Gender Disparity and Hormones in Cystic Fibrosis
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| ClinicalTrials.gov Identifier: NCT02036879 |
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Recruitment Status :
Completed
First Posted : January 15, 2014
Last Update Posted : August 31, 2020
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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 |
| 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 |
|---|---|
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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. |
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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.
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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. |
- 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 |
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.
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
| United States, Texas | |
| Children's Medical Center | |
| Dallas, Texas, United States, 75207 | |
| UT Southwestern Medical Center | |
| Dallas, Texas, United States, 75390 | |
| 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 |
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Cystic Fibrosis Loestrin Hormone |
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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 Ethinyl Estradiol Norethindrone Norethindrone Acetate Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination Estradiol |
Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Contraceptive Agents, Hormonal Contraceptive Agents Reproductive Control Agents Contraceptive Agents, Female Contraceptives, Oral, Hormonal Contraceptives, Oral Contraceptives, Oral, Synthetic Contraceptives, Oral, Combined Contraceptives, Oral, Sequential |