A Study to Evaluate Sildenafil for the Treatment of Lymphatic Malformations

Exclusion Criteria

• •1. The participant has a medically unstable health status that may interfere with his/her ability to complete the study.
• •2. The participant presents with one or more of the following medical conditions: hepatic impairment; severe renal impairment; lymphedema conditions such as Milroy disease, Meige lymphedema, Hennekam syndrome, Njolstad syndrome, Aagenaes syndrome, and Fabry disease; hypotension or at risk for hypotension; seizures or history of seizures; any significant cardiovascular risk factors and any condition which requires participants to use nitric oxide donors or nitrates in any form; underlying anatomic or vascular risk factors for developing non-arteritic anterior ischemic optic neuropathy (NAION) including low ocular cup to disc ratio, age over 10, diabetes, hypertension, coronary artery disease, hyperlipidemia, and smoking. (Participants with Down syndrome, Turner syndrome, and Noonan syndrome will be considered on a case-by-case basis).
• •3. The participant has received at least one of the following medications contraindicated in association with sildenafil within 15 days of inclusion: Alprostadil, Azole antifungals, Clarithromycins, Conivaptan, Delavirdine, Erythromycins, Fluvoxamine, Grapefruit, Imatinib, Nefazodone, Nitrates/sodium thiosulfate, Non-selective and selective alpha blockers, Protease inhibitors, Rufinamide, Tadalafil, Telithromycin, Vardenafil, Yohimbe, Yohimbine, Amifostine, Lapatinib, Warfarin
• •4. The participant requires concomitant use of potent cytochrome P450 3A4 inhibitors (such as ketoconazole, itraconazole, erythromycin, saquinavir) or concomitant use of ritonavir.
• •5. The patient has had extensive prior surgery or sclerotherapy to treat LM such that scarring may interfere with the treatment effect of sildenafil.
• •6. The participant has previously been administered treatment for LMs or surgical procedures have been performed to remove the index LMs.
• •7. Participant is currently pregnant or considering becoming pregnant in the next 20 weeks.
• •8. The participant is known to have an allergy to sildenafil.
• •9. Ulcerated or currently infected LMs with pain.
• •10. Diagnosis of the soft tissue tumor as LM is not clinically certain.
• •11. The participant is participating in another clinical study.
• •12. The participant has a history of priapism or is diagnosed with sickle cell anemia or any other disorder which may predispose to priapism.
• •13. The investigator may declare any subject ineligible for a valid medical reason.