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A Multicenter Study to Evaluate the Efficacy of a 91-Day Extended Cycle Oral Contraceptive for Menstrually-Related Migraine Headaches

12 december 2016 uppdaterad av: Duramed Research

A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy of DR-105 Compared to Placebo For the Management of Menstrually-Related Migraine Headaches.

This study is being conducted to evaluate the efficacy of a 91-day extended cycle oral contraceptive compared to placebo for decreasing the frequency and severity of menstrually-related migraine headaches.

Studieöversikt

Studietyp

Interventionell

Inskrivning (Faktisk)

109

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • California
      • La Mesa, California, Förenta staterna, 91942
        • Teva Investigational Site
      • San Diego, California, Förenta staterna, 92108
        • Duramed Investigational Site
      • San Diego, California, Förenta staterna, 92123
        • Teva Investigational Site
      • San Francisco, California, Förenta staterna, 94109-4841
        • Duramed Investigational Site
    • District of Columbia
      • Washington, District of Columbia, Förenta staterna, 20036
        • Duramed Investigational Site
    • Florida
      • West Palm Beach, Florida, Förenta staterna, 33409
        • Duramed Investigational Site
    • Georgia
      • Savannah, Georgia, Förenta staterna, 31406
        • Teva Investigational Site
    • New Jersey
      • Edison, New Jersey, Förenta staterna, 08817
        • Duramed Investigational Site
    • New York
      • New York, New York, Förenta staterna, 10022
        • Duramed Investigational Site
    • North Carolina
      • Winston-Salem, North Carolina, Förenta staterna, 27103
        • Teva Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, Förenta staterna, 74105
        • Teva Investigational Site
    • Oregon
      • Medford, Oregon, Förenta staterna, 97504
        • Teva Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Förenta staterna, 19114
        • Duramed Investigational Site
      • Uniontown, Pennsylvania, Förenta staterna, 15401
        • Teva Investigational Site
    • South Carolina
      • Columbia, South Carolina, Förenta staterna, 29201
        • Teva Investigational Site
      • Hilton Head, South Carolina, Förenta staterna, 29926
        • Teva Investigational Site
    • Tennessee
      • Memphis, Tennessee, Förenta staterna, 38120
        • Teva Investigational Site
    • Texas
      • Dallas, Texas, Förenta staterna, 75234
        • Duramed Investigational Site
      • Houston, Texas, Förenta staterna, 77054
        • Teva Investigational Site
      • San Antonio, Texas, Förenta staterna, 78258
        • Duramed Investigational Site
    • Virginia
      • Virginia Beach, Virginia, Förenta staterna, 23454
        • Duramed Investigational Site
    • Washington
      • Seattle, Washington, Förenta staterna, 98105
        • Duramed Investigational Site

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 34 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

Inclusion Criteria:

  • Premenopausal, non-pregnant, non-lactating
  • History of migraine headaches without aura for at least 6 months
  • History of migraine headaches associated with menstruation
  • Others as directed by FDA-approved protocol

Exclusion Criteria:

  • History of migraine headaches with aura or focal neurological symptoms
  • Any contraindication to the use of oral contraceptives
  • Others as dictated by FDA-approved protocol

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 91-day Levonorgestrel Oral Contraceptive
Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
91 dagars behandling bestående av 84 blå kombinationstabletter innehållande 150 µg LNG/30 µg EE och 7 gula tabletter innehållande 10 µg EE.
Andra namn:
  • Seasonique
  • DR-105
Placebo-jämförare: Placebo
Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
1 tablet daily to match experimental arm

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Participants With ≥ 50% Reduction in Migraine Frequency During the Treatment Period
Tidsram: Baseline (25-35 days before Day 1) and Days 1-91
The number of participants with at least 50% reduction in migraine frequency (average weekly number of migraine episodes) through the end of the 91-day treatment period compared with Baseline (the 25- to 35-day baseline qualification period). Participants recorded the incidence, timing and intensity of migraines in a migraine diary during the prequalification period and throughout the 91-day treatment period.
Baseline (25-35 days before Day 1) and Days 1-91

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Participants With ≥ 50% Reduction in Migraine Frequency During the First, Second and Third Months
Tidsram: Baseline, Month1, Month 2 and Month 3
The percentage of participants with at least 50% reduction in migraine frequency (average weekly number of migraine episodes) compared to Baseline at each month of the treatment period.
Baseline, Month1, Month 2 and Month 3
Change From Baseline in Average Migraine Severity
Tidsram: Baseline and Month 1, Month 2 and Month 3

Migraine severity was recorded by participants in the Baseline qualification diary and study migraine diary during the treatment period. Participants could report a severity of none (score = 0), mild (1), moderate (2), or severe (3). In general, if a headache was mild, daily activities could be resumed and little to no medication was taken. Moderate headaches required medication and effected daily activities. Severe headaches were debilitating and required medication.

Average migraine severity is defined as the sum of the severity ratings divided by the total number of migraine episodes reported during the observation period (for example, Baseline, First Month, Second Month, Third Month, and 91-Day Treatment Period). A negative change from Baseline score indicates improvement in severity.

Baseline and Month 1, Month 2 and Month 3
Percentage of Participants Who Required Rescue Medications During the Study Period
Tidsram: Baseline, Month 1, Month 2 and Month 3
Participants recorded use of rescue medications for migraines in the migraine diary during the course of study treatment.
Baseline, Month 1, Month 2 and Month 3
Change From Baseline in Migraine Disability Assessment
Tidsram: Baseline and Week 15

The migraine disability assessment (MIDAS) test is used to determine how severely migraines affect a patient's life. Participants were asked five questions about how often their headaches limited their ability to go to work or school, to do household work or to do family or leisure activities in the past 3 months.

The MIDAS score equals the sum of the days answered for each question and ranges from 0 (no disability) to approximately 270 (severe disability; the upper bound is dependent on the number of days a participant would plan to work or participate in other activities).

The MIDAS score is classified into four grades of severity:

  • 0 to 5: MIDAS Grade I, Little or no disability
  • 6 to 10: MIDAS Grade II, Mild disability
  • 11 to 20: MIDAS Grade III, Moderate disability
  • 21+: MIDAS Grade IV, Severe disability
Baseline and Week 15
Change From Baseline in Headache Impact Test
Tidsram: Baseline and Week 15

The Headache Impact Test (HIT) is a tool used to measure the impact headaches have on patients' ability to function on the job, at school, at home and in social situations.

HIT-6 consists of 6 questions each scored on a scale from Never (6 points) to Always (13 points). The total score ranges from 36 to 78 with higher scores indicating greater impact on life.

There was an error in administration of the HIT-6 in this study. Question 6 was not administered, and question 3 from the MIDAS was included instead. Therefore, the total score of the HIT-6 could not be calculated.

Baseline and Week 15
Number of Participants With Adverse Events (AEs)
Tidsram: Up to 15 weeks

An AE is any untoward medical occurrence in a clinical investigation participant and which does not necessarily have to have a causal relationship with this treatment or clinical study.

The following definitions were used to assess AE severity: Mild: Awareness of signs or symptoms, but they are easily tolerated; Moderate: Enough discomfort to cause interference with usual activity; Severe: Incapacitating, with inability to perform usual activity.

Relationship to study drug was assessed as either: None: Causal relationship can be ruled out; Possibly: Causal relationship at least reasonably possible, i.e. relationship cannot be ruled out; Definitely: Causal relationship is certain.

A serious adverse event (SAE) is one that met any one of the following criteria:

  • Fatal or life threatening
  • Requires or prolongs in patient hospitalization
  • Results in persistent or significant disability/incapacity
  • Congenital anomaly / birth defect
  • Important medical event.
Up to 15 weeks
Mean Number of Days of Bleeding or Spotting
Tidsram: 91-day treatment period
Bleeding and spotting were recorded by participants in the migraine diary during the 91-day treatment period.
91-day treatment period

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 januari 2009

Primärt slutförande (Faktisk)

1 augusti 2011

Avslutad studie (Faktisk)

1 augusti 2011

Studieregistreringsdatum

Först inskickad

28 oktober 2008

Först inskickad som uppfyllde QC-kriterierna

28 oktober 2008

Första postat (Uppskatta)

29 oktober 2008

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

6 februari 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

12 december 2016

Senast verifierad

1 december 2016

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på 91-dagars Levonorgestrel oralt preventivmedel

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Prenumerera