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This trial is complete. It is no longer accepting participants.

NCT00004330

NCT00004330
Completed Not Applicable

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with one of these types of acute porphyria: Acute Intermittent Porphyria, Hereditary Coproporphyria, or Variegate Porphyria
  • Your porphyria attacks happen in a clear cycle, specifically during the second half of your menstrual cycle, with severe stomach pain and other porphyria symptoms
  • Your attacks completely go away within 5 days of your period starting, with no symptoms between attacks
  • You have had at least 4 to 6 attacks in the 6 months before joining the trial
  • More than half of your attacks are clearly different from period cramps or PMS, and have required hospital treatment (such as pain medication, IV fluids, or other treatments)
  • Any attacks that did not require hospitalization must have been similar in symptoms, just less severe
  • Your menstrual cycle has been between 25 and 35 days long for at least the past 6 months
  • You have had a normal pelvic exam within the last 60 days
  • You have had a normal smear test (no abnormal cells detected)
  • You have used an approved method of contraception for at least 2 months before joining, and are willing to continue throughout the study — OR you have had at least one menstrual cycle since having a tubal ligation (tubes tied)
  • Your pregnancy test is negative

Who may not be able to join:

  • You have had a life-threatening porphyria attack
  • You have cyclic stomach pain that is NOT caused by porphyria
  • You have used medication to stop ovulation within the last 6 months
  • You have no periods (amenorrhea) or any other menstrual abnormalities
  • You have any other gynaecological (reproductive health) abnormalities
  • You have a known allergy to gonadotropin-releasing hormone analogues (a type of hormone medication) (confirm with trial site)
  • Your recent lab (blood/urine) test results show significant abnormalities
  • You have a medical condition that would make the trial treatment unsafe for you (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Trial details

Status
Completed
Phase
Not Applicable
Sponsor
National Center for Research Resources (NCRR)
Registry
clinicaltrials_gov
Start date
1 March 1987

Where this trial is recruiting

🇺🇸 United States

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov