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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00950781

Enrollment

Registered

2009-08-03

Start date

2009-01-31

Completion date

2010-02-28

Last updated

2019-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopause

Keywords

Menopause, Cortisol, ACTH

Brief 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

PROCEDUREACTH

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.

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 70 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026