Clinical Study Examining Use of an Over-the-Counter Supplement for the Prevention of Menstrually-Associated Migraine Headache
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||An Open-Label, Pilot Study Examining the Use of Soy Isoflavones in the Prevention of Menstrually-Associated Migraine|
- 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
|Study Start Date:||May 2003|
|Estimated Study Completion Date:||March 2005|
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.
|United States, Pennsylvania|
|Jefferson Headache Center|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Stephen D. Silberstein, M.D.||Thomas Jefferson University, Jefferson Headache Center|