A Clinical Study of Alanyl-Glutamine for Reduction of Post-Myomectomy Adhesions

Launched by TEMPLE THERAPEUTICS BV · Oct 3, 2012

Keywords

ClinConnect Summary

The myriad medical and financial burdens of post-operative adhesions are well documented; however, treatment options are limited and controversial. Implantable physical barriers to prevent adhesions are commercially available, but most trials have failed to demonstrate compelling evidence to support widespread use. In recent years, advances have been made in our understanding of the cellular mechanisms underlying adhesiogenesis, raising the prospect of targeting these pathways to prevent post-surgical adhesions. However, to date, no drug has received regulatory approval for this purpose in ...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Subjects are female
• • Subjects are 18 years of age or older at the time of consent
• • Subjects have a BMI between 17-40
• • Subjects must have signed informed consent form
• • Subjects have a preoperative diagnosis of uterine fibroids and plan to have a myomectomy completed surgically as part of their standard of care
• • Subjects must have a physical examination and compliance assessment
• Exclusion Criteria:
• • Subjects whose BMI is outside the range of 17-40
• • Subjects participating in another clinical trial with a drug or device
• • Subjects who have participated in a clinical trial with a drug or device within 30 days prior to this study
• • Subjects with suspected or diagnosed pregnancy
• • Subjects with suspected intraabdominal infection
• • Subjects who are immunocompromised
• • Subjects diagnosed with cancer
• • Subjects treated with hemostatic agents (e.g. fibrin sealant, collagen, oxidized cellulose)
• • Subjects treated with adhesion prevention agents other than the Anti-Adhesion product (APP) (e.g. Intergel ® Adhesion Prevention Solution, Seprafilm ® Membrane)
• • Subjects taking anti-epileptic medication
• • Subjects who have been treated with Methotrexate or other chemotherapeutics agents
• • Subjects with an American Fertility Society score of Stage D at the time of myomectomy as determined by the surgeon
• • Positive viral serology screening results for hepatitis B surface antigen, antibodies to hepatitis C virus or human immunodeficiency