Endocrine Disorders of Female Reproductive SystemNCT02429336
Characteristics of Women With Reproductive Concerns
An observational study of Endocrine Disorders of Female Reproductive System, run by University of Tennessee at 1 site in United States.
Trial summary
The purpose of this study is to collect data that will be generated during an office visit. The data will be gathered and analyzed in research studies that will help with the investigators understanding of various medical conditions. About 200 subjects will be participating in this study. Read more about this study
- Who is it for?
- Ages 8 years and older, women only
- Conditions the study is for
- Endocrine Disorders of Female Reproductive System
- How many people
- 194 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to 30 Jun 2020
- Phase
- Observational
- 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 8 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Population: All patients presenting to the reproductive endocrinology clinic.
Who may be able to join
- females of childbearing potential experiencing reproductive endocrinology related problems
Who cannot join
- male or female not of childbearing potential
Trial locations and contacts
1 site in 1 country.
United States1 site
Regional One Health Ob-Gyn Clinic
Memphis, Tennessee, 38103
About this study
Official title: Clinical Characteristics of Women Presenting to the Reproductive Endocrinology Clinic
The purpose of this study is to collect data that will be generated during an office visit. The data will be gathered and analyzed in research studies that will help with the investigators understanding of various medical conditions.
About 200 subjects will be participating in this study. Participation in this study will not require a patient's time or presence. The medical information contained in a patient's chart from the office visit, including the results of any tests that were ordered at that time, will be transferred to an anonymous database and analyzed together with data from other patients who have similar condition/s.
No follow-up information will be collected. The following information will be collected from a patient's medical record: the medical history and a list of the current medications.
Read the detailed description
Purpose: To collect the characteristics of patients presenting to the reproductive endocrinology clinic.
Rationale: Patients' characteristics will be analyzed as part of clinical research studies and may help in understanding the causes of their condition.
What is being measured
The primary outcome is the main question the study is designed to answer.
Data collection from patients' charts.
Data collection from patients' charts.
Measured: up to 1 year from the time of signing the informed consent for data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startJan 2012
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endocrine Disorders of Female Reproductive SystemStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Detti, M.D., Principal investigator, Associate Professor, UTennessee Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429336
- Sponsor's protocol ID
- 11-01368-XP
- Status last verified
- Nov 2020
- First submitted
- 23 Mar 2015
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics of Women Presenting to the Reproductive Endocrinology Clinic
- ClinicalTrials.gov ID
- NCT02429336
- Acronym / sponsor ID
- 11-01368-XP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 29 Apr 2015 (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.
The purpose of this study is to collect data that will be generated during an office visit. The data will be gathered and analyzed in research studies that will help with the investigators understanding of various medical conditions.
About 200 subjects will be participating in this study. Participation in this study will not require a patient's time or presence. The medical information contained in a patient's chart from the office visit, including the results of any tests that were ordered at that time, will be transferred to an anonymous database and analyzed together with data from other patients who have similar condition/s.
No follow-up information will be collected. The following information will be collected from a patient's medical record: the medical history and a list of the current medications.
Detailed description
Purpose: To collect the characteristics of patients presenting to the reproductive endocrinology clinic.
Rationale: Patients' characteristics will be analyzed as part of clinical research studies and may help in understanding the causes of their condition.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Population: All patients presenting to the reproductive endocrinology clinic.
Key inclusion criteria (1 listed)
- females of childbearing potential experiencing reproductive endocrinology related problems
Key exclusion criteria (1 listed)
- male or female not of childbearing potential
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Data collection from patients' charts.
Time frame: up to 1 year from the time of signing the informed consent for data collection
Data collection from patients' charts.
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 13 Nov 2020.
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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.
Laura Detti, M.D. principal investigator
Associate Professor, UTennessee Health Science Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endocrine Disorders of Female Reproductive System, run by University of Tennessee 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?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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 13 Nov 2020. 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.
What does the primary outcome measure?
Data collection from patients' charts. (time frame: up to 1 year from the time of signing the informed consent for data collection). It is what the study was designed to measure, not a finding.
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 13 Nov 2020.