Phase 2
N=47
A Clinical Study of Alanyl-Glutamine for Reduction of Post-Myomectomy Adhesions
Pelvic Adhesions
Bottom Line
View on ClinicalTrials.gov: NCT01701193 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: Number of Participants in Which Adhesions Were Prevented. — 15; 5; 4; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- L-Alanyl/L-Glutamine (Drug); Physiologic saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Temple Therapeutics BV
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants in Which Adhesions Were Prevented. |
15; 5; 4; 3 | — |
| SECONDARY Adverse Events, Adverse Drug Reactions and Clinical Laboratory Abnormalities. |
3; 6; 1; 1 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01701193). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.