Protocol - Hormonal Therapy
Female participants are asked whether they have ever used prescription female hormones (number of months taken, types, dosage) and then asked whether they are currently using it. They are asked whether they are using any over-the-counter preparations for hormone replacement or post-menopause symptoms.
Note: the prepopulated/embedded dates of the original study protocol were removed for clarity of Toolkit users.
1. Have you used prescription female hormones? (Not including contraceptives.)
[ ] Yes
a) How many months did you use hormones?
[ ] 1 - 4 months
[ ] 5 - 9 months
[ ] 10 - 14 months
[ ] 15 - 19 months
[ ] 20 - 25 months
[ ] 26 - 30 months
[ ] 31 - 35 months
[ ] 36+ months
b) Are you currently using them (within the last month)?
[ ] Yes
[ ] No
If no, skip to part d
c) Mark the type(s) of hormones you are CURRENTLY using:
[ ] Combined:
[ ] Prempro,
[ ] Premphase,
[ ] Combipatch,
[ ] FemHRT
[ ] Estrogen
[ ] Oral Premarin or Conjugated estrogen
[ ] Patch Estrogen
[ ] Vaginal Estrogen
[ ] Estrace
[ ] Estrogen gels, creams, or sprays on skin
[ ] Estratest
[ ] Other Estrogen Specify:____________
[ ] Progesterone/Progestin:
[ ] Provera/Cycrin/MPA
[ ] Vaginal
[ ] Micronized (e.g., Prometrium)
[ ] Other progesterone (specify type):___________
d) If you used oral conjugated estrogen (e.g., Premarin), what dose did you usually take?
[ ] .30 mg/day or less
[ ] .45 mg/day
[ ] .625 mg/day
[ ] .9 mg/day
[ ] 1.25 mg/day or higher
[ ] Unsure
[ ] Did not take oral conjugated estrogen
[ ] No (skip to 2)
2. Are you currently using any of these over-the-counter (OTC) preparations for hormone replacement?
[ ] Soy estrogen products
[ ] Black cohosh (e.g., Remifemin)
[ ] Natural progesterone cream/wild yam
[ ] Other OTC
Protocol Name from Source:
Nurses’ Health Study II (NHS II)
Personnel and Training Required
Pencil and paper
|Specialized requirements for biospecimen collection||No|
|Average time of greater than 15 minutes in an unaffected individual||No|
Mode of Administration
Women aged 25-42 in 1989.
Among several vetted national surveys of hormonal therapy, this protocol is the most comprehensive, while not being too burdensome within the context of a general survey.
|Common Data Elements (CDE)||Female Endocrine Therapy||3007460||CDE Browser|
Process and Review
The Expert Review Panel #5 (ERP 5) reviewed the measures in the Reproductive Health domain.
Guidance from ERP 5 includes the following:
New Data Dictionary
Back-compatible: there are changes to the Data Dictionary, previous version of the Data Dictionary and Variable mapping in Toolkit archive (link)
Harvard Medical School. (2015). Nurses’ Health Study II, 2015. Boston, MA. Question numbers 7-8.
Townsend, M. K., Curhan, G. C., Resnick, N. M., & Grodstein, F. (2009). Postmenopausal hormone therapy and incident urinary incontinence in middle-aged women. American Journal of Obstetrics and Gynecology, 200(1), 86.e1-5.
|Variable Name||Variable ID||Variable Description||Version||dbGaP Mapping|
April 11, 2017
A question to determine whether a female has ever taken hormonal therapy for treatment or prevention of cancer or for another reason. As hormonal therapy is known to affect risk of cardiovascular disease and cancer, it is an important environmental risk factor for women.
To assess use of hormonal therapy.
Reproductive health, estrogen, Nurses’ Health Study, NHS