Gender Disparity and Hormones in Cystic Fibrosis

Study ID
STU 072013-079

Cancer Related

Healthy Volunteers

Study Sites

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

Ashley Keller

Principal Investigator
Raksha Jain, M.D.

Official Title

Gender Disparity and Hormones in Cystic Fibrosis

Brief Overview

The objective of this study is to investigate the impact of hormones on lung disease in
Cystic Fibrosis (CF) patients. Due to improved therapies, CF patients are living longer and
healthier lives than they did 20 years ago. However, females have been shown to have a
survival disadvantage. The median life expectancy is 33 in women and 37 in men with CF. The
hypothesis is that estrogen and/or progesterone negatively impact lung health in CF.
Therefore, understanding the impact of sex hormones (including the use of birth control
pills) on the disease process is increasingly important. The purpose of this study is to
determine if lung function, respiratory symptoms, or various markers of lung health change
during different phases of the natural ovulatory cycle in order to understand if estrogen or
progesterone hormones are impacting the disease relative to fluctuations in men with stable
testosterone levels. The research objectives of this project are to:

- Determine if lung function, respiratory symptoms, or various markers of lung health
change during different hormonal phases of the ovulatory cycle in women.

- Determine if men change lung function, respiratory symptoms, or various markers of lung
health over time.

- Determine if oral contraceptive pills in women stabilize fluctuations in symptoms and
improve lung health.

Participant Eligibility

Inclusion Criteria:

- 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.

Exclusion Criteria for Main Study:

- Women who are pregnant, breast feeding, or who have had an oophorectomy.

- Women who have received a hormone contraceptive injection (such as Depo Provera)
within the last 3 months.

Exclusion Criteria for Substudy:

- Men

- Women who have a history of breast cancer, abnormal vaginal bleeding, liver disease,
coronary artery disease, cerebrovascular disease, uncontrolled hypertension, diabetes
mellitus with vascular disease, or have had a stroke, heart attack, or blood clot
within the past year, due to a possible reaction to Loestrin.

- Women who currently smoke cigarettes, due to the increased risk of serious
cardiovascular events with Loestrin use.