Migraine HeadacheNCT00203255
Clinical Study Examining Use of an Over-the-Counter Supplement for the Prevention of Menstrually-Associated Migraine Headache
A study testing Soy Isoflavones in people with Migraine Headache, run by Thomas Jefferson University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Migraine Headache
- What is being tested?
- Soy Isoflavones
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to Mar 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- •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
Who cannot join
- Subjects who are breastfeeding, pregnant or planning to become pregnant within the next 4 months. •Subjects who are currently on or have been on within three months prior to screening; hormonal contraceptives (oral, injection, or implants), hormone replacement therapy or any other hormone therapy including natural supplements. •Subjects who, in the investigators opinion, have a history or have evidence of a medical or psychiatric condition that would expose them to an increased risk of a significant adverse event or would interfere with the assessments of efficacy and tolerability during this trial •Subjects who experience greater than 15 headache days per month •Subjects who have an allergy to soy or soy based products. •Subjects with a history of significant drug or alcohol abuse within the past year
- Subjects who have participated in an investigational drug trial in the 30 days prior to the screening visit •Subjects who have breast cancer or who have a history of breast cancer.
Trial locations and contacts
1 site in 1 country.
United States1 site
Jefferson Headache Center
Philadelphia, Pennsylvania, 19107
About this study
Official title: An Open-Label, Pilot Study Examining the Use of Soy Isoflavones in the Prevention of Menstrually-Associated Migraine
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.
Read the detailed description
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.
- Conditions
- Migraine Headache
- Being tested
- Soy Isoflavones
- Keywords
- Menstrually-Associated Migraine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soy IsoflavonesDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Secondary outcomes (12)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMay 2003
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine HeadacheStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Investigators
- Stephen D. Silberstein, M.D., Principal investigator, Thomas Jefferson University, Jefferson Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00203255
- Sponsor's protocol ID
- SDS/SOY/02
- Status last verified
- Jan 2009
- First submitted
- 13 Sep 2005
- Last updated
- 23 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Pilot Study Examining the Use of Soy Isoflavones in the Prevention of Menstrually-Associated Migraine
- ClinicalTrials.gov ID
- NCT00203255
- Acronym / sponsor ID
- SDS/SOY/02
- Conditions
- Migraine Headache
- Keywords
- Menstrually-Associated Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- May 2003
- Study completion
- Mar 2005
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- •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
Key exclusion criteria (2 listed)
- Subjects who are breastfeeding, pregnant or planning to become pregnant within the next 4 months. •Subjects who are currently on or have been on within three months prior to screening; hormonal contraceptives (oral, injection, or implants), hormone replacement therapy or any other hormone therapy including natural supplements. •Subjects who, in the investigators opinion, have a history or have evidence of a medical or psychiatric condition that would expose them to an increased risk of a significant adverse event or would interfere with the assessments of efficacy and tolerability during this trial •Subjects who experience greater than 15 headache days per month •Subjects who have an allergy to soy or soy based products. •Subjects with a history of significant drug or alcohol abuse within the past year
- Subjects who have participated in an investigational drug trial in the 30 days prior to the screening visit •Subjects who have breast cancer or who have a history of breast cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soy Isoflavones | Drug | – |
Primary outcome
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
12 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen D. Silberstein, M.D. principal investigator
Thomas Jefferson University, Jefferson Headache Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soy Isoflavones in people with Migraine Headache, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2009.