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NCT05704036 · ClinicalTrials.gov registry record · Phase 4
Estrogen Supplementation and Bone Health in Women With CF
A Phase 4 study of Cystic Fibrosis and Hypoestrogenism, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 75
- Enrollment target
- 1
- Study location
NCT05704036: Recruiting Phase 4 study of Cystic Fibrosis and Hypoestrogenism, sponsored by Johns Hopkins University.
NCT05704036 is a Phase 4 study of Cystic Fibrosis and Hypoestrogenism that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 75 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (58% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05704036, a Phase 4 study of Cystic Fibrosis and Hypoestrogenism, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 75 participants
- Enrollment target
- 1
- Study location
Study Summary
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. The main questions it aims to answer are: * How do different forms of hormonal contraception (e.g. birth control pill or other progesterone only methods) impact bone health? * Is a study of transdermal estradiol (estrogen skin patches) feasible in this group? * How does transdermal estradiol impact bone health and quality of life? Participants in the observational study will have three study visits (baseline, 6 months, and 12 months). At all visits, participants will have blood drawn and will complete questionnaires. At the baseline and 12 month visits, participants will additionally have x-rays and DXAs (bone density assessment). Between visits, participants will complete brief questionnaires. Researchers will compare various measurements over time to assess the impact of different forms of hormonal contraception. Participants in the feasibility sub-study will apply transdermal estradiol patches once weekly for 12 months, fill out brief quality-of-life surveys in between study visits, and complete blood draws and questionnaires at four study visits (baseline, 3 months, 6 months, and 12 months). The participants will also have x-rays and DXAs performed at the baseline and 12 month visits. Researchers will examine changes in various measurements to determine the impact of transdermal estradiol.
Conditions Studied
Interventions
- DRUG Progesterone
- DRUG Transdermal estrogen
Study Locations (1)
Maryland
- Johns Hopkins - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2023-05-02 |
| Est. Completion | 2027-01 |
| Phase | Phase 4 |
What NCT05704036 shows while recruiting
NCT05704036 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (58% lower).
The record links to 2 conditions, with Cystic Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which Progesterone is the first listed.
NCT05704036 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05704036 about?
NCT05704036 is a clinical study titled "Estrogen Supplementation and Bone Health in Women With CF". 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. The main questions it aims to answer are: * How ...
What is the current status of trial NCT05704036?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 75 participants. The study started on 2023-05-02. Estimated completion is 2027-01.
What conditions does trial NCT05704036 study?
This clinical trial studies the following conditions: Cystic Fibrosis, Hypoestrogenism.
What interventions are being tested in trial NCT05704036?
The interventions under investigation include: Progesterone (DRUG), Transdermal estrogen (DRUG).
Who is sponsoring clinical trial NCT05704036?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05704036 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05704036's enrollment target sits among peer trials
75 75th of 169 higher than 95 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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