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NCT00700128 · ClinicalTrials.gov registry record · NA

Prevention of Menstrual Migraines: Using Frovatriptan or Placebo During Hormone Free Intervals

A NA study, sponsored by Scott and White Hospital & Clinic.

Completed
Registry status
NA
Development phase
30
Enrollment target

NCT00700128: Completed NA study, sponsored by Scott and White Hospital & Clinic.

NCT00700128 is a NA study that has completed, run by Scott and White Hospital & Clinic. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00700128, a NA study, has completed, sponsored by Scott and White Hospital & Clinic.

COMPLETED
Registry status
NA
Development phase
30 participants
Enrollment target

Study Summary

This study will examine the combined effects of a continuous oral contraceptive (OC) regimen with supplemental frovatriptan therapy on headache severity and occurrence in subjects with documented Menstrually Associated Migraines (MAM). 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 prophylactic administration of a triptan 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 triptan or placebo groups. The purpose of this research study is to examine the effects of continuous oral contraceptive pills and frovatriptan 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 look if taking frovatriptan around the time of the period will affect the headache, and how it will be affected. Frovatriptan is an FDA approved drug for migraine headaches. This study is a prospective pilot trial.The study will last approximately 35-39 weeks.

Interventions

  • DRUG placebo
  • DRUG frovatriptan

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2008-06
Est. Completion 2010-01
Phase NA

What the finished NCT00700128 record still lists

NCT00700128 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.

NCT00700128 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00700128 about?

NCT00700128 is a clinical study titled "Prevention of Menstrual Migraines: Using Frovatriptan or Placebo During Hormone Free Intervals". This study will examine the combined effects of a continuous oral contraceptive (OC) regimen with supplemental frovatriptan therapy on headache severity and occurrence in subjects with documented Menstrually Associated Migraines (MAM). The subjects enrolling in the study will have cyclic menses eith...

What is the current status of trial NCT00700128?

This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2008-06. Estimated completion is 2010-01.

What interventions are being tested in trial NCT00700128?

The interventions under investigation include: placebo (DRUG), frovatriptan (DRUG).

Who is sponsoring clinical trial NCT00700128?

This trial is sponsored by Scott and White Hospital & Clinic, which has 9 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00700128's enrollment target sits among peer trials

30 1593rd of 2000 higher than 299 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00700128, the US trial registry maintained by the National Library of Medicine. NCT00700128 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.