Trial · NCT01153581
Sex Hormones and Orthostatic Tolerance
NCT01153581, Phase 2, Completed, Yale University; results first posted 2017-01-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sex Hormones and Orthostatic Tolerance. Trials, record NCT01153581. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01153581
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sex Hormones and Orthostatic Tolerance
- NCT number
- NCT01153581
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 109 participants, actual
- Lead sponsor
- Yale University
- Conditions
- Orthostatic Intolerance
- Interventions
- Ganirelix acetate, 17β-Oestradiol, Progesterone
- First posted
- 2010-06-30
- Last updated
- 2018-12-13
- Results first posted
- 2017-01-30
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Orthostatic Tolerance | 2 months | We used a measure called cumulative stress index to determine orthostatic tolerance, which is the amount of time at a level of negative pressure each subject can maintain before feeling as if she is going to pass out. This is calculated by multiplying the pressure in mm Hg by the time in min. |
| Primary | Baroreceptor Function | 2 months | This is a measure of how the body responds to changes in pressure induced by changes in position such as sitting, lying standing. The pressure changes are induced by gravity. The measurement described below to assess baroreceptor function is units of change in forearm vascular resistance for a given change in lower body negative pressure. This allows us to determine how good the body is at sending signals to the periphery to respond to postural changes. Baroreflex sensitivity is defined as the change in interbeat interval (IBI) in milliseconds per unit change in BP. For example, when the BP rises by 10 mmHg and IBI increases by 100 ms, BRS would be 100/10 = 10 ms/mmHg. |
| Primary | Skin Microvascular Responses | 2 months | Changes in blood flow in the small vessel in the skin are measured in response to sequential heat and drug stimulation. It is measured in volts, and then corrected for a maximum level and expressed as "% max." This is measured with a Laser Doppler probes, which measures volts. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Orthostatic Tolerance | 2 months | mmHg*min | MEAN | |
| PRIMARY | Baroreceptor Function | 2 months | Women with low and high orthostatic tolerance | ms/mm Hg | MEAN |
| PRIMARY | Skin Microvascular Responses | 2 months | Women with and without orthostatic intolerance | Percent of max volts | MEAN |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Orthostatic Tolerance | Women With and Without Orthostatic Intolerance | 634 | Standard Deviation 213 | mmHg*min | |
| Baroreceptor Function | Low Orthostatic Tolerance | 0.140 | Standard Error 0.034 | ms/mm Hg | |
| Baroreceptor Function | High Orthostatic Tolerant | 0.128 | Standard Error 0.044 | ms/mm Hg | |
| Skin Microvascular Responses | Women With Orthostatic Intolerance | 4.02 | Standard Error 0.39 | Percent of max volts | |
| Skin Microvascular Responses | Women Without Orthostatic Tolerance | 5.18 | Standard Error 0.31 | Percent of max volts |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Women With and Without Orthostatic Intolerance | 109 | |
| Overall Study | COMPLETED | Women With and Without Orthostatic Intolerance | 109 | |
| Overall Study | NOT COMPLETED | Women With and Without Orthostatic Intolerance | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ganirelix Acetate | ||
| Total, all-cause mortality | 17β-Oestradiol | ||
| Total, all-cause mortality | Progesterone | ||
| Total, other adverse events | Ganirelix Acetate | 0 | 109 |
| Total, other adverse events | 17β-Oestradiol | 0 | 109 |
| Total, other adverse events | Progesterone | 0 | 109 |
| Total, serious adverse events | Ganirelix Acetate | 0 | 109 |
| Total, serious adverse events | 17β-Oestradiol | 0 | 109 |
| Total, serious adverse events | Progesterone | 0 | 109 |
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 |
|---|---|---|---|---|---|
| R01HL071159 | Estrogen & Progesterone Effects on Orthostatic Tolerance | STACHENFELD, NINA | JOHN B. PIERCE LABORATORY, INC. | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2003 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/NCT01153581
GET https://conductscience.org/api/trials/v1/NCT01153581/registered