An interventional study of Soy Isoflavones in Migraine Headache, sponsored by Thomas Jefferson University. Completed at 1 site in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2009-01-23.
Sponsored by Thomas Jefferson University · Not applicable and Interventional
The purpose of this trial is to study the use of soy isoflavones in the prevention of menstrually-associated migraines. Additionally, this trial may provide insight into the menstrual cycle and menstrually-related headaches in women. With this information, we may be able to change current treatment methods or even develop new methods in order to advance current approaches in the treatment of menstrual migraine.
Many women have increased headache attacks at the time of their period (menses). The migraines experienced around the menstrual cycle are most often associated with premenstrual complaints such as nausea, backache and breast tenderness. The condition of hormone-related headache (i.e. menstrual migraine) is unclear.
Soy isoflavones have been used to alleviate the symptoms of menopause. They contain natural estrogens (female hormones). Since menstrual migraine is thought to be associated with the withdrawal of estrogen, or the natural fall of estrogen levels, the use of this natural source of estrogen may be helpful in the prevention of menstrually-associated migraine.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 25 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Thomas Jefferson University is the lead sponsor of 384 studies on the registry; 71 are open to participants now.
Of its 44 completed or terminated interventional studies of FDA-regulated products, 20 (45%) have results posted.
Counted across the registry records on this site, refreshed daily.
•Subjects who have experienced regular menstrual cycles for the past 6 months (every 21 to 35 days) •Subjects who have a history of migraine with or without aura that meets IHS criteria for at least 6 months preceding the study. •Subjects who have headaches associated with menstruation, either pre-menstrually or menstrually (defined as from day -3 through the cessation of menstrual flow) at least 75% of the time (3 out of the past 4 months). •Subjects must experience a menstrually-associated migraine during the baseline month, as defined above. •Subjects must be able to accurately predict onset on menses (within 2 days). This will be confirmed during the baseline month. •Subjects who have been on stable headache preventive medications for the 3 months prior to screening. •Subject has negative urine pregnancy test prior to study entry, and is using or agrees to use for the duration of participation a medically acceptable form of contraception (as determined by investigator), if female of child-bearing potential •Subject is able to understand and comply with all study requirements •Subject provides written informed consent prior to any screening procedures being conducted
Exclusion Criteria:
To compare headache outcome measures between baseline and soy treatment periods. Headache outcome measures include frequency and duration of menstrually-associated migraine (MAM), as well as presence or absence of associated symptoms
Duration of MAM headaches
Maximum headache intensity
Incidence of MAM headache associated symptoms
Duration of MAM headache associated symptoms
Maximum functional impairment score during MAM headache
Incidence of use of rescue medication for the treatment of a MAM attack
Patient satisfaction score at the end of each treatment period
Describe headaches associated with menstruation
Describe the association of headache to premenstrual symptoms.
Explore premonitory symptoms in the menstrual migraine population
Compare questionnaire data collected at screening visit to questionnaire data collected at termination visit.
Assess electronic diary effectiveness in capturing diary information in this population
This study is completed, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.
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Thomas Jefferson University