Trial · NCT00608062
Sex Hormones and Atherosclerosis Prevention in Perimenopausal Women
NCT00608062, Not applicable, Completed, University of Colorado, Denver; results first posted 2020-12-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Sex Hormones and Atherosclerosis Prevention in Perimenopausal Women. Trials, record NCT00608062. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00608062
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sex Hormones and Atherosclerosis Prevention in Perimenopausal Women
- NCT number
- NCT00608062
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 155 participants, actual
- Lead sponsor
- University of Colorado, Denver
- Conditions
- Arterial Stiffening, Aging, Menopause
- Interventions
- GnRHant - Ganirelix acetate, Transdermal estradiol patch, Transdermal placebo patch
- First posted
- 2008-02-06
- Last updated
- 2020-12-24
- Results first posted
- 2020-12-24
- Limitations and caveats
Budget cuts lead to: 1) endothelial cell protein expression outcome not analyzed and deleted; 2) small numbers of early and late perimenopausal groups, thus, it was collapsed into 1 peri group. Ultrasound image quality also lead to small numbers.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Arterial Stiffness (Carotid Artery Compliance) During Saline | Baseline, day 4 of GnRHant and day 7 of GnRHant and estradiol or placebo treatment | Carotid artery compliance measured by carotid artery ultrasound and brachial artery blood pressure |
| Primary | Endothelial Function | Baseline, day 4 of GnRHant and Day 7 of GnRHant and estradiol or placebo treatment | Brachial artery flow-mediated dilation (FMD) assessed by ultrasound. This other outcome measure was originally specified as "Secondary" in error and has been updated to "Primary" to be consistent with the protocol. |
| Other | Supine Brachial Blood Pressures | Baseline, day 4 of GnRHant and day 7 of GnRHant and estradiol or placebo treatment | |
| Other | Estradiol | Baseline, day 4 of GnRHant and day 7 of GnRHant and estradiol or placebo treatment | This other outcome measure was originally specified as "Secondary" in error and has been updated to "Other, Pre-specified" to be consistent with the protocol. Serum estradiol for clinical characteristics and to detect changes in estradiol levels with the interventions. |
| Other | Progesterone | Baseline, Day 4 GnRHant, Day 7 GnRHant+Add-back | This other outcome measure was originally specified as "Secondary" in error and has been updated to "Other, Pre-specified" to be consistent with the protocol. Serum progesterone was measured for clinical characteristics and to determine changes in sex hormones. |
| Other | Total Antioxidant Status (TAS) | Baseline, Day 4 GnRHant, Day 7 GnRHant+Add-back | This other outcome measure was originally specified as "Secondary" in error and has been updated to "Other, Pre-specified" to be consistent with the protocol. TAS is an antioxidant and is a biomarker of oxidative stress. |
| Other | Endothelin-1 (ET-1) | Baseline, Day 4 GnRHant, Day 7 GnRHant+Add-back | This other outcome measure was originally specified as "Secondary" in error and has been updated to "Other, Pre-specified" to be consistent with the protocol. |
| Other | Plasma Norepinephrine | Baseline, Day 4 GnRHant, Day 7 GnRHant+Add-back | This other outcome measure was originally specified as "Secondary" in error and has been updated to "Other, Pre-specified" to be consistent with the protocol. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Arterial Stiffness (Carotid Artery Compliance) During Saline | Baseline, day 4 of GnRHant and day 7 of GnRHant and estradiol or placebo treatment | Early and late perimenopausal were collapsed into 1 perimenopausal group | mm2/mm Hg×10-1 | MEAN |
| PRIMARY | Endothelial Function | Baseline, day 4 of GnRHant and Day 7 of GnRHant and estradiol or placebo treatment | Numbers for some groups are reduced because of poor ultrasound image quality. | % Diameter Change | MEAN |
| OTHER_PRE_SPECIFIED | Supine Brachial Blood Pressures | Baseline, day 4 of GnRHant and day 7 of GnRHant and estradiol or placebo treatment | mmHg | MEAN | |
| OTHER_PRE_SPECIFIED | Estradiol | Baseline, day 4 of GnRHant and day 7 of GnRHant and estradiol or placebo treatment | Data are for subsample of women who completed FMD with useuable data | pmol/L | MEDIAN |
| OTHER_PRE_SPECIFIED | Progesterone | Baseline, Day 4 GnRHant, Day 7 GnRHant+Add-back | Data presented are from those women who had FMD with usable images | nmol/L | MEDIAN |
| OTHER_PRE_SPECIFIED | Total Antioxidant Status (TAS) | Baseline, Day 4 GnRHant, Day 7 GnRHant+Add-back | Data are presented from participants that completed the endothelial function testing and who had usable images. | nmol/L | MEAN |
| OTHER_PRE_SPECIFIED | Endothelin-1 (ET-1) | Baseline, Day 4 GnRHant, Day 7 GnRHant+Add-back | Data are presented from women who completed endothelial function testing and whom had usable images | pg/mL | MEAN |
| OTHER_PRE_SPECIFIED | Plasma Norepinephrine | Baseline, Day 4 GnRHant, Day 7 GnRHant+Add-back | Data are presented from women who completed endothelial function testing and whom had useable images. | pg/mL | MEDIAN |
Source ClinicalTrials.gov
Results by group150
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Arterial Stiffness (Carotid Artery Compliance) During Saline | Pre1 | Baseline | 1.31 | Standard Deviation 0.27 | mm2/mm Hg×10-1 |
| Arterial Stiffness (Carotid Artery Compliance) During Saline | Pre2 | Baseline | 1.34 | Standard Deviation 0.18 | mm2/mm Hg×10-1 |
| Arterial Stiffness (Carotid Artery Compliance) During Saline | Peri1 | Baseline | 0.90 | Standard Deviation 0.27 | mm2/mm Hg×10-1 |
| Arterial Stiffness (Carotid Artery Compliance) During Saline | Peri2 | Baseline | 1.02 | Standard Deviation 0.33 | mm2/mm Hg×10-1 |
| Arterial Stiffness (Carotid Artery Compliance) During Saline | Post1 | Baseline | 0.89 | Standard Deviation 0.25 | mm2/mm Hg×10-1 |
| Arterial Stiffness (Carotid Artery Compliance) During Saline | Post2 | Baseline | 0.74 | Standard Deviation 0.23 | mm2/mm Hg×10-1 |
| Arterial Stiffness (Carotid Artery Compliance) During Saline | Pre1 | GnRHant alone | 1.27 | Standard Deviation 0.27 | mm2/mm Hg×10-1 |
| Arterial Stiffness (Carotid Artery Compliance) During Saline | Pre2 | GnRHant alone | 1.19 | Standard Deviation 0.34 | mm2/mm Hg×10-1 |
| Arterial Stiffness (Carotid Artery Compliance) During Saline | Peri1 | GnRHant alone | 0.89 | Standard Deviation 0.27 | mm2/mm Hg×10-1 |
| Arterial Stiffness (Carotid Artery Compliance) During Saline | Peri2 | GnRHant alone | 0.94 | Standard Deviation 0.29 | mm2/mm Hg×10-1 |
1 to 10 of 150Source ClinicalTrials.gov
See all 150 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pre1 | 12 | |
| Overall Study | STARTED | Pre2 | 12 | |
| Overall Study | STARTED | Peri1 | 19 | |
| Overall Study | STARTED | Peri2 | 21 | |
| Overall Study | STARTED | Post1 | 13 | |
| Overall Study | STARTED | Post2 | 15 | |
| Overall Study | COMPLETED | Pre1 | 12 | |
| Overall Study | COMPLETED | Pre2 | 12 | |
| Overall Study | COMPLETED | Peri1 | 19 | |
| Overall Study | COMPLETED | Peri2 | 21 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events54
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 | Cardiovascular/neurology | Injury, poisoning and procedural complications | Pre1 | 0 | 12 | 0 |
| other | Cardiovascular/neurology | Injury, poisoning and procedural complications | Pre2 | 0 | 12 | 0 |
| other | Cardiovascular/neurology | Injury, poisoning and procedural complications | Peri1 | 0 | 19 | 0 |
| other | Cardiovascular/neurology | Injury, poisoning and procedural complications | Peri2 | 1 | 21 | 1 |
| other | Cardiovascular/neurology | Injury, poisoning and procedural complications | Post1 | 0 | 13 | 0 |
| other | Cardiovascular/neurology | Injury, poisoning and procedural complications | Post2 | 1 | 15 | 1 |
| other | Bloating | Gastrointestinal disorders | Pre1 | 2 | 12 | 2 |
| other | Bloating | Gastrointestinal disorders | Pre2 | 1 | 12 | 1 |
| other | Bloating | Gastrointestinal disorders | Peri1 | 4 | 19 | 4 |
| other | Bloating | Gastrointestinal disorders | Peri2 | 2 | 21 | 2 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pre1 | 0 | 12 |
| Total, all-cause mortality | Pre2 | 0 | 12 |
| Total, all-cause mortality | Peri1 | 0 | 19 |
| Total, all-cause mortality | Peri2 | 0 | 21 |
| Total, all-cause mortality | Post1 | 0 | 13 |
| Total, all-cause mortality | Post2 | 0 | 15 |
| Total, other adverse events | Pre1 | 8 | 12 |
| Total, other adverse events | Pre2 | 4 | 12 |
| Total, other adverse events | Peri1 | 9 | 19 |
| Total, other adverse events | Peri2 | 8 | 21 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers8
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|---|---|---|---|
| R01AG027678 | Biological Mechanisms of Arterial Stiffening With Age and Estrogen Deficiency | MOREAU, KERRIE | UNIVERSITY OF COLORADO DENVER | NATIONAL INSTITUTE ON AGING | 2006 to 2010 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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/NCT00608062
GET https://conductscience.org/api/trials/v1/NCT00608062/results?page=2