PorphyriaNCT00004330
Studies in Porphyria IV: Gonadotropin-Releasing Hormone (GnRH) Analogues for Prevention of Cyclic Attacks
A study testing luteinizing hormone-releasing factor in people with Porphyria, run by National Center for Research Resources (NCRR) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Porphyria
- What is being tested?
- luteinizing hormone-releasing factor
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Mar 1987to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555-0209
About this study
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.
Read the 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.
- Conditions
- Porphyria
- Being tested
- luteinizing hormone-releasing factor
- Keywords
- inborn errors of metabolism, porphyria, rare disease
- Medical subject headings
- Porphyrias, Metabolism, Inborn Errors, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
luteinizing hormone-releasing factorDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startMar 1987
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PorphyriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of Texas
- Investigators
- Karl E Anderson, Study chair, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004330
- Sponsor's protocol ID
- 199/11885
- Other IDs
- UTMB-445, UTMB-312
- Status last verified
- Dec 2003
- First submitted
- 18 Oct 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies in Porphyria IV: Gonadotropin-Releasing Hormone (GnRH) Analogues for Prevention of Cyclic Attacks
- ClinicalTrials.gov ID
- NCT00004330
- Acronym / sponsor ID
- 199/11885
- Conditions
- Porphyria
- Keywords
- inborn errors of metabolism, porphyria, rare disease
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- University of Texas
- Study start
- Mar 1987
- First posted
- 19 Oct 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| luteinizing hormone-releasing factor | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
Related trials for Porphyria
Enrolling by invitationPhase 2/3
HELIOS: Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Efficacy of DISC-1459 (Bitopertin) in Participants With EPP or XLP
Erythropoietic Protoporphyria
RecruitingObservational study
ELEVATE, a Registry of Patients With Acute Hepatic Porphyria (AHP)
Acute Hepatic Porphyria
Active, not recruitingObservational study
Evaluating the Prevalence of Acute Hepatic Porphyria in Postural Tachycardia Syndrome
Postural Orthostatic Tachycardia Syndrome, Acute Hepatic Porphyria
RecruitingPhase 2/3
A Study to Investigate PORT-77 Oral Dosing Compared With Placebo in Participants With Erythropoietic Protoporphyria (EPP) or X-linked Protoporphyria (XLP)
Erythropoietic Protoporphyria (EPP), X-Linked Protoporphyria (XLP)
RecruitingObservational study
Identification of Acute Intermittent Porphyria Modifying Genes
Acute Intermittent Porphyria (AIP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl E Anderson study chair
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing luteinizing hormone-releasing factor in people with Porphyria, run by National Center for Research Resources (NCRR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.