Recruiting

Commonly Used Drugs

Sponsor:

Duke University

Code:

NCT03511118

Conditions

Lactating Women on Select DOI

Breastfed Infants of Mothers on Select DOI

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Tranexamic acid (TXA)

labetalol

metformin

nifedipine

clindamycin

Study Details

Brief summary:

Over half of women in the US who are breastfeeding their infants take prescription drugs. You are being asked to participate in this study because you are breastfeeding your infant and are currently taking, as part of your medical care, at least one of the drugs we are studying. We are interested in studying drugs commonly prescribed to women who are breastfeeding so we can learn more about the amount of drug that is transferred to breastmilk and estimate how much of drug that is consumed by breastfed infants.

Conditions

Lactating Women on Select DOI

Breastfed Infants of Mothers on Select DOI

Study ID

NCT03511118

Start date

Oct 4, 2018

Status verified date

Apr, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 23, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1600 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Interventions

Tranexamic acid (TXA)

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

labetalol

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

metformin

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

nifedipine

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

clindamycin

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

oxycodone

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

azithromycin

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

escitalopram

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

sertraline

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

ondansetron

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Ciprofloxacin

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Doxycycline

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Levofloxacin

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Methylphenidate

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Sumatriptan

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Citalopram

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Cyclobenzaprine

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Furosemide

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Gabapentin

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Hydrochlorothiazide

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Hydroxyurea

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Rosuvastatin

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Topiramate

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Trazodone

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Valganciclovir

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Venlafaxine

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Verapamil

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Remdesivir

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Anakinra

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Tocilizumab

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Fluvoxamine

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Amoxicillin

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Bupropion

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Duloxetine

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Hydrocodone

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Levetiracetam

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Paroxetine

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Buprenorphine

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Primary outcome measure

  • M/P ratio [ Time Frame: Until the infant becomes 180 days of age ]
  • DID [ Time Frame: Until the infant becomes 180 days of age ]
  • RID [ Time Frame: Until the infant becomes 180 days of age ]
  • I/M ratio [ Time Frame: Until the infant becomes 180 days of age ]

Central Contacts and Locations

Locations

University of California-San Diego Medical Center

Recruiting

La Jolla, California, United States, 92093

Contacts

Principal Investigator:

Christina Chambers, PhD

Loma Linda University Health

Recruiting

Loma Linda, California, United States, 92354

Contacts

Principal Investigator:

Larry Ngo

Ann and Robert H. Lurie Childrens Hospital of Chicago

Recruiting

Chicago, Illinois, United States, 60614

Contacts

Principal Investigator:

William Muller, MD

Children's Hospital and Clinics - Minneapolis

Recruiting

Minneapolis, Minnesota, United States, 55404

Contacts

Principal Investigator:

Andrea Lampland, MD

Duke University Maternal and Fetal Medicine

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Principal Investigator:

Brenna Hughes, MD

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Principal Investigator:

Nicole Marshall

University of Pittsburgh School of Medicine

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Leigh Ann Shaver

shaverla2@upmc.edu

Principal Investigator:

Anne-Marie Rick, MD

Texas Tech University Health Sciences Center School of Medicine.

Recruiting

Amarillo, Texas, United States, 79106

Contacts

Principal Investigator:

Kaytlin Krutsch, PharnD

University of Texas Medical Branch - Galveston

Recruiting

Galveston, Texas, United States, 77555

Contacts

Sashank Komanduri

sakomand@utmb.edu

Principal Investigator:

Gayle Olson, MD

University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Pamela Berens, MD

The Women's Hospital of Texas

Recruiting

Houston, Texas, United States, 77054

Contacts

Principal Investigator:

Olaide Balogun, MD

University of Texas Health Science Center

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Principal Investigator:

Olaide Balogun, MD

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Principal Investigator:

Kathleen Job

More Information

Sponsor

Duke University

Last update posted

Jul 29, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Duke University on 2026-07-29.