A Clinical Study of Alanyl-Glutamine for Reduction of Post-Myomectomy Adhesions (NCT01701193) | Clinical Trial Compass
CompletedPhase 1/2
A Clinical Study of Alanyl-Glutamine for Reduction of Post-Myomectomy Adhesions
Ukraine47 participantsStarted 2015-02-15
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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
What they're measuring
1
Number of Participants in Which Adhesions Were Prevented.