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Hormone Therapy
Estrogen Supplementation for Cystic Fibrosis (STURDY Trial)
Phase 4
Recruiting
Led By Malinda Wu, MD, MSc
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All of above and <35 years old
CF Diagnosis
Must not have
Use of chronic systemic glucocorticoids
Currently in pulmonary exacerbation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up evaluated at completion of study, approximately two years
Awards & highlights
Summary
This trial studies how estrogen skin patches affect bone health in young women with cystic fibrosis. Participants will use the patches regularly and undergo various health assessments. The goal is to see if this treatment can improve their bone health and quality of life. Estrogen replacement is recommended for female patients with CF-related bone disease to restore bone mineral density.
Who is the study for?
This trial is for young women with cystic fibrosis who have low estrogen levels, are not pregnant, and agree to use non-estrogen contraception. They should be planning to maintain their current level of estrogen supplementation throughout the study and must be at least two years post their first menstrual cycle.
What is being tested?
The study examines how hormonal contraception affects bone health in CF patients and tests the feasibility of transdermal estradiol (estrogen skin patches). Participants will undergo blood tests, questionnaires, x-rays, and DXAs over a year to monitor changes in bone health.
What are the potential side effects?
Potential side effects may include skin irritation from patches, hormone-related changes such as mood swings or weight gain. Estrogen can also increase the risk of blood clots; however specific side effects related to this trial are not detailed.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I meet all the criteria mentioned and am under 35 years old.
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I have been diagnosed with cystic fibrosis.
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I plan to keep my estrogen supplementation the same throughout the study.
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I have had at least one menstrual cycle.
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I have symptoms of low estrogen or my blood test shows low estrogen levels.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am on long-term steroid medication.
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I am currently experiencing a worsening of my lung condition.
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I cannot use skin patches that deliver estrogen.
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I have a history or condition that increases my risk of blood clots.
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I am currently taking estrogen or estrogen-containing pills.
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I have had a lung or liver transplant.
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I have taken antibiotics for a lung issue in the last 4 weeks.
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I cannot or will not use non-estrogen birth control methods.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ evaluated at completion of study, approximately two years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~evaluated at completion of study, approximately two years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Change in quality of life as assessed by Cystic Fibrosis Respiratory Symptom Diary - Chronic Respiratory Infection Symptom Score (CFRSD-CRISS) questionnaire
Change in serum C-terminal telopeptide of type I collagen (CTX-1) levels (pg/mL)
Change in serum procollagen type I intact N-terminal propeptide (P1NP) levels (mcg/L)
Other outcome measures
Acceptability as determined by participant report
Study procedure completion rate
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Transdermal Estradiol/Cyclic ProgesteroneExperimental Treatment2 Interventions
Participants will apply transdermal estradiol patches (0.1 mg/day) weekly for 12 months following baseline study visits. Participants not already using a progesterone-containing contraceptive will also take progesterone (200 mg) for 10 days per month.
Group II: Observational StudyActive Control1 Intervention
Participants will complete three study visits (baseline, 6 months, and 12 months) involving DXAs (bone density assessment), x-rays, blood draws, and questionnaires.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Progesterone
2013
Completed Phase 4
~4510
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Cystic Fibrosis (CF) include CFTR modulators, inhaled hypertonic saline, DNase, and antibiotics. CFTR modulators, such as ivacaftor and lumacaftor, target the defective CFTR protein to improve its function, thereby enhancing chloride transport and reducing mucus buildup.
Inhaled hypertonic saline helps to hydrate and clear thick mucus from the airways, while DNase breaks down DNA in the mucus to reduce its viscosity. Antibiotics are used to treat and prevent lung infections.
These treatments are crucial for CF patients as they address the underlying issues of mucus clearance and infection control, improving lung function and quality of life. Transdermal estradiol, being studied for its impact on bone health, may also influence mucus clearance by modulating estrogen levels, which have been shown to affect airway surface liquid volume and calcium signaling in CF patients.
From pipeline to patient: new developments in cystic fibrosis therapeutics.Targeting the Root Cause of Cystic Fibrosis.17beta-Estradiol inhibits Ca2+-dependent homeostasis of airway surface liquid volume in human cystic fibrosis airway epithelia.
From pipeline to patient: new developments in cystic fibrosis therapeutics.Targeting the Root Cause of Cystic Fibrosis.17beta-Estradiol inhibits Ca2+-dependent homeostasis of airway surface liquid volume in human cystic fibrosis airway epithelia.
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,307 Previous Clinical Trials
14,861,834 Total Patients Enrolled
20 Trials studying Cystic Fibrosis
7,119 Patients Enrolled for Cystic Fibrosis
Cystic Fibrosis FoundationOTHER
192 Previous Clinical Trials
37,664 Total Patients Enrolled
185 Trials studying Cystic Fibrosis
34,767 Patients Enrolled for Cystic Fibrosis
Malinda Wu, MD, MScPrincipal InvestigatorJohns Hopkins University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I meet all the criteria mentioned and am under 35 years old.It has been over 2 years since my first period.I am on long-term steroid medication.I am currently experiencing a worsening of my lung condition.I have been diagnosed with cystic fibrosis.I started my CFTR modulator treatment between 1 and 8 weeks ago.I plan to keep my estrogen supplementation the same throughout the study.I cannot use skin patches that deliver estrogen.Your vitamin D levels are very low (less than 6 ng/mL).I have a history or condition that increases my risk of blood clots.I am currently taking estrogen or estrogen-containing pills.I have had a lung or liver transplant.I am taking medication for osteoporosis, like bisphosphonates or teriparatide.I have had at least one menstrual cycle.I have symptoms of low estrogen or my blood test shows low estrogen levels.I have taken antibiotics for a lung issue in the last 4 weeks.You have a condition that causes bone loss, like lactation.I cannot or will not use non-estrogen birth control methods.
Research Study Groups:
This trial has the following groups:- Group 1: Observational Study
- Group 2: Transdermal Estradiol/Cyclic Progesterone
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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