Characteristics of Women With Reproductive Concerns | NCT02429336

Studies
Characteristics of Women With Reproductive Concerns

NCT02429336

Sponsor

University of Tennessee

Status

Completed

Last Update Posted

Nov 13, 2020Actual

Enrollment

194Actual

Phase

Not provided

Conditions

Endocrine Disorders of Female Reproductive System

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Jun 30, 2020Actual

Completion Date

Jun 30, 2020Actual

First Submitted Date

Mar 23, 2015

First Submission Date that Met QC Criteria

Apr 28, 2015

First Posted Date

Apr 29, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 11, 2020

Last Update Posted Date

Nov 13, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

194Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Data collection from patients' charts.	Data collection from patients' charts.	up to 1 year from the time of signing the informed consent for data collection

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

females of childbearing potential experiencing reproductive endocrinology related problems

Exclusion Criteria:

male or female not of childbearing potential

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Population: All patients presenting to the reproductive endocrinology clinic.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Laura Detti, M.D.	Associate Professor, UTennessee Health Science Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Regional One Health Ob-Gyn Clinic		Memphis	Tennessee	38103	United States