Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants



Status:Recruiting
Healthy:No
Age Range:Any
Updated:3/28/2019
Start Date:October 4, 2018
End Date:September 22, 2019
Contact:Leigh Gosnell
Email:leigh.gosnell@duke.edu
Phone:+1 919 668-1280

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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.

The purpose of this study is to understand if the study drugs of interest are found in
breastmilk and how much; to estimate the amount of drug that is consumed by breastfed infants
and what effect this may have on infants; and to share what we learn with other researchers.
The study drugs of interest have Food and Drug Administration (FDA) approval, but there is
little or no information about the amount of drug found in the breastmilk of mothers who take
them; the amount of drug that may be transferred to their infant's through breastmilk; or the
effects this transfer may have on their infants. During this study we will ask to collect
breastmilk and blood from mothers, and blood from infants, to measure the amount of study
drug of interest in these body fluids. Results from this study will help researchers better
understand how much of the study drug of interest is in your blood and breastmilk, and how
much of the study drug of interest may be in your infant's blood because of breastfeeding.

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.
We found this trial at
17
sites
303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Katherine Wisner, MD
Phone: 312-695-1923
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Chicago, IL
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Principal Investigator: Pamela Berens, MD
Phone: 713-500-6467
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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Houston, TX
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Nicole Marshall
Phone: 503-494-8748
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Mary Hébert, Pharm.D
Phone: 540-525-0121
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Seattle, WA
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Albuquerque, New Mexico 87131
Principal Investigator: Nicole Urrea
Phone: 505-272-9898
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Albuquerque, NM
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Chapel Hill, North Carolina 27599
Principal Investigator: Alison Stuebe, MD
Phone: 984-974-8942
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Chapel Hill, NC
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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Principal Investigator: William Muller, MD
Phone: 312-227-6280
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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Chicago, IL
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Durham, North Carolina 27705
Principal Investigator: Brenna Hughes, MD
Phone: 919-613-9630
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Durham, NC
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Galveston, Texas
Principal Investigator: George Saade, MD
Phone: 409-747-1761
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Galveston, TX
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Indianapolis, Indiana 46202
Principal Investigator: David Haas, MD
Phone: 317-948-2129
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Indianapolis, IN
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
Principal Investigator: Temitope Awelewa, MD
Phone: 319-356-2924
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Iowa City, IA
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La Jolla, California 92093
Principal Investigator: Christina Chambers, PhD
Phone: 858-246-1713
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La Jolla, CA
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Loma Linda, California 92354
Principal Investigator: Adrian Lavery
Phone: 909-558-5830
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Loma Linda, CA
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Minneapolis, Minnesota 55404
Principal Investigator: Andrea Lampland, MD
Phone: 651-220-6907
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Minneapolis, MN
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Philadelphia, Pennsylvania 19104
Principal Investigator: Sam Parry, MD
Phone: 215-490-2089
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Philadelphia, PA
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Pittsburgh, Pennsylvania 15261
Principal Investigator: Debra Bogen, MD
Phone: 412-692-7750
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Vancouver, British Columbia
Principal Investigator: Wee-Shian Chan, MD
Phone: 1-604-875-2000 ext. 5625
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Vancouver,
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