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 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.

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Key information

Conditions

Menopause

Age range

40 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Cedars-Sinai Women's Heart Center

Los Angeles, California, 90048, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women with menopausal VMS bothersome enough to warrant treatment;
Minimum of 7 hot flashes per day (on average);
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;
Informed written consent;
Ability to follow treatment protocols.

Exclusion criteria

(cohort)

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

Exclusion criteria

(TA intervention)

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

Treatment and study plan

ACTH

Procedure

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.

Primary outcomes

circulation at baseline and after acute ACTH stimulation

Time frame: 2 hours

Secondary outcomes

urine collection of menopausal women with VMS pre and post treatment

Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study 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"

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Aug 3, 2009
Registry last updated: Jun 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed