|
Validation of 24-hour trough concentration as a surrogate for intensive pharmacokinetic measurements for a combined oral contraceptive pill containing desogestrel
This study aims to validate prior pharmacokinetic research with combined oral contraceptive pill (COCP) users that supports utilizing a 24-hour trough concentration as an accurate proxy for the intensive pharmacokinetic parameter of area under the curve (gold standard pharmacokinetics). CO...more > Protocol #: 21-3936 Location: Comprehensive Women's Health Center |
|
Harnessing Cells from Human Milk; Linking Lactation to Metabolism
If you join the study, you will be part of the study for up to a month and a half, lasting until 2 weeks after you deliver your baby. If you decide to take part in the study, the normal care that you receive during and after pregnancy would not change. You would be asked to provide breastm...more > Protocol #: 21-2835 Location: University of Colorado Hospital |
|
Contraceptive Hormone and Reward Measurement (CHARM Study)
The study is examining the effects of hormonal oral contraceptives (OCPs) on brain processes and emotional wellbeing. Study participants will: Participate in 3 study sessions, one online and two in-person, over the course of 2 months. Complete interviews and questionnaires Taking a...more > Protocol #: 21-3530 Locations: Brain Imaging Center (BIC); Outpatient CTRC |
|
Premature Vascular Aging in Women following an In Vitro Fertilization Pregnancy
Main Procedures Involved: Ultrasound of blood vessels, blood draws, 24-hour blood pressure monitoring, sleep monitoring, body composition testing...more > Protocol #: 21-2903 Locations: Outpatient CTRC; University of Colorado Hospital |
|
A011801 - The CompassHER2 Trials (Comprehensive Use of Pathologic Response Assessment to Optimize Therapy in HER2-Positive Breast Cancer) CompassHER2 Residual Disease (RD), a Double-Blinded, Phase III Randomized Trial of T-DM1 Compared With T-DM1 and Tucatinib
Protocol #: 21-2558 Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
|
Nexplanon Extension Trial Study
-11 visits over 27 months -Physical exam, pelvic exam, Pap smear (if needed), STI screening -Blood draws -Daily e-diary completion ...more > Protocol #: 20-2734 Location: Comprehensive Women's Health Center |
|
NRG-CC008: A Non-Randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-oophorectomy to Reduce the Risk of Ovarian Cancer Among BRCA1 Carriers [SOROC]
Protocol #: 20-2079 Locations: Highlands Ranch Hospital; Memorial Hospital Central; Memorial Hospital North; University of Colorado Hospital |
|
A Phase I Dose Escalation and Dose Expansion and Phase II Monotherapy Open-label, First-in-Human, Multicenter Study of OP-1250 in Adult Subjects with Advanced and/or Metastatic Hormone Receptor (HR)-positive, HER2-negative Breast Cancer
Protocol #: 20-2279 Locations: Lone Tree Medical Center; University of Colorado Hospital |
|
A randomized, multicenter, double-blind Phase 3 study of amcenestrant (SAR439859) plus palbociclib versus letrozole plus palbociclib for the treatment of patients with ER (+), HER2 (-) breast cancer who have not received prior systemic anti-cancer treatment for advanced disease
Protocol #: 20-2060 Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
|
Effect Of Neonatal BCG Administration On Innate And Adaptive Immune Responses To Infection With Rotavirus Live Attenuated Vaccine Strain In HIV-Exposed And Unexposed Infants
Women in this study will consent in the third trimester and have cord blood collected at the time of delivery. The infant will have four visits at Children's Hospital Colorado....more > Protocol #: 20-0593 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
|
A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) Versus Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive Breast Cancer Patients whose Disease has Progressed on Endocrine Therapy in the Metastatic Setting (DESTINY-Breast06)
Protocol #: 20-2167 Location: University of Colorado Hospital |
|
A Phase 3, Double-Blind, Placebo-Controlled, Multicenter Clinical Study comparing Chemo-Immunotherapy (Paclitaxel-Carboplatin-Oregovomab) versus Chemotherapy (Paclitaxel-Carboplatin-Placebo) in Patients with Advanced Epithelial Ovarian, Fallopian Tube or Peritoneal Carcinoma (FLORA-5)
Protocol #: 20-1026 Location: University of Colorado Hospital |
|
Evaluation of Compensatory Reserve in Obstetrical Patients
A pulse oximeter will be applied to your finger to collect data regarding your compensatory reserve volume....more > Protocol #: 14-1996 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
|
Disordered Eating, Energy Availability, and Quality of Life in Adolescent Athletes
Participants will receive a DEXA scan and will wear a FitBit for a week to track HR, sleep, and exercise. The participant will also log their food intake for the week. Compensation included. ...more > Protocol #: 20-1681 Locations: Childrens Hospital Colorado; Outpatient CTRC; University of Colorado Hospital |
|
Nexplanon Use in Women Primarily Choosing a Combined Oral Contraceptive: a Multicenter Trial
1. Women who desire a COC for contraception will be willing to initiate and continue an ENG implant as a continuous back-up method. 2. Women using a COC concomitantly with ENG implant will have low rates (<5%) of ENG discontinuation for bleeding complaints. 3. A high percentage of wome...more > Protocol #: 20-1945 Location: Comprehensive Women's Health Center |
|
Influenza-Specific Immunity and Responses to Inactivated Influenza Vaccine in Infants: Effect of Maternal Vaccination During Pregnancy
This study aims to learn more about how babies' immune systems react to the influenza vaccine and if there is any difference between babies whose mothers receive the influenza vaccine, or not, before the baby is born. Study visits will take place during prenatal care and delivery as well a...more > Protocol #: 20-1074 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
|
In-Utero Vascular Accidents in Neonates from COVID-19 Infected Mothers
This study plans to learn more about how COVID-19 infection during pregnancy may have direct effects on the developing baby 30 days after birth. ...more > Protocol #: 20-1399 Locations: Childrens Hospital Colorado; Outpatient CTRC; University of Colorado Hospital |
|
A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF GDC-9545 COMBINED WITH PALBOCICLIB COMPARED WITH LETROZOLE COMBINED WITH PALBOCICLIB IN PATIENTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER
Protocol #: 20-0884 Locations: Highlands Ranch Hospital; Lone Tree Medical Center; University of Colorado Hospital |
|
A Phase 2A, Double-blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Saroglitazar Magnesium 4 mg Tablets for Treating Nonalcoholic Fatty Liver Disease (NAFLD) in Women With Polycystic Ovary Syndrome (PCOS)
Protocol #: 20-0589 Locations: Outpatient CTRC; University of Colorado Hospital |
|
Healthy Behaviors Study
How do childhood experiences shape health behaviors in adulthood? ...more > Protocol #: 20-0578 Location: Sheridan Health Services |
|
Birth Control Hormonal Pill Study
-9 visits over 13.5 months -Physical exam, pelvic exam -Trans-vaginal ultrasound, blood draws -Daily e-diary completion...more > Protocol #: 19-2895 Location: Comprehensive Women's Health Center |
|
Birth Control Hormonal Injection/Shot Study
-36 visits over 9 months -Physical Exam, Pelvic Exam-On screening Visit and Exit visit only -Trans-Vaginal Ultrasound, Blood draws-On every visit -Bleeding Diaries-will be filled collected weekly after Visit 3...more > Protocol #: 19-2820 Location: Comprehensive Women's Health Center |
|
Pharmacology of Marijuana During Pregnancy
This study will enroll pregnant women who use marijuana during their pregnancy and ask them to provide urine and blood samples at two prenatal visits. At delivery they will again be asked to provide blood and urine samples, the placenta, as well as blood from the baby's umbilical cord. Sur...more > Protocol #: 19-1757 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
|
A Phase 2, Multi-arm, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of IPI-549 Administered in Combination with Front-line Treatment Regimens in Patients with Locally Advanced and/or Metastatic Triple-Negative Breast Cancer or Renal Cell Carcinoma.
Protocol #: 19-1337 Locations: Lone Tree Medical Center; University of Colorado Hospital |
|
NRG-BR004: A Randomized, Double-Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer
Protocol #: 19-1152 Locations: Greeley Campus; Harmony Campus; Highlands Ranch Hospital; Lone Tree Medical Center; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
|
SGNTUC-016: Randomized, double-blind, phase 3 study of tucatinib or placebo in combination with ado-trastuzumab emtansine (T-DM1) for subjects with unresectable locally-advanced or metastatic Her2+ breast cancer
Protocol #: 19-6076 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital |
|
Treating PCOS with Semaglutide vs Active Lifestyle Intervention (TEAL Study)
The study consists of an initial study visit to determine eligibility, 2 inpatient visits (one prior to starting treatment and one at the end of the 4 month treatment intervention), and one short visit midway between the study....more > Protocol #: 19-0636 Locations: Childrens Hospital Colorado; Outpatient CTRC; University of Colorado Hospital |
|
A randomized phase II study of anti-PD-1 and limited metastatic site radiation therapy versus anti-PD-1 alone for patients with microsatellite instability-high (MSI-H) and mismatch repair deficient (dMMR) metastatic solid tumors
Protocol #: 19-0556 Locations: Lone Tree Medical Center; University of Colorado Hospital |
|
A Randomized, Double-Blind, Placebo-Controlled Phase 1b Study for Repeated Administration of Granulocyte Colony-Stimulating Factor (G-CSF; filgrastim) on Hot Flashes and Other Vasomotor Symptoms of Menopause in Postmenopausal Women
This study will look at the effect of Filgrastim on women who are menopausal and are experiencing hot flashes. We expect a reduction in the number of hot flashes the participants experience if they receive the study medication. ...more > Protocol #: 18-1254 Locations: Outpatient CTRC; University of Colorado Hospital |
|
A Phase II, randomized, double-blind, study of the use of Rucaparib vs. placebo maintenance therapy in metastatic and recurrent endometrial cancer
This is a phase II, randomized, double-blind, trial for the use of Rucaparib as maintenance therapy in metastatic and recurrent endometrial cancer. ...more > Protocol #: 18-0567 Locations: Fox Chase Cancer Center; University of Colorado Hospital; University of Pennsylvania; University of Pittsburgh Cancer Institute |
|
PLACENTAL PROTEINS AND PREMATURITY (P3 STUDY)
This study plans to learn more about why babies born prematurely sometimes can have problems with infections, breathing, feeding, vision, and brain function....more > Protocol #: 18-0637 Locations: Outpatient CTRC; University of Colorado Hospital |
|
EA1151: Tomosynthesis Mammographic Imaging Screening Trial (TMIST)
Participants in this trial will be randomized to receive either 2D or 3D mammograms for the first 5 years of the research study, either ever year or every other year depending on personal risk factors. Information will be collected on breast cancer status for 8 years in total. ...more > Protocol #: 18-0392 Locations: Highlands Ranch Hospital; Outpatient CTRC; University of Colorado Hospital |
|
Assessment of NAAT to Determine GBS Status After Initiation of Intrapartum Antibiotic Prophylaxis
This study plans to learn more about a new method of testing for GBS, to see if it can be reliably used after antibiotics have been started. ...more > Protocol #: 17-2177 Location: University of Colorado Hospital |
|
Effects of high altitude on AMPK activation
This study plans to learn more about differences in pregnancy between high and low altitudes in Colorado. Participants will be asked to complete ultrasounds and provide blood samples throughout pregnancy, and provide samples such as cord blood at the time of delivery....more > Protocol #: 14-2178 Locations: CTRC-perinatal; CU John C. Hobbins Perinatal Center; University of Colorado Hospital |
|
The pharmacogenomics of contraception: genetic determinants of etonogestrel pharmacokinetics
? 1 visit lasting 30 minutes ? Visit includes a questionnaire and a blood draw....more > Protocol #: 16-2462 Location: University of Colorado Hospital |