A Multicenter Study to Evaluate the Efficacy of a 91-Day Extended Cycle Oral Contraceptive for Menstrually-Related Migraine Headaches
A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy of DR-105 Compared to Placebo For the Management of Menstrually-Related Migraine Headaches.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
-
-
California
-
La Mesa, California, Vereinigte Staaten, 91942
- Teva Investigational Site
-
San Diego, California, Vereinigte Staaten, 92108
- Duramed Investigational Site
-
San Diego, California, Vereinigte Staaten, 92123
- Teva Investigational Site
-
San Francisco, California, Vereinigte Staaten, 94109-4841
- Duramed Investigational Site
-
-
District of Columbia
-
Washington, District of Columbia, Vereinigte Staaten, 20036
- Duramed Investigational Site
-
-
Florida
-
West Palm Beach, Florida, Vereinigte Staaten, 33409
- Duramed Investigational Site
-
-
Georgia
-
Savannah, Georgia, Vereinigte Staaten, 31406
- Teva Investigational Site
-
-
New Jersey
-
Edison, New Jersey, Vereinigte Staaten, 08817
- Duramed Investigational Site
-
-
New York
-
New York, New York, Vereinigte Staaten, 10022
- Duramed Investigational Site
-
-
North Carolina
-
Winston-Salem, North Carolina, Vereinigte Staaten, 27103
- Teva Investigational Site
-
-
Oklahoma
-
Tulsa, Oklahoma, Vereinigte Staaten, 74105
- Teva Investigational Site
-
-
Oregon
-
Medford, Oregon, Vereinigte Staaten, 97504
- Teva Investigational Site
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Vereinigte Staaten, 19114
- Duramed Investigational Site
-
Uniontown, Pennsylvania, Vereinigte Staaten, 15401
- Teva Investigational Site
-
-
South Carolina
-
Columbia, South Carolina, Vereinigte Staaten, 29201
- Teva Investigational Site
-
Hilton Head, South Carolina, Vereinigte Staaten, 29926
- Teva Investigational Site
-
-
Tennessee
-
Memphis, Tennessee, Vereinigte Staaten, 38120
- Teva Investigational Site
-
-
Texas
-
Dallas, Texas, Vereinigte Staaten, 75234
- Duramed Investigational Site
-
Houston, Texas, Vereinigte Staaten, 77054
- Teva Investigational Site
-
San Antonio, Texas, Vereinigte Staaten, 78258
- Duramed Investigational Site
-
-
Virginia
-
Virginia Beach, Virginia, Vereinigte Staaten, 23454
- Duramed Investigational Site
-
-
Washington
-
Seattle, Washington, Vereinigte Staaten, 98105
- Duramed Investigational Site
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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-Tage-Kur bestehend aus 84 blauen Kombinationstabletten mit 150 µg LNG/30 µg EE und 7 gelben Tabletten mit 10 µg EE.
Andere Namen:
|
|
Placebo-Komparator: 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
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Percentage of Participants With ≥ 50% Reduction in Migraine Frequency During the Treatment Period
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Percentage of Participants With ≥ 50% Reduction in Migraine Frequency During the First, Second and Third Months
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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:
|
Baseline and Week 15
|
|
Change From Baseline in Headache Impact Test
Zeitfenster: 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)
Zeitfenster: 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:
|
Up to 15 weeks
|
|
Mean Number of Days of Bleeding or Spotting
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Gehirns
- Erkrankungen des zentralen Nervensystems
- Erkrankungen des Nervensystems
- Schmerzen
- Neurologische Manifestationen
- Kopfschmerzerkrankungen, primär
- Kopfschmerzen
- Migräneerkrankungen
- Kopfschmerzen
- Physiologische Wirkungen von Arzneimitteln
- Verhütungsmittel, hormonell
- Reproduktionskontrollmittel
- Verhütungsmittel, weiblich
- Verhütungsmittel, oral, synthetisch
- Levonorgestrel
- Verhütungsmittel
- Kontrazeptiva, oral
Andere Studien-ID-Nummern
- DR-105-201
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .