Pilot E2 for Hypogonadal Women With CFBD

Phase 4 Withdrawn Emory University

RandomizedParallel-groupDouble-blindTreatment

Summary

The study is a prospective, double blinded, placebo controlled, randomized study to evaluate the effects of daily oral estrogen supplements on bone health, sexual and reproductive health, quality of life and markers of inflammation and lung function when given to hypogonadal women with Cystic Fibrosis related Bone Disease (CFBD).

Timeline

Start: 2019-04
Primary completion: 2021-06
Completion: 2021-06

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

Stopped (Enrollment): “Issues with Recruitment.”

paper Due to difficulty recruiting the planned 52 subjects, the trial was closed for recruitment and no subjects were randomized. PMID 34412687 ↗

Publications

Wu M, Tirouvanziam R, Arora N, Tangpricha V. Findings from a feasibility study of estradiol for hypogonadal women with cystic fibrosis-related bone disease. Pilot Feasibility Stud. 2021 Aug 19;7(1):160. doi: 10.1186/s40814-021-00897-x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Estradiol	Other / unclassified	2 mg	Oral