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

Menopause Clinical Trial

Official title:

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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00950781
• Other study ID #: IRB# 17569
• Status: Completed
• Start date: January 2009
• Est. completion date: February 2010

Study information

• Verified date: June 2019
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Menopause

Intervention

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.

Locations

Country	Name	City	State
United States	Cedars-Sinai Women's Heart Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	circulation at baseline and after acute ACTH stimulation		2 hours
Secondary	urine collection of menopausal women with VMS pre and post treatment		24 hours