Overview

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