Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women with Heavy Menstrual Bleeding Associated with Uterine Fibroids Save

Date Added
June 27th, 2017
PRO Number
Pro00066040
Researcher
David Soper

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Keywords
Obstetrics and Gynecology
Summary

The purpose of this study is to look at the long term effects and safety of Premenopausal Women with Heavy Menstrual Bleeding Associated with Uterine Fibroids, who have already participated in the first study M12-815. Subjects will currently be enrolled in the first study.

Institution
MUSC
Recruitment Contact
Laura Columbo
843-792-0316
columbol@musc.edu

Prospective, Non-Interventional/Observational Registry of US Uterine Fibroids Patients (Capture-US) Save

Date Added
May 16th, 2017
PRO Number
Pro00065519
Researcher
David Soper

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Keywords
Obstetrics and Gynecology
Summary

This study is try to understand current patients with fibroids and there choices for management. We will follow women through their journey and obtain patient reported outcomes, through questionnaire's, following their current therapies for Uterine Fibroids, including symptoms, quality of life, work productivity impact, and satisfaction.

Institution
MUSC
Recruitment Contact
Jordyn DeMartino
843-792-0349
demartij@musc.edu

Chronic Hypertension and Pregnancy (CHAP) Project A Pragmatic Multicenter Randomized Trial Antihypertensive Therapy for Mild Chronic Hypertension during Pregnancy Save

Date Added
April 18th, 2017
PRO Number
Pro00063098
Researcher
Julio Mateus nino

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Keywords
Obstetrics and Gynecology
Summary

The purpose of this study is to evaluate the safety and benefits of treating mild chronic hypertension (CHTN), or high blood pressure, with medication during pregnancy vs non treatment. Medication prescribed is medication currently approved to treat severe CHTN.

Institution
MUSC
Recruitment Contact
Laura Columbo
843-792-0316
columbol@musc.edu

A Double-blind, Randomized, Controlled Trial Comparing the Safety and Efficacy of AMDC-USR with Placebo in Female Subjects with Stress Urinary Incontinence Save

Date Added
March 14th, 2017
PRO Number
Pro00061900
Researcher
Steven Swift

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Keywords
Obstetrics and Gynecology
Summary

The purpose of this study is to test how safe and effective using Muscle Derived Cells are at treating stress urinary incontinence. Muscled derived cells are normal immature cells found in all muscle, that when stimulated, can grow into normal mature muscle cells. These cells will be obtained from the thigh muscle of subjects via a biopsy and injected back into the subjects around the urethra to grow a new urethral sphincter. This will be done in patients suffering from stress urinary incontinence, which is felt to be due in part to a weak urethral sphincter.

Institution
MUSC
Recruitment Contact
Laura Columbo
843-792-0316
columbol@musc.edu

TREETOP: A Multicenter Assessment of a Spontaneous Preterm Birth Risk predictor Save

Date Added
August 23rd, 2016
PRO Number
Pro00057002
Researcher
Scott Sullivan

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Keywords
Obstetrics and Gynecology
Summary

The purpose of this study is to validate a test developed to determine preterm labor, to determine the optimal time to preform the test, and to discover biomarkers that will date a pregnancy and predict the time to birth.

Institution
MUSC
Recruitment Contact
Alison Line
843-792-3330
line@musc.edu

Hormone Replacement after Hysterectomy for Endometriosis: An Open Label Randomized Comparison of Conjugated Equine Estrogen (CEE) with CEE plus Bazodoxiphene (Duavee) Save

Date Added
June 9th, 2016
PRO Number
Pro00048347
Researcher
Bruce Lessey
Keywords
Obstetrics and Gynecology
Summary

The purpose of this study is to study an alternative to unopposed estrogen in premenopausal women that have endometriosis-related pain at the time of hysterectomy (removal of the womb). We will compare a type of estrogen alone with another combination medication that has the same type of estrgrogen plus another medication called bazodoxiphene (Duavee). We will compare the effect of Duavee with estrogen alone on endometriosis-associated pain scores after 6 months of therapy.

Institution
Greenville
Recruitment Contact
Cheryl Myers
864-455-5951
cmyers@ghs.org

Providing Long-Acting Reversible Contraceptives (LARCs) to New Mothers: the PLAN Study Save

Date Added
May 25th, 2016
PRO Number
Pro00053154
Researcher
Adam Tyson
Keywords
Obstetrics and Gynecology
Summary

Long-acting reversible contraceptive (LARC) services (including the contraceptive implant and intrauterine devices, or IUDs) are the most effective forms of reversible contraception. The immediate postpartum period (inpatient), prior to discharge from the hospital, can be a particularly favorable period to initiate a contraceptive method, reducing the risk of unintended pregnancy as many women resume sexual activity before their postpartum check-up or do not attend this checkup. Women who are pregnant and ineligible for Medicaid and without access to other forms of insurance are eligible to apply for Emergency Medicaid to cover the cost of hospital-based labor and delivery. Currently, Emergency Medicaid does not cover the costs of inpatient postpartum LARCs (or any other form of contraception). South Carolina Medicaid does cover these services, and the three hospitals participating in this study (Greenville Health System, Palmetto Health Richland, and the Medical University of South Carolina) currently provide inpatient LARC services. We propose to offer women delivering at these three hospitals with Emergency Medicaid coverage no-cost postpartum inpatient LARCs. Before they are discharged from the hospital, we will conduct brief surveys with women to assess their contraceptive choices and reasons; we will also review medical charts to describe prenatal care utilization and receipt of contraceptive counseling. The results of this study will inform discussions with South Carolina's Department of Health and Environmental Control (DHEC) on expanding the scope of Title X Family Planning contracts with hospitals to include inpatient postpartum LARCs so that this population of women has greater access to highly effective contraceptive services and is better able to prevent unintended pregnancies.

Institution
Greenville
Recruitment Contact
Patti Parker
864-455-1510
pparker2@ghs.org

A Phase 3 Study to Evaluate the Efficacy and Safety of Elagolix in Combination with Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated with Uterine Fibroids in Premenopausal Women Save

Date Added
May 24th, 2016
PRO Number
Pro00055245
Researcher
David Soper

Silhouette
Keywords
Drug Studies, Obstetrics and Gynecology
Summary

The purpose of this study is to test how well patients with heavy menstrual bleeding associated with uterine fibroids respond to a medication called Elagolix. It aims to possibly find out how heavy menstrual bleeding associated with uterine fibroids and related conditions develop and progress and how they can be diagnosed, monitored, or treated, possibly develop tests to identify which patients are likely to have different diseases, respond to the study drug or drugs of the same or similar class, or to predict the progression of the heavy menstrual bleeding associated with uterine fibroids, and to possibly develop new therapies, research methods, or technologies. Participation in the study will last approximately 20 months.

Institution
MUSC
Recruitment Contact
Tamara Pfeffer
843-792-6323
paynej@musc.edu

A Phase 3 Placebo-Controlled Study of Carboplatin/Paclitaxel With or Without Concurrent and Continuation Maintenance Veliparib (PARP Inhibitor) in Subjects With Previously Untreated Stages III or IV High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Save

Date Added
February 9th, 2016
PRO Number
Pro00050262
Researcher
Whitney Graybill

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Keywords
Cancer, Cancer/Gynecological, Drug Studies, Obstetrics and Gynecology, Women's Health
Summary

This study is for female subjects with previously untreated Stage III or IV high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. The investigational drug in this study is Veliparib (ABT-888). The purpose of this study is to compare the combination of carboplatin, paclitaxel and veliparib to carboplatin, paclitaxel, and placebo followed by continued therapy with either veliparib or placebo to determine if it slows the progression of your cancer.

Institution
MUSC
Recruitment Contact
HCC Clincial Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A comparison of remote prenatal care versus routine in-office visits for low-risk obstetric patients Save

Date Added
November 19th, 2015
PRO Number
Pro00047817
Researcher
Donna Johnson

Silhouette
Keywords
Obstetrics and Gynecology, Pregnancy
Summary

This study will evaluate a remote patient monitoring solution for low-risk pregnancies to assess whether or not it produces equivalent care with regards to clinical outcomes and patient satisfaction at a lower cost to the healthcare system and its participants. Furthermore, we will measure the ability of participants to collect and record the necessary data.

Institution
MUSC
Recruitment Contact
Shelby Neal
843-792-4500
nealsa@musc.edu

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