The TELO-SCOPE Study: Attenuating Telomere Attrition With Danazol. Is There Scope to Dramatically Improve Health Outcomes for Adults and Children With Pulmonary Fibrosis

Exclusion Criteria

• •1. Actively or imminently listed for lung transplantation.
• •2. Undergone, awaiting, or likely to require bone marrow transplantation within 12 months.
• •3. Concurrent enrolment in another study.
• •4. Females with a positive pregnancy test at screening or currently breastfeeding.
• •5. Pelvic infection.
• •6. Past jaundice with oral contraceptives.
• •7. Undiagnosed abnormal genital bleeding.
• •8. Undiagnosed ovarian/uterine masses
• •9. Any history of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next 12 months.
• •10. History of androgen-dependent tumour.
• •11. Any condition other than PF that, in the opinion of the investigator, is likely to result in the death of the participant within the next 12 months.
• •12. History of end-stage liver disease or ALT or AST \> 3 times the upper limit of normal.
• •13. History of end-stage kidney disease requiring dialysis.
• •14. Markedly impaired cardiac function.
• •15. Known increased risk of or history of thromboembolism (e.g. Factor V Leiden, Protein C or S deficiency).
• •16. Uncontrolled hypertension.
• •17. Uncontrolled lipoprotein disorder.
• •18. Poorly-controlled diabetes mellitus.
• •19. History of marked or persistent androgenic reaction to previous gonadal steroid therapy.
• •20. History of epilepsy induced or worsened by previous gonadal steroid therapy.
• •21. History of raised intracranial pressure.
• •22. Known intolerance to danazol.
• •23. Porphyria.
• •24. Use of any of the following agents within 28 days before screening: danazol or other androgen therapy, warfarin or other anticoagulant, carbamazepine, phenytoin, investigational therapy, cytotoxic therapy, tacrolimus, cyclosporine.
• •25. Professional singer due to potential for voice change.
• •26. Competitive athletes.
• •27. Prostate specific antigen (PSA) above the upper limit of normal (adult males only).