BridgeMD
New treatment option for Cystic Fibrosis
Official title Estrogen Supplementation and Bone Health in Women With CF
ClinicalTrials.gov ID: NCT05704036
What this study is testing
What is Transdermal estrogen?
Transdermal estrogen is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for cystic fibrosis.
Also referred to as Transdermal estradiol, Climara.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this study is to learn about the role of estrogen and other hormones in bone development in adolescent and young adult women with cystic fibrosis (CF). The study has two main components, an observational study and a feasibility sub-study.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 100, women only
You may be able to join if
- Observational Study:
- CF Diagnosis
- Females who have had at least 1 menstrual cycle
- Planning to use same formulation of estrogen supplementation (or none) for duration of study
You likely can't join if
- Use of anti-osteoporosis therapy including anti-resorptives such as bisphosphonates or anabolic agents such as teriparatide or denosumab
- Conditions in which bone loss is known to be present or expected to occur, such as lactation
- Pregnant or planning to become pregnant
- In the opinion of the CF care team or study investigators participant should not participate in the study
- Inability to provide informed consent/assent Feasibility Sub-Study: Inclusion Criteria:
- All of above and
See the full eligibility criteria
- Observational Study:
- CF Diagnosis
- Females who have had at least 1 menstrual cycle
- Planning to use same formulation of estrogen supplementation (or none) for duration of study
- Use of anti-osteoporosis therapy including anti-resorptives such as bisphosphonates or anabolic agents such as teriparatide or denosumab
- Conditions in which bone loss is known to be present or expected to occur, such as lactation
- Pregnant or planning to become pregnant
- In the opinion of the CF care team or study investigators participant should not participate in the study
- Inability to provide informed consent/assent Feasibility Sub-Study: Inclusion Criteria:
- All of above and
- \<35 years old
- At least 2 years after first menstrual cycle
- Symptoms of low estrogen and/or low serum estradiol levels (\< 50 pg/mL) Exclusion Criteria:
- All of above and
- Contraindications to transdermal estradiol
- Current use of systemic estrogen (such as estrogen-containing oral contraceptive pill)
- Previous lung or liver transplant
- Use of chronic systemic glucocorticoids
- Severe vitamin D deficiency (serum 25(OH)D \< 6 ng/mL)
- Conditions increasing risk of clot: history of previous deep vein thrombus or pulmonary embolism, current immobility, current peripherally inserted central catheter or mediport, known hypercoagulable condition
- Baseline study visit falls between 1 and 8 weeks after initiation of CF transmembrane receptor (CFTR) modulator
- Currently in pulmonary exacerbation
- Recent antibiotic use within the past 4 weeks for an acute pulmonary exacerbation
- Unwilling or unable to use a non-estrogen containing method of contraception such as barrier, abstinence, or progesterone-only method
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 0 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.