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NCT01187524 · ClinicalTrials.gov registry record
The Natural History of Reproductive and Overall Health in Girls and Women With a Pre-Mutation in the FMR1 Gene; Creation of a Patient Registry
A clinical trial, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Terminated
- Registry status
- 7
- Enrollment target
NCT01187524 is a clinical trial that was terminated before completion, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 7 participants.
The verdict
NCT01187524 was terminated before completion, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- TERMINATED
- Registry status
- 7 participants
- Enrollment target
Study Summary
Background: * In human DNA, the Fragile X (FMR1) gene helps to regulate the nervous and reproductive systems. If the gene is abnormal, it can cause different kinds of problems, such as abnormal menstrual periods, decreased fertility, muscle tremors, and mental retardation. An abnormal FMR1 gene can also make a person more susceptible to other medical conditions, such as thyroid problems, high blood pressure, seizures, and depression. More research is needed on how abnormalities in the FMR1 gene can lead to these problems, and how often these problems appear in individuals with an abnormal FMR1 gene. * Researchers are interested in developing a patient registry of women who have an abnormality in the FMR1 gene. This registry will allow researchers to follow participants over time and study possible effects of this abnormality on their general and reproductive health. Objectives: \- To develop a patient registry of women with an abnormal FMR1 gene and monitor their general and reproductive health. Eligibility: \- Women at least 18 years of age who have an abnormal FMR1 gene on the X chromosome. Design: * The following groups of women will be eligible for screening for this study: * Those who have a family member with Fragile X Syndrome or mental retardation * Those who have (or have a family member who has) primary ovarian insufficiency, also known as premature menopause * Those who have (or have a family member who has) certain neurological problems such as tremors or Parkinson's disease. * Eligible participants will be scheduled for an initial study visit at the National Institutes of Health Clinical Center. Participants who have regular menstrual periods should schedule the visit between days 3 and 8 of the menstrual cycle; those who do not have regular periods may have the visit at any time of the month. In addition, all estrogen-based treatments (such as birth control pills) must be stopped for 2 weeks prior to the study visit. * Participants will have a f
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2010-08-05 |
| Est. Completion | 2013-05-31 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01187524
The ClinicalTrials.gov registry entry for NCT01187524 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT01187524 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01187524 about?
NCT01187524 is a clinical study titled "The Natural History of Reproductive and Overall Health in Girls and Women With a Pre-Mutation in the FMR1 Gene; Creation of a Patient Registry". Background: * In human DNA, the Fragile X (FMR1) gene helps to regulate the nervous and reproductive systems. If the gene is abnormal, it can cause different kinds of problems, such as abnormal menstrual periods, decreased fertility, muscle tremors, and mental retardation. An abnormal FMR1 gene can...
What is the current status of trial NCT01187524?
This trial is currently terminated. The enrollment target is 7 participants. The study started on 2010-08-05. Estimated completion is 2013-05-31.
Who is sponsoring clinical trial NCT01187524?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
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