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Cortisol Levels on Menopausal Symptoms - Ancillary (Addendum) Study to Protocol 16997

NCT00950781 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2019-06-07

No results posted yet for this 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.

Conditions

Interventions

PROCEDURE

ACTH

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.

Sponsors & Collaborators

  • Cedars-Sinai Medical Center

    lead OTHER

Principal Investigators

  • C. Noel Bairey Merz, MD · Cedars-Sinai Medical Center

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00950781 on ClinicalTrials.gov