Gender Disparity and Hormones in Cystic Fibrosis

Study ID
STU 072013-079

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern-Other
  • Clements University Hospital
  • UT Southwestern Ambulatory Services
  • Children's Medical Center (Dallas, Plano, Southlake)

Contact
Ashley Keller
214/648-2817
ashley.keller@utsouthwestern.edu

Principal Investigator
Raksha Jain

Summary

The main study is an observational study that will include cystic fibrosis patients who are greater or equal to 18 years of age. a total of 60 subjects may be consented at uTSW or Children's Medical Center.

all women will be followed for one menstrual cycle observationally off of any hormone supplementation. They will have 3 study visits corresponding to their menstrual cycle phases (menses, ovulation, and luteal).

Women participating in the main study may participate in the optional sub-study. Following a negative urine pregnancy test, women will be started on once daily oral Loestrin (1.5 mg norethindrone + 0.03 mg ethyl estradiol). They will be followed for two months on this agent and have 2 additional study visits.

Men participating in this study will be followed for 1 month observationally. They will have 3 study visits that correlate with the female arm of this study.

at study visits, patient will have blood drawn to confirm hormone levels, take CF related respiratory symptom questionnaires, provide a sputum sample to assess inflammatory biomarkers and bacterial density, provide sweat through a macroduct sweat test, and perform spirometry and a nasal saccharin test to gauge mucociliary clearance.

The primary endpoint is change in spirometry. Secondary endpoints are change in respiratory symptoms, bacteria in sputum, and nasal mucociliary clearance.

The estimated time for completion of this project is 5 years. it will take 3-4 years to identify, consent subjects, and to collect pertinent data. it will take 1-2 years to analyze the data and write appropriate manuscripts.

Participant Eligibility


* Male and female cystic fibrosis patients

* Must be greater than or equal to 18 years of age.

* All subjects must understand and sign the informed consent.

* Subjects must have the ability to read and write in English.

* Female subjects starting this study must be willing to use a double barrier method of birth control (such as condom or diaphragm) used with a spermicide (a substance that kills sperm), while participating in the study.