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NCT00950781 · ClinicalTrials.gov registry record
Cortisol Levels on Menopausal Symptoms - Ancillary (Addendum) Study to Protocol 16997
A clinical trial, sponsored by Cedars-Sinai Medical Center.
- Completed
- Registry status
- 45
- Enrollment target
NCT00950781: Completed study, sponsored by Cedars-Sinai Medical Center.
NCT00950781 is a clinical trial that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 45 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00950781 has completed, sponsored by Cedars-Sinai Medical Center.
- COMPLETED
- Registry status
- 45 participants
- Enrollment target
Study Summary
This is an ancillary study to Protocol 16997 to examine the stress hormone level in women with menopausal symptoms. This ancillary project will collect additional data from the 45 subjects enrolled in Protocol 16997 (no subjects have enrolled in Protocol 16997 so far). This study protocol differs from the main protocol (16997) because it will include an ACTH (Hormone) Stimulation Test which will assess the functioning of stress response in the subjects at entry and exit. Subjects will undergo the ACTH test for this ancillary protocol in the morning when they complete 24-hour urine collection for Protocol 16997. The ACTH (Hormone) Stimulation Test will not be done in the main protocol 16997. During the ACTH test an IV will be placed in subjects arms, 25mL of blood will be drawn at -30 minutes and 6mL of blood will be drawn at -15 minutes and 0 minutes respectively. Following, 0.25mg of ACTH will be injected intravenous over 60 seconds, and a final 12mL of blood will be drawn 60 minutes later. That is, a total of 50mL of blood will be drawn to test serum blood hormone levels from the subjects during the ACTH (Hormone) Stimulation Test. The 24 hour cortisol data collected in the main protocol 16997 will be used for this study analysis. When subjects are consented for Protocol 16997, they will also be consented for this ancillary study. In addition to the consent visit, subjects will have two study specific visits (entry and exit) for this ancillary study. The PI will schedule the specific visits for this study to be in conjunction with those scheduled for Protocol 16997. There is no collaborations with other sites in the ancillary study.
Interventions
- PROCEDURE ACTH
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2009-01 |
| Est. Completion | 2010-02 |
What the finished NCT00950781 record still lists
NCT00950781 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 45 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which ACTH is the first listed.
NCT00950781 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00950781 about?
NCT00950781 is a clinical study titled "Cortisol Levels on Menopausal Symptoms - Ancillary (Addendum) Study to Protocol 16997". This is an ancillary study to Protocol 16997 to examine the stress hormone level in women with menopausal symptoms. This ancillary project will collect additional data from the 45 subjects enrolled in Protocol 16997 (no subjects have enrolled in Protocol 16997 so far). This study protocol differs fr...
What is the current status of trial NCT00950781?
This trial is currently completed. The enrollment target is 45 participants. The study started on 2009-01. Estimated completion is 2010-02.
What interventions are being tested in trial NCT00950781?
The interventions under investigation include: ACTH (PROCEDURE).
Who is sponsoring clinical trial NCT00950781?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
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