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

• Status: Completed
• Trial end date: 2016-10-20
• Target enrollment: 0
• Participant gender: Female

Summary

This study evaluates whether L-Alanyl-L-Glutamine can reduce the incidence, extent and severity of adhesions after myomectomy. Half of the participants will receive L-Alanyl-L-Glutamine and the other half of participants will receive a saline placebo at the time of myomectomy.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Temple Therapeutics BV

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