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Trial record 25 of 200 for:    Recruiting, Not yet recruiting, Available Studies | "Cystic Fibrosis"

Gender Disparity and Hormones in Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT02036879
Recruitment Status : Recruiting
First Posted : January 15, 2014
Last Update Posted : January 8, 2015
Sponsor:
Information provided by (Responsible Party):
Raksha Jain, University of Texas Southwestern Medical Center

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis (CF) Drug: Loestrin (norethindrone acetate and ethinyl estradiol) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Gender Disparity and Hormones in Cystic Fibrosis
Study Start Date : December 2013
Estimated Primary Completion Date : December 2018


Arm Intervention/treatment
No Intervention: Main study

The main study is an observational study.

All women will be followed for one menstrual cycle (or approximately one month) 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 interventional sub-study.

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.

Experimental: Loestrin Optional Substudy
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.
Drug: Loestrin (norethindrone acetate and ethinyl estradiol)
This is an optional substudy that females participating in the main study can choose to participate in. Loestrin, an oral contraceptive or birth control pill, will be prescribed and taken daily for approximately 2 months.




Primary Outcome Measures :
  1. Change in percent predicted forced expiratory volume in 1 second (FEV1) [ Time Frame: Through Visit 5, if applicable (or approximately 3 months) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02036879


Contacts
Contact: Ashley Keller, MPH 214-648-2817 ashley.keller@utsouthwestern.edu

Locations
United States, Texas
Children's Medical Center Recruiting
Dallas, Texas, United States, 75207
Contact: Ashley Keller, MPH    214-648-2817    ashley.keller@utsouthwestern.edu   
Principal Investigator: Raksha Jain, MD, MSCI         
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Ashley Keller, MPH    214-648-2817    ashley.keller@utsouthwestern.edu   
Principal Investigator: Raksha Jain, MD, MSCI         
Sub-Investigator: David Finklea, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Raksha Jain, MD, MSCI UT Southwestern Medical Center

Responsible Party: Raksha Jain, Assistant Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02036879     History of Changes
Other Study ID Numbers: STU 072013-079
First Posted: January 15, 2014    Key Record Dates
Last Update Posted: January 8, 2015
Last Verified: January 2015

Keywords provided by Raksha Jain, University of Texas Southwestern Medical Center:
Cystic Fibrosis
Loestrin
Hormone

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Hormones
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Mestranol
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Norethindrone
Norethindrone acetate
Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination
Norinyl
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogens
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptives, Oral, Combined