal patch 0.075mg/day applied weekly months 6-9 Medroxyprogesterone: Provera 5mg tablets once daily by mouth for 12 days beginning at week 30.

Units	Counts
Participants

Secondary

Changes in Endothelial Function at 9 Months

Changes in endothelial function will be measured using brachial artery flow-mediated dilation at baseline, 9 months

Outcome measure was collected for a subset of the GnRH agonist arm only. This outcome cannot be reported due to corruption of the collected image data.

Posted

Baseline, 9 months

ID	Title	Description
OG000	GnRH Agonist	Monthly injections of leuprolide acetate 3.75mg for 9 months; first 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study protocol. Weekly application of estradiol patch 0.075mg/d months 6-9. Daily medroxyprogesterone acetate 5mg by mouth for 12 days at week 30. Leuprolide acetate: Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 9 months. First 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study. Estradiol: Climara transdermal patch 0.075mg/day applied weekly months 6-9 Medroxyprogesterone: Provera 5mg tablets once daily by mouth for 12 days beginning at week 30.

Units	Counts
Participants	OG000

Secondary

Changes in Artery Compliance at 6 Months

Changes in carotid artery compliance will be measured using ultrasound in at baseline, 6 months.

Posted

Mean

Standard Deviation

mm^2/mmhgx10^-1

Baseline, 6 months

ID	Title	Description
OG000	Placebo	Monthly placebo injections for 6 months under parent study (FAME) protocol (NCT01712230) Placebo: placebo
OG001	GnRH Agonist	Monthly injections of leuprolide acetate 3.75mg for 9 months; first 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study protocol. Weekly application of estradiol patch 0.075mg/d months 6-9. Daily medroxyprogesterone acetate 5mg by mouth for 12 days at week 30. Leuprolide acetate: Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 9 months. First 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study. Estradiol: Climara transdermal patch 0.075mg/day applied weekly months 6-9 Medroxyprogesterone: Provera 5mg tablets once daily by mouth for 12 days beginning at week 30.

Units	Counts
Participants

Secondary

Changes in Artery Compliance at 9 Months

Changes in carotid artery compliance will be measured using ultrasound in at baseline, 9 months.

Outcome measure was only collected for a subset of the GnRH agonist arm.

Posted

Mean

Standard Deviation

mm^2/mmhgx10^-1

Baseline, 9 months

ID	Title	Description
OG000	GnRH Agonist	Monthly injections of leuprolide acetate 3.75mg for 9 months; first 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study protocol. Weekly application of estradiol patch 0.075mg/d months 6-9. Daily medroxyprogesterone acetate 5mg by mouth for 12 days at week 30. Leuprolide acetate: Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 9 months. First 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study. Estradiol: Climara transdermal patch 0.075mg/day applied weekly months 6-9 Medroxyprogesterone: Provera 5mg tablets once daily by mouth for 12 days beginning at week 30.

Units	Counts
Participants	OG000

Secondary

Changes in Executive Cognitive Function: Trails A, 6 Months

Change in time (seconds) to complete Trails A test between baseline and 6 months. Negative value indicates faster time (better performance) at 6 months compared to baseline.

Posted

Mean

Standard Deviation

seconds

Baseline, 6 months

ID	Title	Description
OG000	Placebo	Monthly placebo injections for 6 months under parent study (FAME) protocol (NCT01712230) Placebo: placebo
OG001	GnRH Agonist	Monthly injections of leuprolide acetate 3.75mg for 9 months; first 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study protocol. Weekly application of estradiol patch 0.075mg/d months 6-9. Daily medroxyprogesterone acetate 5mg by mouth for 12 days at week 30. Leuprolide acetate: Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 9 months. First 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study. Estradiol: Climara transdermal patch 0.075mg/day applied weekly months 6-9 Medroxyprogesterone: Provera 5mg tablets once daily by mouth for 12 days beginning at week 30.

Units	Counts
Participants

Secondary

Changes in Executive Cognitive Function: Trails A, 9 Months

Change in time (seconds) to complete Trails A test between baseline and 9 months. Negative value indicates faster time (better performance) at 9 months compared to baseline.

Outcome measure was only collected for a subset of the GnRH agonist arm.

Posted

Mean

Standard Deviation

time (seconds)

Baseline, 9 months

ID	Title	Description
OG000	GnRH Agonist	Monthly injections of leuprolide acetate 3.75mg for 9 months; first 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study protocol. Weekly application of estradiol patch 0.075mg/d months 6-9. Daily medroxyprogesterone acetate 5mg by mouth for 12 days at week 30. Leuprolide acetate: Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 9 months. First 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study. Estradiol: Climara transdermal patch 0.075mg/day applied weekly months 6-9 Medroxyprogesterone: Provera 5mg tablets once daily by mouth for 12 days beginning at week 30.

Units	Counts
Participants	OG000

Secondary

Changes in Executive Cognitive Function: RAVLT, 6 Months

Change in Rey Auditory Verbal Learning Test from baseline to 6 months.

Score is the change in the number of items correct on delayed recall trial. Scores on the RAVLT range from 0-15 with higher scores indicating better performance. A positive change indicates improvement in recall.

Posted

Mean

Standard Deviation

number of items recalled

Baseline, 6 months

ID	Title	Description
OG000	Placebo	Monthly placebo injections for 6 months under parent study (FAME) protocol (NCT01712230) Placebo: placebo
OG001	GnRH Agonist	Monthly injections of leuprolide acetate 3.75mg for 9 months; first 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study protocol. Weekly application of estradiol patch 0.075mg/d months 6-9. Daily medroxyprogesterone acetate 5mg by mouth for 12 days at week 30. Leuprolide acetate: Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 9 months. First 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study. Estradiol: Climara transdermal patch 0.075mg/day applied weekly months 6-9 Medroxyprogesterone: Provera 5mg tablets once daily by mouth for 12 days beginning at week 30.

Secondary

Changes in Executive Cognitive Function: RAVLT, 9 Months

Change in Rey Auditory Verbal Learning Test from baseline to 9 months.

Outcome measure was only collected for a subset of the GnRH agonist arm.

Posted

Mean

Standard Deviation

number of items recalled

Baseline, 9 months

ID	Title	Description
OG000	GnRH Agonist	Monthly injections of leuprolide acetate 3.75mg for 9 months; first 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study protocol. Weekly application of estradiol patch 0.075mg/d months 6-9. Daily medroxyprogesterone acetate 5mg by mouth for 12 days at week 30. Leuprolide acetate: Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 9 months. First 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study. Estradiol: Climara transdermal patch 0.075mg/day applied weekly months 6-9 Medroxyprogesterone: Provera 5mg tablets once daily by mouth for 12 days beginning at week 30.

Units	Counts
Participants

Secondary

Changes in Executive Cognitive Function: Trails B, 6 Months

Change in time (seconds) to complete Trails B test between baseline and 6 months. Negative value indicates faster time (better performance) at 6 months compared to baseline.

Posted

Mean

Standard Deviation

time (seconds)

Baseline, 6 months

ID	Title	Description
OG000	Placebo	Monthly placebo injections for 6 months under parent study (FAME) protocol (NCT01712230) Placebo: placebo
OG001	GnRH Agonist	Monthly injections of leuprolide acetate 3.75mg for 9 months; first 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study protocol. Weekly application of estradiol patch 0.075mg/d months 6-9. Daily medroxyprogesterone acetate 5mg by mouth for 12 days at week 30. Leuprolide acetate: Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 9 months. First 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study. Estradiol: Climara transdermal patch 0.075mg/day applied weekly months 6-9 Medroxyprogesterone: Provera 5mg tablets once daily by mouth for 12 days beginning at week 30.

Units	Counts
Participants

Secondary

Changes in Executive Cognitive Function: Trails B, 9 Months

Change in time (seconds) to complete Trails B test between baseline and 9 months. Negative value indicates faster time (better performance) at 9 months compared to baseline.

Outcome measure was only collected for a subset of the GnRH agonist arm.

Posted

Mean

Standard Deviation

time (seconds)

Baseline, 9 months

ID	Title	Description
OG000	GnRH Agonist	Monthly injections of leuprolide acetate 3.75mg for 9 months; first 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study protocol. Weekly application of estradiol patch 0.075mg/d months 6-9. Daily medroxyprogesterone acetate 5mg by mouth for 12 days at week 30. Leuprolide acetate: Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 9 months. First 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study. Estradiol: Climara transdermal patch 0.075mg/day applied weekly months 6-9 Medroxyprogesterone: Provera 5mg tablets once daily by mouth for 12 days beginning at week 30.

Units	Counts
Participants	OG000

Secondary

Changes in Executive Cognitive Function: Stroop, 6 Months

Change in number of correct responses in one minute on Stroop Color Word Interference test between baseline and 6 months. A positive number indicates more items correct indicating better performance. There is no maximum score because the test measures how many correct responses a participant can return within one minute (minimum = 0), however 40 or fewer is considered low. The change in the number of correct responses is reported, and so a positive number indicates more correct responses and better/improved cognitive function.

Posted

Mean

Standard Deviation

number correct in one minute

Baseline, 6 months

ID	Title	Description
OG000	Placebo	Monthly placebo injections for 6 months under parent study (FAME) protocol (NCT01712230) Placebo: placebo
OG001	GnRH Agonist	Monthly injections of leuprolide acetate 3.75mg for 9 months; first 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study protocol. Weekly application of estradiol patch 0.075mg/d months 6-9. Daily medroxyprogesterone acetate 5mg by mouth for 12 days at week 30. Leuprolide acetate: Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 9 months. First 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study. Estradiol: Climara transdermal patch 0.075mg/day applied weekly months 6-9 Medroxyprogesterone: Provera 5mg tablets once daily by mouth for 12 days beginning at week 30.

Secondary

Changes in Executive Cognitive Function: Stroop, 9 Months

Change in number of correct responses in one minute on Stroop Color Word Interference test between baseline and 9 months. Positive number indicates more items correct indicating better performance. There is no maximum score because the test measures how many correct responses a participant can return within one minute (minimum = 0), however 40 or fewer is considered low. The change in the number of correct responses is reported, and so a positive number indicates more correct responses and better/improved cognitive function.

Outcome measure was only collected for a subset of the GnRH agonist arm.

Posted

Mean

Standard Deviation

number correct in one minute

Baseline, 9 months

ID	Title	Description
OG000	GnRH Agonist	Monthly injections of leuprolide acetate 3.75mg for 9 months; first 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study protocol. Weekly application of estradiol patch 0.075mg/d months 6-9. Daily medroxyprogesterone acetate 5mg by mouth for 12 days at week 30. Leuprolide acetate: Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 9 months. First 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study. Estradiol: Climara transdermal patch 0.075mg/day applied weekly months 6-9 Medroxyprogesterone: Provera 5mg tablets once daily by mouth for 12 days beginning at week 30.

Secondary

Changes in Executive Cognitive Function: Digits Span Forward and Backward, 6 Months

Change in score on the Digit Span Test between baseline and 6 month. Raw scores on the Digit Span test range from 0-16 (Digits Forward) and 0-10 (Digits Backward) with higher scores indicating better performance. A positive change score indicates improved performance.

Posted

Mean

Standard Deviation

number of correct trials

Baseline, 6 months

ID	Title	Description
OG000	Placebo	Monthly placebo injections for 6 months under parent study (FAME) protocol (NCT01712230) Placebo: placebo
OG001	GnRH Agonist	Monthly injections of leuprolide acetate 3.75mg for 9 months; first 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study protocol. Weekly application of estradiol patch 0.075mg/d months 6-9. Daily medroxyprogesterone acetate 5mg by mouth for 12 days at week 30. Leuprolide acetate: Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 9 months. First 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study. Estradiol: Climara transdermal patch 0.075mg/day applied weekly months 6-9 Medroxyprogesterone: Provera 5mg tablets once daily by mouth for 12 days beginning at week 30.

Secondary

Changes in Executive Cognitive Function: Digits, 9 Months

Change in score on the Digit Span Test between baseline and 9 months. Raw scores on the Digit Span test range from 0-16 (Digits Forward) and 0-10 (Digits Backward) with higher scores indicating better performance. A positive change score indicates improved performance.

Outcome measure was only collected for a subset of the GnRH agonist arm.

Posted

Mean

Standard Deviation

number of trials correct

Baseline, 9 months

ID	Title	Description
OG000	GnRH Agonist	Monthly injections of leuprolide acetate 3.75mg for 9 months; first 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study protocol. Weekly application of estradiol patch 0.075mg/d months 6-9. Daily medroxyprogesterone acetate 5mg by mouth for 12 days at week 30. Leuprolide acetate: Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 9 months. First 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study. Estradiol: Climara transdermal patch 0.075mg/day applied weekly months 6-9 Medroxyprogesterone: Provera 5mg tablets once daily by mouth for 12 days beginning at week 30.

Units	Counts
Participants

Secondary

Changes in Executive Cognitive Function: Controlled Oral Word Association Test, 6 Months

Change in sum of scores on 3 COWAT trials (letters, F, A, and S) between baseline and 6 months. Participants are given one minute to think up as many words as they can associated with each letter (F, A, or S). Raw scores are the total number of words generated across all trials. Higher scores indicate more words generated and better performance. Positive change score indicates an increase in words generated, or improved performance.

Posted

Mean

Standard Deviation

words generated

Baseline, 6 months

ID	Title	Description
OG000	Placebo	Monthly placebo injections for 6 months under parent study (FAME) protocol (NCT01712230) Placebo: placebo
OG001	GnRH Agonist	Monthly injections of leuprolide acetate 3.75mg for 9 months; first 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study protocol. Weekly application of estradiol patch 0.075mg/d months 6-9. Daily medroxyprogesterone acetate 5mg by mouth for 12 days at week 30. Leuprolide acetate: Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 9 months. First 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study. Estradiol: Climara transdermal patch 0.075mg/day applied weekly months 6-9 Medroxyprogesterone: Provera 5mg tablets once daily by mouth for 12 days beginning at week 30.

Secondary

Changes in Executive Cognitive Function: Controlled Oral Word Association Test, 9 Months

Change in sum of scores on 3 COWAT trials (letters, F, A, and S) between baseline and 9 months. Participants are given one minute to think up as many words as they can associated with each letter (F, A, or S). Raw scores are the total number of words generated across all trials. Higher scores indicate more words generated and better performance. Positive change score indicates an increase in words generated, or improved performance.

Posted

Mean

Standard Deviation

words generated

Baseline, 9 months

ID	Title	Description
OG000	GnRH Agonist	Monthly injections of leuprolide acetate 3.75mg for 9 months; first 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study protocol. Weekly application of estradiol patch 0.075mg/d months 6-9. Daily medroxyprogesterone acetate 5mg by mouth for 12 days at week 30. Leuprolide acetate: Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 9 months. First 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study. Estradiol: Climara transdermal patch 0.075mg/day applied weekly months 6-9 Medroxyprogesterone: Provera 5mg tablets once daily by mouth for 12 days beginning at week 30.

Units	Counts
Participants

ID	Term
D060825	Cognitive Dysfunction
D002318	Cardiovascular Diseases

ID	Term
D003072	Cognition Disorders
D019965	Neurocognitive Disorders
D001523	Mental Disorders

ID	Term
D016729	Leuprolide
D004958	Estradiol
D008525	Medroxyprogesterone
D017258	Medroxyprogesterone Acetate

ID	Term
D007987	Gonadotropin-Releasing Hormone
D010906	Pituitary Hormone-Releasing Hormones
D007028	Hypothalamic Hormones
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D009479	Neuropeptides
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D009842	Oligopeptides
D009419	Nerve Tissue Proteins
D011506	Proteins
D004963	Estrenes
D004962	Estranes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D045166	Estradiol Congeners
D012739	Gonadal Steroid Hormones
D042341	Gonadal Hormones
D006908	Hydroxyprogesterones
D011374	Progesterone
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Monthly placebo injections for 6 months under parent study (FAME) protocol (NCT01712230) Placebo: placebo	0	5	0	5	0	5
EG001	GnRH Agonist	Monthly injections of leuprolide acetate 3.75mg for 9 months; first 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study protocol. Weekly application of estradiol patch 0.075mg/d months 6-9. Daily medroxyprogesterone acetate 5mg by mouth for 12 days at week 30. Leuprolide acetate: Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 9 months. First 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study. Estradiol: Climara transdermal patch 0.075mg/day applied weekly months 6-9 Medroxyprogesterone: Provera 5mg tablets once daily by mouth for 12 days beginning at week 30.	0	12	0	12	1	12