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Gender Disparity and Hormones in Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT02036879
Recruitment Status : Completed
First Posted : January 15, 2014
Last Update Posted : August 31, 2020
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) Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 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
Actual Study Start Date : February 2014
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 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) ]


Information from the National Library of Medicine

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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


Locations
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United States, Texas
Children's Medical Center
Dallas, Texas, United States, 75207
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Raksha Jain, MD, MSCI UT Southwestern Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Raksha Jain, Assistant Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02036879    
Other Study ID Numbers: STU 072013-079
First Posted: January 15, 2014    Key Record Dates
Last Update Posted: August 31, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Raksha Jain, University of Texas Southwestern Medical Center:
Cystic Fibrosis
Loestrin
Hormone
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Norethindrone
Norethindrone Acetate
Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination
Estradiol
Ethinyl Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptives, Oral, Combined
Contraceptives, Oral, Hormonal
Contraceptives, Oral, Sequential