Study for Breastfeeding Females

ICON Early Phase Services is conducting a research study for healthy breastfeeding females ages 18 and older. The purpose of this study is to determine whether an FDA approved drug (used to treat adults with type 2 diabetes) is present in breastmilk of breastfeeding women, and to estimate the amount of study drug that could reach the nursing baby via breastmilk. This will provide information to women and health care providers when selecting appropriate treatment for type 2 diabetes during breastfeeding. If you qualify for the study, you will receive the study drug once daily for 10 days in tablet form for oral (by mouth) intake.

Click here to make an appointment for NO 0009-0537

Or call 210-225-5437 for more information 

Vital signs, ECGs, physical examinations, drug and alcohol testing will be performed. Blood, breast milk, and urine samples will also be obtained during this study. 

Participants will complete:

  • Information visit
  • Screening visit
  • 3 Non-Consecutive overnights
  • 8 home nurse visits
  • 2 phone calls
  • 1 follow up visit

For more information, see below. 

Qualified participants may be compensated up to $4,100 for time and travel for completion of this study.

 

STUDY DATES

*Dates will be made on an individualized basis. Cohort 1 - EXAMPLE DATES
1st Admit - Day -1 at clinic Oct 11, 2021
Discharge - Day 1 at clinic Oct 12
Day 2 at home dose Oct 13
Day 3 at home dose Oct 14
Day 4 at home dose Oct 15
Day 5 at home dose Oct 16
Day 6 at home dose Oct 17
Day 7 at home dose Oct 18
Day 8 at home dose Oct 19
Day 9 at home dose am Oct 20
2nd Admit - Day 9 at clinic Oct 20
Day 10 at clinic Oct 21
Discharge - Day 11 at clinic Oct 22
Day 25 phone call Nov 05
Day 39 phone call Nov 19
Day 47 last study visit at clinic Nov 27

 

If you are able to answer “YES” to the following statements, you may qualify for this study. 

  • I am a healthy female 18 years or older, meaning no significant medical conditions
  • I am currently breastfeeding my baby and the majority of the baby’s intake is from breastfeeding
  • I have given birth at least 3 months prior to the screening visit
  • My BMI is between 20 and 32.4 kg/m2   
  • I am willing to refrain from breastfeeding (for a minimum of 47 days) and use a breast pump to collect the breast milk during the study
  • I have not participated in a clinical trial within 60 days (or 5 half-lives) prior to screening
  • I agree to use an effective method of contraception throughout the study
  • I have suitable veins for multiple blood samples
  • I am able to communicate effectively in English with the study personnel

Screening Reminders-

  • If taking medications, bring them to your screening appointment.
  • Bring a valid, non-expired photo ID with you when you attend your screening visit.  We accept a government issued identification card such as a driver's license, state issued ID card, military ID or passport.  You will be required to show this same photo ID at all study visits.
  • Arrive 30 minutes before your appointment to complete paper work.
Reference
NO 0009-0537
Name
Healthy Breastfeeding Females
Details
Appointments Available! $200 Refer-A-Friend bonus available.
Gender
Female
Payment amount
Up to $4,100
Age
18 and older -