RecruitingPhase 4NCT05704036

Estrogen Supplementation and Bone Health in Women With CF

Estrogen Supplementation and Bone Health in Women With CF (STURDY)


Sponsor

Johns Hopkins University

Enrollment

75 participants

Start Date

May 2, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 0 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Progesterone and a drug called Transdermal estrogen for people with cystic fibrosis and hypoestrogenism. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTransdermal estrogen

Transdermal estradiol 0.1 mg/day, applied once weekly

DRUGProgesterone

Progesterone 200 mg daily for 10 days/month, if participant is not on progesterone-containing contraceptive


Locations(1)

Johns Hopkins

Baltimore, Maryland, United States

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NCT05704036


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