Status:
COMPLETED
Cortisol Levels on Menopausal Symptoms - Ancillary (Addendum) Study to Protocol 16997
Lead Sponsor:
Cedars-Sinai Medical Center
Conditions:
Menopause
Eligibility:
FEMALE
40-70 years
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00950781
Start Date
January 1 2009
End Date
February 1 2010
Last Update
June 7 2019
Active Locations (1)
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1
Cedars-Sinai Women's Heart Center
Los Angeles, California, United States, 90048