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

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.

Study Overview

• Status: Completed
• Conditions: Porphyria
• Intervention / Treatment: Drug: luteinizing hormone-releasing factor

Detailed Description

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555-0209
      • University of Texas Medical Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention

Collaborators and Investigators

• Sponsor: National Center for Research Resources (NCRR)
• Collaborators: University of Texas
• Investigators: Study Chair: Karl E Anderson, University of Texas

Study record dates

Study Major Dates

• Study Start: March 1, 1987

Study Registration Dates

• First Submitted: October 18, 1999
• First Submitted That Met QC Criteria: October 18, 1999
• First Posted (Estimate): October 19, 1999

Study Record Updates

• Last Update Posted (Estimate): June 24, 2005
• Last Update Submitted That Met QC Criteria: June 23, 2005
• Last Verified: December 1, 2003

More Information

Terms related to this study

• Keywords: rare disease; inborn errors of metabolism; porphyria
• Additional Relevant MeSH Terms: Metabolic Diseases; Skin Diseases; Genetic Diseases, Inborn; Skin Diseases, Genetic; Porphyria, Erythropoietic; Porphyrias; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormones
• Other Study ID Numbers: 199/11885; UTMB-445; UTMB-312