Menstrual MigrainesPhase 4Estradiol/MAMNCT01251263
Prevention of Menstrual Migraines: Effects of Estrogen Add-back During the HFI in Patients Using Continuous Oral Contraceptives.
A Phase 4 study of Menstrual Migraines and Menstrual Bleeding, run by Scott and White Hospital & Clinic at 1 site in United States.
Trial summary
This study will examine the combined effects of a continuous oral contraceptive (OC) regimen with supplemental estradiol therapy on headache severity and occurrence in subjects with documented Menstrually Associated Migraines (MAMs). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Migraines, Menstrual Bleeding, Menstrual Spotting
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Oct 2012
- Phase
- Phase 4
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women may be on birth control pill (OC), patch or vaginal ring taken in the traditional 21/7 or 24/4 manner, which means that every month they have a period. If they are taking it continuously (without a period), you must be willing to take your birth control 21/7 for 2 months.
- If you are not on OC's, patch or vaginal ring you must have a period every 21-40 days.
- You must not want to get pregnant for 12 months.
- Women who have headaches around the time of their period.
Who cannot join
- BMI >38
- If you smoke and are age 35 years old or greater or if you are under 35 years old and smoke over 10 cigarettes a day.
- If you have or had an aura with your headaches. (An aura is a temporary sensation, like bright lights that come before you experience the headache)
- Headaches are not occuring during the time of your period.
- Blood Pressure > 140/90 or you take more than a single antihypertensive medication (excluding diuretics) and are age 40 or greater.
- Contraindications to combination estrogen/progestin hormonal contraceptives.
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- Desire to become pregnant in the next 12 months.
- Stroke
- Breast Cancer
- Blood clots in your legs, lung or anywhere else in your body.
- Diabetes Mellitus
- Heart Attack
- Liver Disease
- Systemic Lupus Erythematosus
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Scott and White Hospital & Clinic
Temple, Texas, 76508
Patricia J Sulak, MD
About this study
This study will examine the combined effects of a continuous oral contraceptive (OC) regimen with supplemental estradiol therapy on headache severity and occurrence in subjects with documented Menstrually Associated Migraines (MAMs). The subjects enrolling in the study will have cyclic menses either due to spontaneous ovulation or use of cyclic hormonal contraception (pill, patch, or ring). Enrolled subjects will start a continuous OC regimen following two baseline menstrual cycles. If breakthrough bleeding/spotting (BTB/BTS) occurs, the subject will institute a 4-day hormone-free interval (HFI). In an attempt to prevent/lessen the severity of headache during the HFI, subjects will be randomized to oral estradiol or placebo during this period. If no BTB/BTS occurs after 80 days of continuous pills, the subject will institute a 4-day HFI during which they will be randomized into estradiol or placebo groups.
The purpose of this research study is to examine the effects of continuous oral contraceptive pills and oral estradiol on headaches that occur around the time of your period. Many woman take continuous oral contraceptive pills (OC) and when OCs are stopped they may get headaches. This study will examine if taking estradiol around the time of the period will affect the headache, and how it will be affected.
This study is a prospective trial. A subject's participation will last approximately 32 weeks.
- Conditions
- Menstrual Migraines, Menstrual Bleeding, Menstrual Spotting
- Being tested
- Estradiol or Placebo
- Keywords
- headaches, migraines, breakthrough bleeding, breakthrough spotting, menstrually associated migraines, breakthrough bleeding or breakthrough spotting
- Medical subject headings
- Metrorrhagia, Headache, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol or PlaceboDrug
Estradiol 1mg twice daily or placebo starting on the last day of OC and continuing during the HFI (total of 9 doses).
Estradiol or PlaceboDrug
Estradiol 1mg will be taken twice daily starting with the last day of pills and the 4 days of the HFI(total of 9 doses)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Cyclic OC users prior to initiating study OC. Estradiol or placebo given in a certain sequence depending on the randomization. Receives: Drug: Estradiol or Placebo |
| Group 2 | Other | Spontaneous ovulation group prior to initiating study OC. Estradiol or placebo given in a certain sequence depending on the randomization. Receives: Drug: Estradiol or Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
Comparing baseline menstrually associated migraines(MAMs) to headache occurance and severity after the implementation of continuous OC therapy.
Measured: 32 weeks
Secondary outcomes (1)
Secondary Outcome Measure
Compare effect of estradiol versus placebo on MAMs severity and duration.
Measured: 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual MigrainesStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scott and White Hospital & Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Patricia J Sulak, MD, Principal investigator, Scott and White Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01251263
- Sponsor's protocol ID
- 90304
- Acronym
- Estradiol/MAM
- Status last verified
- Oct 2010
- First submitted
- 30 Nov 2010
- Last updated
- 1 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Menstrual Migraines: Effects of Estrogen Add-back During the HFI in Patients Using Continuous Oral Contraceptives.
- ClinicalTrials.gov ID
- NCT01251263
- Acronym / sponsor ID
- Estradiol/MAM / 90304
- Conditions
- Menstrual Migraines, Menstrual Bleeding, Menstrual Spotting
- Keywords
- headaches, migraines, breakthrough bleeding, breakthrough spotting, menstrually associated migraines, breakthrough bleeding or breakthrough spotting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Scott and White Hospital & ClinicUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 1 Dec 2010 (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.
This study will examine the combined effects of a continuous oral contraceptive (OC) regimen with supplemental estradiol therapy on headache severity and occurrence in subjects with documented Menstrually Associated Migraines (MAMs). The subjects enrolling in the study will have cyclic menses either due to spontaneous ovulation or use of cyclic hormonal contraception (pill, patch, or ring). Enrolled subjects will start a continuous OC regimen following two baseline menstrual cycles. If breakthrough bleeding/spotting (BTB/BTS) occurs, the subject will institute a 4-day hormone-free interval (HFI). In an attempt to prevent/lessen the severity of headache during the HFI, subjects will be randomized to oral estradiol or placebo during this period. If no BTB/BTS occurs after 80 days of continuous pills, the subject will institute a 4-day HFI during which they will be randomized into estradiol or placebo groups.
The purpose of this research study is to examine the effects of continuous oral contraceptive pills and oral estradiol on headaches that occur around the time of your period. Many woman take continuous oral contraceptive pills (OC) and when OCs are stopped they may get headaches. This study will examine if taking estradiol around the time of the period will affect the headache, and how it will be affected.
This study is a prospective trial. A subject's participation will last approximately 32 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Drug: Estradiol or PlaceboCyclic OC users prior to initiating study OC. Estradiol or placebo given in a certain sequence depending on the randomization. |
| Group 2 | Other | Drug: Estradiol or PlaceboSpontaneous ovulation group prior to initiating study OC. Estradiol or placebo given in a certain sequence depending on the randomization. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women may be on birth control pill (OC), patch or vaginal ring taken in the traditional 21/7 or 24/4 manner, which means that every month they have a period. If they are taking it continuously (without a period), you must be willing to take your birth control 21/7 for 2 months.
- If you are not on OC's, patch or vaginal ring you must have a period every 21-40 days.
- You must not want to get pregnant for 12 months.
- Women who have headaches around the time of their period.
Key exclusion criteria (14 listed)
- BMI >38
- If you smoke and are age 35 years old or greater or if you are under 35 years old and smoke over 10 cigarettes a day.
- If you have or had an aura with your headaches. (An aura is a temporary sensation, like bright lights that come before you experience the headache)
- Headaches are not occuring during the time of your period.
- Blood Pressure > 140/90 or you take more than a single antihypertensive medication (excluding diuretics) and are age 40 or greater.
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 |
|---|---|---|
| Estradiol or PlaceboEstradiol 1mg twice daily or placebo starting on the last day of OC and continuing during the HFI (total of 9 doses). | Drug | Group 1 |
| Estradiol or PlaceboEstradiol 1mg will be taken twice daily starting with the last day of pills and the 4 days of the HFI(total of 9 doses) | Drug | Group 2 |
Primary outcome
Primary Outcome Measure
Time frame: 32 weeks
Comparing baseline menstrually associated migraines(MAMs) to headache occurance and severity after the implementation of continuous OC therapy.
1 secondary outcome
Secondary Outcome Measure
Time frame: 32 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2010.
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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.
Patricia J Sulak, MD principal investigator
Scott and White Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Menstrual Migraines and Menstrual Bleeding, run by Scott and White Hospital & Clinic 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 4 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 1 Dec 2010. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wendy M White, CCRP (254-724-8301, wewhite@swmail.sw.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure (time frame: 32 weeks). 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 1 Dec 2010.