Overview

Estrogen Patches for Adolescent and Young Adult Women With Cystic Fibrosis

Status:
Not yet recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to learn about the role of estrogen in bone development in adolescent and young adult women with cystic fibrosis (CF) and low estrogen levels. The main questions it aims to answer are: - 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 will apply transdermal estradiol patches (or placebo patches -- patches that look like the estradiol patches but do not contain any estradiol) once weekly for 12 months, fill out brief quality-of-life surveys twice per month, 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 (bone density assessment) performed at the baseline and 12 month visits. Researchers will compare changes in various measurements between the treatment and placebo groups to determine the impact of transdermal estradiol.
Phase:
Phase 4
Details
Lead Sponsor:
Johns Hopkins University
Collaborator:
Cystic Fibrosis Foundation
Treatments:
Estradiol
Estrogens
Progesterone