NCT02911844

Estrogen Receptor Antagonist in Patients With Pulmonary Arterial Hypertension

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this clinical trial is to examine the feasibility and effects of fulvestrant in post-menopausal women with pulmonary arterial hypertension (PAH). The study will evaluate how well the drug is tolerated. The study will evaluate changes in circulating hematopoietic progenitor cells, plasma hormone levels, NT-proBNP, and other plasma biomarkers after the administration of fulvestrant. Changes in tricuspid annular plane systolic excursion, stroke volume index, right ventricular fractional area change, and other echo parameters after fulvestrant administration will be evaluated as well as changes in distance walked in six minutes.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	Fulvestrant	Fulvestrant 500 mg administered intramuscularly into the buttocks slowly as two 5 mL injections, one in each buttock, on days 0, 14, 28 and 56. Fulvestrant 250 mg (one 5 mL injection) will be used in patients with Child-Pugh Class B liver disease.

Timeline

• Start date: 2017-04-10
• Primary completion: 2018-12-05
• Completion: 2018-12-05
• First posted: 2016-09-22
• Last updated: 2019-12-09
• Results posted: 2019-12-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study