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

NCT01701193 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2021-05-07

Study results available
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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.

Conditions

  • Pelvic Adhesions

Interventions

DRUG

L-Alanyl/L-Glutamine

Sterile solution of L-Alanyl-L-Glutamine, 400mg/mL in water for injection. It is dosed at 1g/kg of body weight and is instilled into the peritoneum at the time of surgery. The active ingredient, glutamine, is a conditionally essential amino acid component of nutritional supplements.

DRUG

Physiologic saline

Placebo

Sponsors & Collaborators

  • Temple Therapeutics BV

    lead INDUSTRY

Principal Investigators

  • Donna Chizen, MD, FRCSC · University of Saskatchewan

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-15
Primary Completion
2016-10-20
Completion
2016-10-20

Countries

  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01701193 on ClinicalTrials.gov