Prevention of Menstrual Migraines: Effects of Estrogen Add-back During the HFI in Patients Using Continuous Oral Contraceptives.

NCT01251263 | Unknown Phase 4

• 1 other identifier: 90304
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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). 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

Keywords

headaches; migraines; breakthrough bleeding; breakthrough spotting; menstrually associated migraines; breakthrough bleeding or breakthrough spotting

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measure

  Comparing baseline menstrually associated migraines(MAMs) to headache occurance and severity after the implementation of continuous OC therapy.

  32 weeks

Secondary Outcomes (1)

• Secondary Outcome Measure

  32 weeks

Study Arms (2)

Group 1

OTHER

Cyclic OC users prior to initiating study OC. Estradiol or placebo given in a certain sequence depending on the randomization.

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.

Drug: Estradiol or Placebo

Interventions

Estradiol or Placebo DRUG

Estradiol 1mg twice daily or placebo starting on the last day of OC and continuing during the HFI (total of 9 doses).

Group 1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Scott and White Hospital & Clinic: lead

Study Sites (1)

Scott and White Hospital & Clinic

Temple, Texas, 76508, United States

RECRUITING

MeSH Terms

Conditions

Metrorrhagia; Headache; Migraine Disorders

Interventions

Estradiol

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Patricia J Sulak, MD

  Scott and White Healthcare

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wendy M White, CCRP

CONTACT

254-724-8301; wewhite@swmail.sw.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 30, 2010
• First Posted: December 1, 2010
• Study Start: October 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: December 1, 2010

Record last verified: 2010-10

Locations

US (1)