- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03511118
Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
Study Overview
Status
Intervention / Treatment
- Drug: Tranexamic acid (TXA)
- Drug: labetalol
- Drug: metformin
- Drug: nifedipine
- Drug: clindamycin
- Drug: oxycodone
- Drug: azithromycin
- Drug: escitalopram
- Drug: sertraline
- Drug: ondansetron
- Drug: Ciprofloxacin
- Drug: Doxycycline
- Drug: Levofloxacin
- Drug: Methylphenidate
- Drug: Sumatriptan
- Drug: Citalopram
- Drug: Cyclobenzaprine
- Drug: Furosemide
- Drug: Gabapentin
- Drug: Hydrochlorothiazide
- Drug: Hydroxyurea
- Drug: Rosuvastatin
- Drug: Topiramate
- Drug: Trazodone
- Drug: Valganciclovir
- Drug: Venlafaxine
- Drug: Verapamil
- Drug: Remdesivir
- Drug: Anakinra
- Drug: Tocilizumab
- Drug: Fluvoxamine
- Drug: Amoxicillin
- Drug: Bupropion
- Drug: Buprenorphine
- Drug: Hydrocodone
- Drug: Levetiracetam
- Drug: Paroxetine
- Drug: Duloxetine
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Emily Forgey
- Phone Number: 919-660-8720
- Email: emily.forgey@duke.edu
Study Contact Backup
- Name: Cheryl Alderman
- Phone Number: 919-966-8349
- Email: cheryl.alderman@duke.edu
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A 5W9
- Completed
- Lawson Health Research Institute
-
-
Quebec
-
Montréal, Quebec, Canada, H3T IC5
- Completed
- Centre Hospitalier Universitaire Sainte-Justine
-
-
-
-
California
-
La Jolla, California, United States, 92093
- Recruiting
- University of California-San Diego Medical Center
-
Contact:
- Kerri Bertrand
- Phone Number: 858-246-1713
- Email: kdutcher@ucsd.edu
-
Contact:
- Gretchen Bandoli
- Phone Number: 858-246-1733
- Email: gbandoli@ucsd.edu
-
Principal Investigator:
- Christina Chambers, PhD
-
Sub-Investigator:
- Michelle Leff
-
Loma Linda, California, United States, 92354
- Recruiting
- Loma Linda University Health
-
Contact:
- Jose Navarro
- Phone Number: 909-558-5830
- Email: jdnavarro@llu.edu
-
Contact:
- Stephanie Wells
- Phone Number: 909-558-5830
- Email: scwells@llu.edu
-
Sub-Investigator:
- Adrian Lavery
-
Principal Investigator:
- Larry Ngo
-
-
Illinois
-
Chicago, Illinois, United States, 60614
- Recruiting
- Ann and Robert H. Lurie Childrens Hospital of Chicago
-
Contact:
- Laura Fearn
- Phone Number: 312-227-6280
- Email: lfearn@luriechildrens.org
-
Contact:
- Mayra Gomez
- Phone Number: 312-227-8274
- Email: mmgomez@luriechildrens.org
-
Principal Investigator:
- William Muller, MD
-
Chicago, Illinois, United States, 60611
- Completed
- Northwestern University
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Completed
- Indiana University Health
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- Recruiting
- University of Iowa Hospitals and Clinics
-
Contact:
- Beverly Vermace
- Phone Number: 319-356-4587
- Email: beverly-vermace@uiowa.edu
-
Contact:
- Maureen Austin
- Phone Number: 319-356-7025
- Email: maureen-austin@uiowa.edu
-
Principal Investigator:
- Temitope Awelewa, MD
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55404
- Recruiting
- Children's Hospital and Clinics - Minneapolis
-
Principal Investigator:
- Andrea Lampland, MD
-
Contact:
- Quast Emily
- Phone Number: 612-813-6864
- Email: emily.quast@childrensmn.org
-
Contact:
- Molly fisher
- Phone Number: 612-813-6864
- Email: molly.fisher@childrensmn.org
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87131
- Completed
- University of New Mexico, Health Sciences Center
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- Completed
- University of North Carolina Hospital
-
Durham, North Carolina, United States, 27705
- Recruiting
- Duke University Maternal and Fetal Medicine
-
Contact:
- Thelma Fitzgerald
- Phone Number: 919-684-1224
- Email: thelma.fitzgerald@duke.edu
-
Principal Investigator:
- Brenna Hughes, MD
-
Contact:
- Jordynn Akins
- Phone Number: 919-681-0013
- Email: jordynn.akins@duke.edu
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Recruiting
- Oregon Health & Science University
-
Contact:
- Monica Rincon
- Phone Number: 503-494-8748
- Email: rincon@ohsu.edu
-
Principal Investigator:
- Nicole Marshall
-
Contact:
- Daniela Cramer
- Phone Number: 503-494-8742
- Email: cramerda@ohsu.edu
-
Sub-Investigator:
- Karen Gibbins
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Completed
- Hospital of the University of Pennsylvania Department of Maternal Fetal Medicine
-
Pittsburgh, Pennsylvania, United States, 15213
- Recruiting
- University of Pittsburgh School of Medicine
-
Contact:
- Matthew Butoryak
- Phone Number: 412-692-8181
- Email: butoryakm@upmc.edu
-
Principal Investigator:
- Anne-Marie Rick, MD
-
-
Texas
-
Amarillo, Texas, United States, 79106
- Not yet recruiting
- Texas Tech University Health Sciences Center School of Medicine.
-
Contact:
- Elizabeth Tilley, PhD
- Phone Number: 806-414-9872
- Email: Elizabeth.tilley@ttuhsc.edu
-
Principal Investigator:
- Kaytlin Krutsch, PharnD
-
Sub-Investigator:
- Teresa Baker, MD
-
Galveston, Texas, United States, 77555
- Recruiting
- University of Texas Medical Branch - Galveston
-
Contact:
- Leah McCoy
- Phone Number: 409-747-1761
- Email: lemccoy@utmb.edu
-
Contact:
- Lizzet Aguillon
- Phone Number: 409-772-0305
- Email: liaguill@utmb.edu
-
Principal Investigator:
- Gayle Olson, MD
-
Houston, Texas, United States, 77030
- Recruiting
- University of Texas Health Science Center at Houston
-
Principal Investigator:
- Pamela Berens, MD
-
Contact:
- Josephine Turner
- Phone Number: 713-513-6419
- Email: josephine.turner@uth.tmc.edu
-
San Antonio, Texas, United States, 78229
- Not yet recruiting
- University of Texas Health Science Center
-
Contact:
- Janette Rodela, RN
- Phone Number: 615-344-9551
- Email: Janette.Rodela@HCAhealthcare.com
-
Principal Investigator:
- Olaide Balogun, MD
-
Sub-Investigator:
- Kaashif Ahmad, MD
-
-
Utah
-
Salt Lake City, Utah, United States, 84132
- Recruiting
- University of Utah
-
Principal Investigator:
- Kathleen Job
-
Sub-Investigator:
- Lauren Theilen
-
Contact:
- Kelly Christensen
- Phone Number: 801-674-7234
- Email: kelly.vorwaller@hsc.utah.edu
-
-
Washington
-
Seattle, Washington, United States, 98195-7630
- Completed
- University of Washington
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Lactating women who are receiving at least one DOI per SOC who are ≤180 days postpartum, and their infants (≤180 days of age) who receive maternal breastmilk.
- Informed consent/HIPAA obtained, according to local IRB/REB/IEC guidelines, prior to any study-related procedures. Lactating women who are not legal adults and their breastfed infants may be enrolled if they assent to participate in the study and consent is obtained from their legal guardian according to local IRB/REB/IEC guidelines.
Exclusion Criteria:
- Any concomitant condition which, in the opinion of the physicians providing patient care or the principal investigator conducting the study, would preclude a subject's participation in the study.
- Known pregnancy during PK sampling.
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Tranexamic acid (TXA)
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. |
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
|
labetalol
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. |
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
|
metformin
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. |
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
|
nifedipine
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. |
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
|
clindamycin
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. |
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
|
oxycodone
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. |
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
|
azithromycin
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. |
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
|
escitalopram
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. |
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
|
sertraline
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. |
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
|
ondansetron
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. |
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
|
Ciprofloxacin
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. |
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
|
Doxycycline
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. |
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
|
Levofloxacin
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. |
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
|
Methylphenidate
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. |
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
|
Sumatriptan
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. |
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
|
Citalopram
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. |
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
|
Cyclobenzaprine
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. |
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
|
Furosemide
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. |
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
|
Gabapentin
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. |
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
|
Hydrochlorothiazide
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. |
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
|
Hydroxyurea
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. |
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
|
Rosuvastatin
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. |
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
|
Topiramate
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. |
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
|
Trazodone
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. |
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
|
Valganciclovir
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. |
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
|
Venlafaxine
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. |
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
|
Verapamil
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. |
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
|
Remdesivir
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. |
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
|
Anakinra
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. |
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
|
Tocilizumab
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. |
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
|
Fluvoxamine
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. |
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
|
Amoxicillin
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. |
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
|
Bupropion
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. |
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
|
Buprenorphine
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. |
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
|
Hydrocodone
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. |
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
|
Levetiracetam
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. |
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
|
Paroxetine
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. |
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
|
Duloxetine
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. |
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
M/P ratio
Time Frame: Until the infant becomes 180 days of age
|
Characterize the pharmacokinetics using maternal milk/plasma exposure ratio is calculated by dividing the BMS01 drug of interest breastmilk concentration by the BMS01 drug of interest in maternal plasma concentration.
|
Until the infant becomes 180 days of age
|
DID
Time Frame: Until the infant becomes 180 days of age
|
Pharmacokinetics is characterized by estimated daily infant dose-daily infant dose which estimates the quantity of drug delivered to an infant via breastmilk in a given day.
|
Until the infant becomes 180 days of age
|
RID
Time Frame: Until the infant becomes 180 days of age
|
Pharmacokinetics is characterized by relative infant dose is a method of relating the potential dose of the drug delivered to the infant to the typical therapeutic dose given to the mother.
|
Until the infant becomes 180 days of age
|
I/M ratio
Time Frame: Until the infant becomes 180 days of age
|
Pharmacokinetics is characterized using infant maternal/exposure ratio.
IM ratio is calculated using the average infant plasma concentration of the BMS01 drug of interest and historical value of clearance in infants.
|
Until the infant becomes 180 days of age
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety profile of commonly used drugs in infants exposed to drugs in breastmilk
Time Frame: Until the infant becomes 180 days of age
|
see Cohort 1-31 for listing of drugs
|
Until the infant becomes 180 days of age
|
AE
Time Frame: Up until 180 days of age
|
Safety profile of commonly used drugs in infants exposed to drugs in breastmilk is characterized by Adverse Events(AE) which are collected at each time point when the study-specific procedure occurred and up until 1 hour after.
|
Up until 180 days of age
|
SAE
Time Frame: Up until 180 days of age
|
Safety profile of commonly used drugs in infants exposed to drugs in breastmilk is characterized by Serious Adverse Events which are directly related to study procedures and were recorded from participants (infant or mother) at each time point when the study-specific procedure occurred and up until 1 hour after.
|
Up until 180 days of age
|
ESI
Time Frame: Until the infant becomes 180 days of age
|
Safety profile of commonly used drugs in infants exposed to drugs in breastmilk is characterized by Events of Special Interest(ESI) which include any pre-specified safety event that could be related to BMS01 drug of interest exposure.
ESI's are only assessed for infants and only at study visits from the time the BMS01 DOI was initiated in mother and infant began breast milk feeding through the end of the study / infant age ≤ 180 days
|
Until the infant becomes 180 days of age
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kanecia Zimmerman, MD, Duke University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Vasodilator Agents
- Anti-Infective Agents
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiviral Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Antirheumatic Agents
- Fibrin Modulating Agents
- Antimetabolites
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Natriuretic Agents
- Dermatologic Agents
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Anti-Bacterial Agents
- Analgesics, Opioid
- Narcotics
- Tranquilizing Agents
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Dopamine Agents
- Serotonin 5-HT1 Receptor Agonists
- Serotonin Receptor Agonists
- Serotonin Antagonists
- Anti-Anxiety Agents
- Narcotic Antagonists
- Diuretics
- Cytochrome P-450 Enzyme Inhibitors
- Anticonvulsants
- Antidepressive Agents, Second-Generation
- Serotonin and Noradrenaline Reuptake Inhibitors
- Antidepressive Agents, Tricyclic
- Antimanic Agents
- Protein Synthesis Inhibitors
- Cytochrome P-450 CYP2D6 Inhibitors
- Respiratory System Agents
- Serotonin 5-HT3 Receptor Antagonists
- Calcium-Regulating Hormones and Agents
- Antifibrinolytic Agents
- Hemostatics
- Coagulants
- Reproductive Control Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Calcium Channel Blockers
- Dopamine Uptake Inhibitors
- Neuromuscular Agents
- Antipruritics
- Central Nervous System Stimulants
- Nootropic Agents
- Antimalarials
- Antitussive Agents
- Tocolytic Agents
- Sympathomimetics
- Antisickling Agents
- Cytochrome P-450 CYP1A2 Inhibitors
- Sodium Chloride Symporter Inhibitors
- Adrenergic alpha-1 Receptor Antagonists
- Adrenergic alpha-Antagonists
- Vasoconstrictor Agents
- Muscle Relaxants, Central
- Sodium Potassium Chloride Symporter Inhibitors
- Anti-Infective Agents, Urinary
- Cytochrome P-450 CYP2C19 Inhibitors
- Selective Serotonin Reuptake Inhibitors
- Buprenorphine
- Sertraline
- Duloxetine Hydrochloride
- Citalopram
- Gabapentin
- Paroxetine
- Bupropion
- Rosuvastatin Calcium
- Metformin
- Methylphenidate
- Doxycycline
- Tranexamic Acid
- Clindamycin
- Hydroxyurea
- Ciprofloxacin
- Interleukin 1 Receptor Antagonist Protein
- Amoxicillin
- Hydrochlorothiazide
- Valganciclovir
- Furosemide
- Azithromycin
- Venlafaxine Hydrochloride
- Nifedipine
- Oxycodone
- Levofloxacin
- Ondansetron
- Levetiracetam
- Labetalol
- Verapamil
- Fluvoxamine
- Topiramate
- Remdesivir
- Hydrocodone
- Trazodone
- Cyclobenzaprine
- Sumatriptan
- Escitalopram
Other Study ID Numbers
- Pro00088919
- HHSN275201000003I/27500051 (Other Grant/Funding Number: NICHD)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lactating Women on Select DOI
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Duke UniversityThe Emmes Company, LLCRecruitingHIV Infections | Lactating Women on Select DOI | Breastmilk Fed Infants of Mothers on Select DOISouth Africa
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Alkermes, Inc.CompletedFocus of Study is on Healthy Lactating WomenUnited States
-
Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedHealthy Lactating WomenBelgium
-
Eisai Inc.Completed
-
Esperion Therapeutics, Inc.Recruiting
-
Supernus Pharmaceuticals, Inc.CompletedHealthy Lactating WomenUnited States
-
Bristol-Myers SquibbNot yet recruitingLactating Women | Breastfed Infants
-
University of OxfordMahidol Oxford Tropical Medicine Research UnitWithdrawn
-
Assistance Publique - Hôpitaux de ParisCompletedLactating Women Who Give Their Milk to One of the 6 Milk Banks Participating in the StudyFrance
-
International Centre for Diarrhoeal Disease Research...University of SydneyCompletedPregnant Women | Stunting | Breastfeeding | Infant Nutrition | Infant Malnutrition | Lactating MotherBangladesh
Clinical Trials on Tranexamic acid (TXA)
-
HaEmek Medical Center, IsraelWithdrawn
-
Rush University Medical CenterWithdrawnArthritis | Anemia | Total Knee Arthroplasty | Total Hip ArthroplastyUnited States
-
Boston Children's HospitalCompletedCraniosynostosisUnited States
-
NYU Langone HealthTerminated
-
Mansoura UniversityNot yet recruiting
-
Samsung Medical CenterUnknownBleeding | Transfusion Related ComplicationKorea, Republic of
-
Cristina MartinezCompleted
-
Rush University Medical CenterCompletedBlood Loss After Primary Total Joint Arthroplasty | Need for Blood Transfusion After Total Joint ArthroplastyUnited States
-
University of Kansas Medical CenterCompletedSarcoma,Soft Tissue | Musculoskeletal CancerUnited States
-
NYU Langone HealthCompletedTibial Tubercle OsteotomyUnited States