Cystic Fibrosis (CF)Early Phase 1NCT02036879
Gender Disparity and Hormones in Cystic Fibrosis
A Early Phase 1 study testing Loestrin (norethindrone acetate and ethinyl estradiol) in people with Cystic Fibrosis (CF), run by University of Texas Southwestern Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis (CF)
- What is being tested?
- Loestrin (norethindrone acetate and ethinyl estradiol)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2014to Aug 2018
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Medical Center
Dallas, Texas, 75207
UT Southwestern Medical Center
Dallas, Texas, 75390
About this study
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.
- Conditions
- Cystic Fibrosis (CF)
- Being tested
- Loestrin (norethindrone acetate and ethinyl estradiol)
- Keywords
- Cystic Fibrosis, Loestrin, Hormone
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loestrin (norethindrone acetate and ethinyl estradiol)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Main study | No intervention | 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. |
| Loestrin Optional Substudy | Experimental | 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. Receives: Drug: Loestrin (norethindrone acetate and ethinyl estradiol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percent predicted forced expiratory volume in 1 second (FEV1)
Measured: Through Visit 5, if applicable (or approximately 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis (CF)Studies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raksha Jain, University of Texas Southwestern Medical Center
- Investigators
- Raksha Jain, MD, MSCI, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036879
- Sponsor's protocol ID
- STU 072013-079
- Status last verified
- Aug 2020
- First submitted
- 26 Dec 2013
- Last updated
- 31 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender Disparity and Hormones in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT02036879
- Acronym / sponsor ID
- STU 072013-079
- Conditions
- Cystic Fibrosis (CF)
- Keywords
- Cystic Fibrosis, Loestrin, Hormone
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 15 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Main study | No intervention | –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. |
| Loestrin Optional Substudy | Experimental | Drug: Loestrin (norethindrone acetate and ethinyl estradiol)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Loestrin Optional Substudy |
Primary outcome
Change in percent predicted forced expiratory volume in 1 second (FEV1)
Time frame: Through Visit 5, if applicable (or approximately 3 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raksha Jain, MD, MSCI principal investigator
University of Texas Southwestern Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Loestrin (norethindrone acetate and ethinyl estradiol) in people with Cystic Fibrosis (CF), run by University of Texas Southwestern Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in percent predicted forced expiratory volume in 1 second (FEV1) (time frame: Through Visit 5, if applicable (or approximately 3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2020.