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Sponsors and Collaborators: |
National Center for Research Resources (NCRR) University of Texas |
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Information provided by: | National Center for Research Resources (NCRR) |
ClinicalTrials.gov Identifier: | NCT00004330 |
OBJECTIVES:
Assess whether chronic administration of gonadotropin-releasing hormone analogues is safe and effective for the prevention of cyclic attacks of acute porphyria in women.
Condition | Intervention |
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Porphyria |
Drug: luteinizing hormone-releasing factor |
Study Type: | Interventional |
Study Design: | Prevention |
Study Start Date: | March 1987 |
PROTOCOL OUTLINE: All patients receive a gonadotropin-releasing hormone (GnRH) analogue. Treatment begins on days 1 to 3 of a menstrual cycle.
Low-dose estrogen begins at approximately 3 months. All patients must have a daily calcium intake of at least 1 gram; supplements are allowed.
Patients are followed for at least 1 year.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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
Study ID Numbers: | 199/11885, UTMB-445, UTMB-312 |
Study First Received: | October 18, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004330 History of Changes |
Health Authority: | United States: Federal Government |
inborn errors of metabolism porphyria rare disease |
Metabolic Diseases Porphyrias Skin Diseases Hormone Antagonists Rare Diseases Hormones, Hormone Substitutes, and Hormone Antagonists Porphyria, Congenital Erythropoietic |
Hormones Metabolism, Inborn Errors Genetic Diseases, Inborn Porphyria, Erythropoietic Porphyria Skin Diseases, Genetic Metabolic Disorder |
Metabolism, Inborn Errors Metabolic Diseases Skin Diseases Genetic Diseases, Inborn Porphyrias Skin Diseases, Metabolic |
Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Porphyria, Erythropoietic Hormones Skin Diseases, Genetic Pharmacologic Actions |