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

Cortisol Levels on Menopausal Vasomotor Symptoms - an Ancillary (Addendum) Study to the "Impact of Traditional Acupuncture on Menopausal Vasomotor Symptoms, Psychological Stress and the Hypothalamic Pituitary Adrenal (HPA) - Sympathetic Nervous System (SNS) Axis: A Randomized, Controlled Trial"

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.

Study Overview

• Status: Completed
• Conditions: Menopause
• Intervention / Treatment: Procedure: ACTH

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Women's Heart Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Menopausal women

Description

Inclusion Criteria:

1. Women with menopausal VMS bothersome enough to warrant treatment;
2. Minimum of 7 hot flashes per day (on average);
3. Age limits: women ages 40-70 who have had at least one missed menstrual cycle or have undergone spontaneous menopause, women of any age who have medically induced menopause, women of any age who have had oophorectomy;
4. Informed written consent;
5. Ability to follow treatment protocols.

Exclusion Criteria:

Exclusion Criteria (cohort)

1. Concomitant illness with reasonable likelihood of limiting survival to less than one year;
2. Current substance abuse (alcohol or drug);
3. Pregnancy known, suspected or planned in next year.

Exclusion Criteria (TA intervention)

1. Other concomitant menopause treatment;
2. Participating in acupuncture treatment or formal psychological stress management program within the last year;
3. Participating in another treatment for VMS, unless willing to stop it 4 weeks in advance of participation;
4. HIV infection, chronic or active hepatitis or other blood-borne illness.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Group

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
circulation at baseline and after acute ACTH stimulation	2 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
urine collection of menopausal women with VMS pre and post treatment	24 hours

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Investigators: Study Director: C. Noel Bairey Merz, MD, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: July 31, 2009
• First Submitted That Met QC Criteria: July 31, 2009
• First Posted (Estimate): August 3, 2009

Study Record Updates

• Last Update Posted (Actual): June 7, 2019
• Last Update Submitted That Met QC Criteria: June 6, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Menopause; Cortisol; ACTH
• Other Study ID Numbers: IRB# 17569

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes