Studies in Porphyria IV: Gonadotropin-Releasing Hormone (GnRH) Analogues for Prevention of Cyclic Attacks

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00004330
• Date of registration: 18/10/1999
• Prospective Registration: No
• Primary sponsor: National Center for Research Resources (NCRR)
• Public title: Studies in Porphyria IV: Gonadotropin-Releasing Hormone (GnRH) Analogues for Prevention of Cyclic Attacks
• Date of first enrolment: March 1987
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00004330
• Study type: Interventional
• Study design: Primary Purpose: Prevention
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Karl E Anderson
• Affiliation: University of Texas

Key inclusion & exclusion criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Acute porphyria, i.e.: Acute intermittent porphyria Hereditary
coproporphyria Variegate porphyria Definite cyclic attacks with severe abdominal pain and
other porphyria symptoms during luteal phase of menstrual cycle only Attacks resolve
completely within 5 days of onset of menses, i.e., no symptoms between attacks At least 4
to 6 attacks during the 6 months prior to entry More than half of these attacks must meet
the following criteria: Readily distinguishable from menstrual cramps and premenstrual
syndrome Required hospitalization for narcotic analgesics, phenothiazines, hematin,
intravenous fluids, or other treatment Luteal attacks not requiring hospitalization must
be similar in symptoms and differ only in severity No life-threatening porphyria attacks
No cyclic abdominal pain unless caused by porphyria --Prior/Concurrent Therapy-- At least
6 months since ovulation suppression --Patient Characteristics-- Reproductive: Menstrual
cycle 25-35 days for at least 6 months prior to entry Pelvic exam normal within 60 days
prior to entry Pap smear normal, i.e., no dysplasia No amenorrhea No other menstrual
abnormality No other gynecologic abnormality Negative pregnancy test Medically approved
contraception required for 2 months prior to entry and throughout study OR at least 1
menstrual cycle following tubal ligation Other: No allergy to gonadotropin-releasing
hormone analogues No clinically significant abnormal laboratory test results No medical
contraindication to protocol treatment



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Porphyria

Intervention(s)

Drug: luteinizing hormone-releasing factor

Secondary ID(s)

UTMB-312

199/11885

UTMB-445

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Texas