Cystic Fibrosis study: Transdermal estrogen vs Progesterone
Official title Estrogen Supplementation and Bone Health in Women With CF
ClinicalTrials.gov ID: NCT05704036
What this study is testing
What is Transdermal estradiol patch?
an investigational transdermal estrogen patch being studied for bone health in adolescent and young adult women with cystic fibrosis is designed to deliver estradiol through the skin to bind estrogen receptors and support bone formation
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 study wants to see how different hormonal birth‑control methods affect bone health and whether using estrogen skin patches is practical and safe for these women.
- Who it's for
- Teenage or young adult women who have cystic fibrosis and low estrogen levels.
- What's involved
- Participants will have regular blood draws, questionnaires, and bone scans; some will also use a weekly estrogen skin patch for a year and report quality‑of‑life surveys.
- Time commitment
- The study lasts 12 months with visits every 3‑6 months, plus occasional short surveys between visits.
- 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
- 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
- All of above and
- \<35 years old
See the full eligibility criteria
- 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
- All of above and
- \<35 years old
- At least 2 years after first menstrual cycle
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Baltimore, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.