Clinical Study Examining Use of an Over-the-Counter Supplement for the Prevention of Menstrually-Associated Migraine Headache
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|ClinicalTrials.gov Identifier: NCT00203255|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : January 23, 2009
|Condition or disease||Intervention/treatment||Phase|
|Migraine Headache||Drug: Soy Isoflavones||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Pilot Study Examining the Use of Soy Isoflavones in the Prevention of Menstrually-Associated Migraine|
|Study Start Date :||May 2003|
|Study Completion Date :||March 2005|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00203255
|United States, Pennsylvania|
|Jefferson Headache Center|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Stephen D. Silberstein, M.D.||Thomas Jefferson University, Jefferson Headache Center|