Trial · NCT02122198

Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women

NCT02122198, Not applicable, Completed, University of Colorado, Denver; results first posted 2022-01-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women. Trials, record NCT02122198. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02122198

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women
NCT number: NCT02122198
Status: Completed
Phases: Not applicable
Enrollment: 17 participants, actual
Lead sponsor: University of Colorado, Denver
Conditions: Cognitive Impairment, Executive Dysfunction, Endothelial Dysfunction, Cardiovascular Disease
Interventions: Leuprolide acetate, Estradiol, Medroxyprogesterone, Placebo
First posted: 2014-04-24
Last updated: 2022-01-10
Results first posted: 2022-01-10

Source ClinicalTrials.gov

Registered outcomes18

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Changes in Prefrontal Cortex Brain Activation at 6 Months	Baseline, 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.
Primary	Changes in Prefrontal Cortex Brain Activation at 9 Months	Baseline, 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.
Secondary	Changes in Endothelial Function at 6 Months	Baseline, 6 months	Changes in endothelial function will be measured using brachial artery flow-mediated dilation at baseline, 6 months
Secondary	Changes in Endothelial Function at 9 Months	Baseline, 9 months	Changes in endothelial function will be measured using brachial artery flow-mediated dilation at baseline, 9 months
Secondary	Changes in Artery Compliance at 6 Months	Baseline, 6 months	Changes in carotid artery compliance will be measured using ultrasound in at baseline, 6 months.
Secondary	Changes in Artery Compliance at 9 Months	Baseline, 9 months	Changes in carotid artery compliance will be measured using ultrasound in at baseline, 9 months.
Secondary	Changes in Executive Cognitive Function: Trails A, 6 Months	Baseline, 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.
Secondary	Changes in Executive Cognitive Function: Trails A, 9 Months	Baseline, 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.
Secondary	Changes in Executive Cognitive Function: RAVLT, 6 Months	Baseline, 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.
Secondary	Changes in Executive Cognitive Function: RAVLT, 9 Months	Baseline, 9 months	Change in Rey Auditory Verbal Learning Test from baseline to 9 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.

1 to 10 of 18Source ClinicalTrials.gov

See all 18 registered outcomes

Outcomes18

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Changes in Prefrontal Cortex Brain Activation at 6 Months	Baseline, 6 months		beta-weight	MEAN
PRIMARY	Changes in Prefrontal Cortex Brain Activation at 9 Months	Baseline, 9 months	This outcome measure was only collected for a subset of the GnRH Agonist group.	beta-weight	MEAN
SECONDARY	Changes in Endothelial Function at 6 Months	Baseline, 6 months	This outcome cannot be reported due to corruption of the collected image data.
SECONDARY	Changes in Endothelial Function at 9 Months	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.
SECONDARY	Changes in Artery Compliance at 6 Months	Baseline, 6 months		mm^2/mmhgx10^-1	MEAN
SECONDARY	Changes in Artery Compliance at 9 Months	Baseline, 9 months	Outcome measure was only collected for a subset of the GnRH agonist arm.	mm^2/mmhgx10^-1	MEAN
SECONDARY	Changes in Executive Cognitive Function: Trails A, 6 Months	Baseline, 6 months		seconds	MEAN
SECONDARY	Changes in Executive Cognitive Function: Trails A, 9 Months	Baseline, 9 months	Outcome measure was only collected for a subset of the GnRH agonist arm.	time (seconds)	MEAN
SECONDARY	Changes in Executive Cognitive Function: RAVLT, 6 Months	Baseline, 6 months		number of items recalled	MEAN
SECONDARY	Changes in Executive Cognitive Function: RAVLT, 9 Months	Baseline, 9 months	Outcome measure was only collected for a subset of the GnRH agonist arm.	number of items recalled	MEAN

1 to 10 of 18Source ClinicalTrials.gov

See all 18 outcomes

Results by group33

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Changes in Prefrontal Cortex Brain Activation at 6 Months	Placebo	Frontal Pole (L)	90.64	Standard Deviation 3.88	beta-weight
Changes in Prefrontal Cortex Brain Activation at 6 Months	GnRH Agonist	Frontal Pole (L)	-62.20	Standard Deviation 57.61	beta-weight
Changes in Prefrontal Cortex Brain Activation at 6 Months	Placebo	Frontal Orbital Cortex (L)	28.07	Standard Deviation 37.48	beta-weight
Changes in Prefrontal Cortex Brain Activation at 6 Months	GnRH Agonist	Frontal Orbital Cortex (L)	-79.04	Standard Deviation 71.85	beta-weight
Changes in Prefrontal Cortex Brain Activation at 6 Months	Placebo	Superior Frontal Gyrus (R)	92.45	Standard Deviation 33.66	beta-weight
Changes in Prefrontal Cortex Brain Activation at 6 Months	GnRH Agonist	Superior Frontal Gyrus (R)	-53.05	Standard Deviation 41.13	beta-weight
Changes in Prefrontal Cortex Brain Activation at 9 Months	GnRH Agonist	Frontal Pole (L)	-27.15	Standard Deviation 67.37	beta-weight
Changes in Prefrontal Cortex Brain Activation at 9 Months	GnRH Agonist	Frontal Orbital Cortex (L)	-88.87	Standard Deviation 0.34	beta-weight
Changes in Prefrontal Cortex Brain Activation at 9 Months	GnRH Agonist	Superior Frontal Gyrus (R)	-77.23	Standard Deviation 68.22	beta-weight
Changes in Artery Compliance at 6 Months	Placebo		-0.048	Standard Deviation 0.057	mm^2/mmhgx10^-1

1 to 10 of 33Source ClinicalTrials.gov

See all 33 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	5
Overall Study	STARTED	GnRH Agonist	12
Overall Study	COMPLETED	Placebo	3
Overall Study	COMPLETED	GnRH Agonist	10
Overall Study	NOT COMPLETED	Placebo	2
Overall Study	NOT COMPLETED	GnRH Agonist	2

Source ClinicalTrials.gov

Adverse events2

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	calcification of the falx cerebri right of midline	Nervous system disorders	Placebo	0	5	0
other	calcification of the falx cerebri right of midline	Nervous system disorders	GnRH Agonist	1	12	1

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	5
Total, all-cause mortality	GnRH Agonist	0	12
Total, other adverse events	Placebo	0	5
Total, other adverse events	GnRH Agonist	1	12
Total, serious adverse events	Placebo	0	5
Total, serious adverse events	GnRH Agonist	0	12

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
UL1TR001082	Colorado Clinical and Translational Sciences Institute	SOKOL, RONALD J.	UNIVERSITY OF COLORADO DENVER	NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES	2013 to 2017

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
GnRH Agonist vs Placebo: deaths from any cause	Trial comparisons
GnRH Agonist vs Placebo: serious adverse events	Trial comparisons

Tests6

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Digit Span Test	Secondary outcome	ConductCognition
Stroop Color-Word Test	Secondary outcome	ConductCognition
Trail Making Test A	Secondary outcome	ConductCognition
Trail Making Test B	Secondary outcome	ConductCognition
Verbal Fluency	Secondary outcome	ConductCognition
Verbal Learning	Secondary outcome	ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02122198

GET https://conductscience.org/api/trials/v1/NCT02122198/results?page=2

API reference For AI assistants