Research - Current Clinical Studies

Division of Reproductive Endocrinology & Infertility

Uterine Fibroid Study
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

National Institutes of Health (NIH) CCN012A Study
A dose-finding study to evaluate serum estradiol levels with use of contraceptive vaginal rings releasing Nestorone® and escalating doses of estradiol in normal cycling women

Anterior/Apical Pelvic Organ Prolapse Study
A Prospective, Non-Randomized, Parallel Cohort, Multi-center Study of Uphold LITE vs. Native Tissue for the Treatment of Women with Anterior/Apical Pelvic Organ Prolapse

Primary Amenorrhea with Hypogonadotropic Hypogonadism Study
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating Three Doses of Subcutaneous Pulsatile GnRH Administered via OmniPod Pump for Ovulation Induction in Female Subjects with Primary Amenorrhea with Hypogonadotropic Hypogonadism

Division of Maternal Fetal Medicine

Preterm Birth Prevention
Assessment of DHA On Reducing Early preterm birth (ADORE)

Influenza
Defining the Impact of Initial Influenza Exposure on Immunity in Infants (IMPRINT)

Vaccines
A Prospective, Randomized, Clinical Trial to Compare Adverse Birth Outcomes in Pregnant Women Receiving Quadrivalent Recombinant Influenza Vaccine (RIV4) versus Quadrivalent Inactivated Influenza Vaccine (IIV4) (Flublok)

Preeclampsia
A Phase 2b/3a, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of AMAG-423, a Digoxin Immune Fab, in Antepartum Subjects with Severe Preeclampsia (DigiFab)

Alloimmunization
A Multicenter, Open-Label Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of M281 Administered to Pregnant Women at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN) (Unity/Momenta)

A Multicenter, Prospective Observational Study to Characterize the Clinical Course of Pregnant Women and Children at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (Unity/ Momenta Observational)

Prenatal Genetics
Collection of Whole Blood Specimens from Pregnant Women at Increased Risk for Fetal Chromosomal Abnormality for use In Development of a Noninvasive Prenatal Test in the Detection of the Relative Quantity of Chromosomal Material in Circulating Cell-Free DNA Extracted from Maternal Plasma (Sequenom)

Amniotic Fluid
Novel Biomarkers in Amniotic Fluid to Predict Fetal Lung Maturity and Clinical Respiratory Outcomes (Amnio)

Intraamniotic Infection
Maternal and Fetal Immune Modulation Induced by Chorioamnionitis (Chorio)

Division of Gynecology Oncology

CR845-CLIN3001: Abdominal Surgery Study
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Adaptive Design Study Evaluating the Analgesic Efficacy and Safety of Intravenous CR845 in Patients Undergoing Abdominal Surgery

Ariel2: Ovarian Cancer Study
A Phase 2, Open-Label Study of Rucaparib in Patients with Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

ET743-OVC-3006: Ovarian Cancer Study
A Randomized, Open-Label Study Comparing the Combination of YONDELIS® and DOXIL®/CAELYX® With DOXIL®/CAELYX® Monotherapy for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer.

GOG 3005
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

GOG 0277
A Phase III Randomized Trial of Gemcitabine (NSC# 613327) Plus Docetaxel (NSC# 628503) Followed by Doxorubicin (NSC# 123127) Versus Observation for Uterus-Limited, High-Grade Uterine Leiomyosarcoma

GOG 0238
A Randomized Trial of Pelvic Irradiation With or Without Concurrent Weekly Cisplatin in Patients with Pelvic-Only Recurrence of Carcinoma of the Uterine Corpus

GOG 0213
A Phase III Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel Alone or in Combination with Bevacizumab (NSC #704865, IND #7921) Followed by Bevacizumab and Secondary Cytoreductive Surgery in Platinum-Sensitive, Recurrent Ovarian, Peritoneal Primary and Fallopian Tube Cancer

GOG 0281
A Randomized Phase II/III Study to Assess the Efficacy of Trametinib (GSK 1120212) with Recurrent or Progressive Low-Grade Serous Ovarian Cancer or Peritoneal Cancer

GOG 0263
Randomized Phase III Clinical Trial of Adjuvant Radiation versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated with Initial Radical Hysterectomy and Pelvic Lymphadenectomy.

GOG 0724
Phase III Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy with or without Adjuvant Chemotherapy in High-Risk Patients with Early-Stage Cervical Carcinoma Following Radical Hysterectomy

GOG 0278
Evaluation of Physical Function and Quality of Life (QOL) Before and After Non-Radical Surgical Therapy (Extra Fascial Hysterectomy or Cone Biopsy with Pelvic Lymphadenectomy) for Stage IA1 (LVSI+) and IA2-IB1 (≤ 2CM) Cervical Cancer

GOG 0274: The Outback Trial
A Phase III Trial of Adjuvant Chemotherapy Following Chemoradiation as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: THE OUTBACK TRIAL

GOG 0279
A Phase II Trial Evaluating Cisplatin (NSC #119875) and Gemcitabine (NSC # 613327) Concurrent with Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Locally Advanced Squamous Cell Carcinoma of the Vulva

GOG 0286-B
Randomized Phase II/III Study of Paclitazel/Carboplatin/Metformin (NSC#91485) versus Paclitaxel/Carboplatin/Placebo as Initial Therapy for Measurable Stage III or IVA, Stage IVB, or Recurrent Endometrial Cancer