Evaluation of Women With Endocrine and Reproductive-Related Conditions
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ClinicalTrials.gov Identifier: NCT00001850 |
Recruitment Status :
Recruiting
First Posted : November 4, 1999
Last Update Posted : December 11, 2020
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Tracking Information | |||||||||
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First Submitted Date | November 3, 1999 | ||||||||
First Posted Date | November 4, 1999 | ||||||||
Last Update Posted Date | December 11, 2020 | ||||||||
Actual Study Start Date | May 10, 1999 | ||||||||
Primary Completion Date | Not Provided | ||||||||
Current Primary Outcome Measures |
To provide a mechanism for reproductive endocrine fellows and staff to evaluate woman with medical conditions of interest for fellow training and clinical training and education. [ Time Frame: 11/30/2025 ] To provide a mechanism for reproductive endocrine fellows and staff to evaluate woman with medical conditions of interest for fellow training and clinical training and education.
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Original Primary Outcome Measures | Not Provided | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures | Not Provided | ||||||||
Original Secondary Outcome Measures | Not Provided | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title | Evaluation of Women With Endocrine and Reproductive-Related Conditions | ||||||||
Official Title | Evaluation of Women and Men With Endocrine and Reproductive-Related Conditions | ||||||||
Brief Summary | This study was designed to allow inpatient and outpatient evaluation of women with a variety of reproductive and endocrine-related disorders for purposes of research and physician education. The evaluations may include ultrasound examinations, blood, saliva, and/or urine samples. In some cases, specific laboratory or X-ray studies will be performed to confirm the diagnosis or assist in the treatment of the patient. These additional tests will be conducted within the guidelines of current gynecologic practice. In some cases, the patient will receive medical or surgical treatment for their disorder. The purpose of this study is to provide an opportunity for physicians to evaluate women with medical conditions of reproduction. These evaluations and treatments will support clinical training and research for the accredited training program in reproductive endocrinology at the National Institute of Child Health and Human Development (NICHD).<TAB> |
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Detailed Description | This protocol is designed to allow inpatient and outpatient evaluation of women with a variety of reproductive and endocrine-related disorders for purposes of research and physician education in our accredited reproductive endocrine training program. The evaluations may include ultrasound examinations and the collection of blood, saliva, and/or urine samples. In some cases, laboratory or radiologic studies will be performed to confirm the diagnosis or to aid in the management of the patient, as would be done in current gynecologic practice. In some cases, the patient will receive medical or surgical treatment for their disorder. The purpose of these evaluations or treatments will be to support our clinical training and/or research mission. In particular, this protocol is intended to provide a mechanism for reproductive endocrine fellows and staff to evaluate women with medical conditions of interest for fellow teaching and clinical training. | ||||||||
Study Type | Observational | ||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||||
Biospecimen | Not Provided | ||||||||
Sampling Method | Non-Probability Sample | ||||||||
Study Population | Patients aged 1-85 with reproductive disorders | ||||||||
Condition |
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Intervention | Not Provided | ||||||||
Study Groups/Cohorts |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment |
900 | ||||||||
Original Enrollment |
150 | ||||||||
Study Completion Date | Not Provided | ||||||||
Primary Completion Date | Not Provided | ||||||||
Eligibility Criteria |
Exclusion Criteria:
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Sex/Gender |
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Ages | 1 Year to 85 Years (Child, Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers | Yes | ||||||||
Contacts |
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Listed Location Countries | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT00001850 | ||||||||
Other Study ID Numbers | 990103 99-CH-0103 |
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Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||
IPD Sharing Statement | Not Provided | ||||||||
Responsible Party | National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) ) | ||||||||
Study Sponsor | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||||||
Collaborators | Not Provided | ||||||||
Investigators |
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PRS Account | National Institutes of Health Clinical Center (CC) | ||||||||
Verification Date | January 28, 2020 |