Trial Outcomes & Findings for A Clinical Study of Alanyl-Glutamine for Reduction of Post-Myomectomy Adhesions (NCT NCT01701193)

Last Updated: 2021-05-07

Results Overview

The American Fertility Society (AFS) grading system for adhesions was used to assess incidence of adhesions. Adhesion prevention was determined through grading of adhesions at the time of myomectomy (initial surgery) and at the time of second look surgery and compared.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

47 participants

Primary outcome timeframe

6-8 weeks

Results posted on

2021-05-07

Participant Flow

This was a single-center study at a private hospital clinic. Recruitment was between February 2015 and October 2016. Subjects were adult women planned for myomectomy with a scheduled clinically necessary second look laparoscopy. The study and consent form were approved by the Institutional Review Board/Ethics Committee and the Investigator's IRB/EC (Ethics Committee of Kharkiv City Clinical Multi-field Hospital,Kharkiv, Ukraine). Participants were not compensated to participate in this trial.

Participant milestones

Participant milestones
Measure	L-Alanyl/L-Glutamine- Laparoscopic Participants receiving intraperitoneal administration of L-Alanyl-L-Glutamine at the time of laparoscopic myomectomy. 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.	Physiological Saline- Laparoscopic Participants receiving intraperitoneal administration of physiological saline at the time of laparoscopic myomectomy. Physiologic saline: Placebo	L-Alanyl/L-Glutamine- Laparotomy Participants receiving intraperitoneal administration of L-Alanyl-L-Glutamine at the time of myomectomy (laparotomy).	Physiological Saline- Laparotomy Participants receiving intraperitoneal administration of physiological saline at the time of myomectomy (laparotomy).
Overall Study STARTED	18	19	5	5
Overall Study COMPLETED	15	17	4	3
Overall Study NOT COMPLETED	3	2	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	L-Alanyl/L-Glutamine- Laparoscopic Participants receiving intraperitoneal administration of L-Alanyl-L-Glutamine at the time of laparoscopic myomectomy. 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.	Physiological Saline- Laparoscopic Participants receiving intraperitoneal administration of physiological saline at the time of laparoscopic myomectomy. Physiologic saline: Placebo	L-Alanyl/L-Glutamine- Laparotomy Participants receiving intraperitoneal administration of L-Alanyl-L-Glutamine at the time of myomectomy (laparotomy).	Physiological Saline- Laparotomy Participants receiving intraperitoneal administration of physiological saline at the time of myomectomy (laparotomy).
Overall Study Withdrawal by Subject	2	2	1	2
Overall Study Adverse Event	1	0	0	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	L-Alanyl/L-Glutamine- Laparoscopic n=18 Participants Participants receiving intraperitoneal administration of L-Alanyl-L-Glutamine at the time of laparoscopic myomectomy. 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.	Physiological Saline- Laparoscopic n=19 Participants Participants receiving intraperitoneal administration of physiological saline at the time of laparoscopic myomectomy. Physiologic saline: Placebo	L-Alanyl/L-Glutamine- Laparotomy n=5 Participants Participants receiving intraperitoneal administration of L-Alanyl-L-Glutamine at the time of myomectomy (laparotomy). 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.	Physiological Saline- Laparotomy n=5 Participants Participants receiving intraperitoneal administration of physiological saline at the time of myomectomy (laparotomy). Physiologic saline: Placebo	Total n=47 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=18 Participants	0 Participants n=19 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=47 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=18 Participants	19 Participants n=19 Participants	5 Participants n=5 Participants	5 Participants n=5 Participants	47 Participants n=47 Participants
Age, Categorical >=65 years	0 Participants n=18 Participants	0 Participants n=19 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=47 Participants
Sex: Female, Male Female	18 Participants n=18 Participants	19 Participants n=19 Participants	5 Participants n=5 Participants	5 Participants n=5 Participants	47 Participants n=47 Participants
Sex: Female, Male Male	0 Participants n=18 Participants	0 Participants n=19 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=47 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
BMI (kg/m^2)	23.5 kg/m^2 STANDARD_DEVIATION 4.3 • n=18 Participants	22.3 kg/m^2 STANDARD_DEVIATION 3.0 • n=19 Participants	24.5 kg/m^2 STANDARD_DEVIATION 7.9 • n=5 Participants	23.5 kg/m^2 STANDARD_DEVIATION 3.5 • n=5 Participants	23.5 kg/m^2 STANDARD_DEVIATION 0.9 • n=47 Participants
Temperature (Degrees Celsius)	36.7 Degrees Celsius STANDARD_DEVIATION 0.1 • n=18 Participants	36.3 Degrees Celsius STANDARD_DEVIATION 0.1 • n=19 Participants	36.7 Degrees Celsius STANDARD_DEVIATION 0.1 • n=5 Participants	36.6 Degrees Celsius STANDARD_DEVIATION 0.1 • n=5 Participants	36.5 Degrees Celsius STANDARD_DEVIATION 0.2 • n=47 Participants
Heart rate (bpm)	79.8 beats per minute STANDARD_DEVIATION 8.6 • n=18 Participants	79.4 beats per minute STANDARD_DEVIATION 7.6 • n=19 Participants	79 beats per minute STANDARD_DEVIATION 1.8 • n=5 Participants	73 beats per minute STANDARD_DEVIATION 8.3 • n=5 Participants	77.8 beats per minute STANDARD_DEVIATION 3.2 • n=47 Participants
Systolic BP (mmHg)	113.9 mmHg STANDARD_DEVIATION 9.5 • n=18 Participants	113.9 mmHg STANDARD_DEVIATION 8.6 • n=19 Participants	117 mmHg STANDARD_DEVIATION 5.7 • n=5 Participants	110 mmHg STANDARD_DEVIATION 10 • n=5 Participants	113.7 mmHg STANDARD_DEVIATION 2.9 • n=47 Participants
Diastolic BP (mmHg)	70.0 mmHg STANDARD_DEVIATION 5.0 • n=18 Participants	70.3 mmHg STANDARD_DEVIATION 6.1 • n=19 Participants	71 mmHg STANDARD_DEVIATION 2.2 • n=5 Participants	67 mmHg STANDARD_DEVIATION 6.7 • n=5 Participants	69.6 mmHg STANDARD_DEVIATION 1.8 • n=47 Participants

PRIMARY outcome

Timeframe: 6-8 weeks

Population: The number of subjects in each study group (Control \[N=20\] and AG \[N=19\]) was lower at the second look laparoscopic (SLL) compared to the number of subjects originally enrolled in each study group. The difference between groups numbers is a result of dropouts, including subjects who failed criteria for SLL or who elected not to continue the study. The laparotomy group, given the small sample size, was primary used to gather safety data.

Outcome measures

Outcome measures
Measure	L-Alanyl/L-Glutamine- Laparoscopic n=15 Participants Participants receiving intraperitoneal administration of L-Alanyl-L-Glutamine at the time of laparoscopic myomectomy. 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.	Physiological Saline- Laparoscopic n=17 Participants Participants receiving intraperitoneal administration of physiological saline at the time of laparoscopic myomectomy. Physiologic saline: Placebo	L-Alanyl/L-Glutamine- Laparotomy n=4 Participants Participants receiving intraperitoneal administration of L-Alanyl-L-Glutamine at the time of myomectomy (laparotomy). 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.	Physiological Saline- Laparotomy n=3 Participants Participants receiving intraperitoneal administration of physiological saline at the time of myomectomy (laparotomy). Physiologic saline: Placebo
Number of Participants in Which Adhesions Were Prevented.	15 Participants	5 Participants	4 Participants	3 Participants

SECONDARY outcome

Timeframe: 8 weeks

Participants With Treatment-related Adverse Events as Assessed by Clinical Blood Work Abnormalities and Physical Examination.

Outcome measures

Outcome measures
Measure	L-Alanyl/L-Glutamine- Laparoscopic n=18 Participants Participants receiving intraperitoneal administration of L-Alanyl-L-Glutamine at the time of laparoscopic myomectomy. 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.	Physiological Saline- Laparoscopic n=19 Participants Participants receiving intraperitoneal administration of physiological saline at the time of laparoscopic myomectomy. Physiologic saline: Placebo	L-Alanyl/L-Glutamine- Laparotomy n=5 Participants Participants receiving intraperitoneal administration of L-Alanyl-L-Glutamine at the time of myomectomy (laparotomy). 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.	Physiological Saline- Laparotomy n=5 Participants Participants receiving intraperitoneal administration of physiological saline at the time of myomectomy (laparotomy). Physiologic saline: Placebo
Adverse Events, Adverse Drug Reactions and Clinical Laboratory Abnormalities.	3 Participants	6 Participants	1 Participants	1 Participants

Adverse Events

L-Alanyl/L-Glutamine- Laparoscopic

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Physiological Saline- Laparoscopic

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

L-Alanyl/L-Glutamine- Laparotomy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Physiological Saline -Laparotomy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	L-Alanyl/L-Glutamine- Laparoscopic n=18 participants at risk Participants receiving intraperitoneal administration of L-Alanyl-L-Glutamine at the time of laparoscopic myomectomy. 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.	Physiological Saline- Laparoscopic n=19 participants at risk Participants receiving intraperitoneal administration of physiological saline at the time of laparoscopic myomectomy. Physiologic saline: Placebo	L-Alanyl/L-Glutamine- Laparotomy n=5 participants at risk Participants receiving intraperitoneal administration of L-Alanyl-L-Glutamine at the time of myomectomy (laparotomy). 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.	Physiological Saline -Laparotomy n=5 participants at risk Participants receiving intraperitoneal administration of physiological saline at the time of myomectomy (laparotomy). Physiologic saline: Placebo
Gastrointestinal disorders Nausea	5.6% 1/18 • Number of events 1 • Adverse events were monitored for 8 weeks post-myomectomy. Safety was assessed though the incidence of adverse drug events (AE) and clinical lab abnormalities. The laparotomy arms were included for safety analysis, and laboratory assessments were conducted at the time of myomectomy and at SLL for all patients that enrolled and completed the study.	15.8% 3/19 • Number of events 3 • Adverse events were monitored for 8 weeks post-myomectomy. Safety was assessed though the incidence of adverse drug events (AE) and clinical lab abnormalities. The laparotomy arms were included for safety analysis, and laboratory assessments were conducted at the time of myomectomy and at SLL for all patients that enrolled and completed the study.	0.00% 0/5 • Adverse events were monitored for 8 weeks post-myomectomy. Safety was assessed though the incidence of adverse drug events (AE) and clinical lab abnormalities. The laparotomy arms were included for safety analysis, and laboratory assessments were conducted at the time of myomectomy and at SLL for all patients that enrolled and completed the study.	0.00% 0/5 • Adverse events were monitored for 8 weeks post-myomectomy. Safety was assessed though the incidence of adverse drug events (AE) and clinical lab abnormalities. The laparotomy arms were included for safety analysis, and laboratory assessments were conducted at the time of myomectomy and at SLL for all patients that enrolled and completed the study.
Hepatobiliary disorders Elevated AST levels	5.6% 1/18 • Number of events 1 • Adverse events were monitored for 8 weeks post-myomectomy. Safety was assessed though the incidence of adverse drug events (AE) and clinical lab abnormalities. The laparotomy arms were included for safety analysis, and laboratory assessments were conducted at the time of myomectomy and at SLL for all patients that enrolled and completed the study.	10.5% 2/19 • Number of events 2 • Adverse events were monitored for 8 weeks post-myomectomy. Safety was assessed though the incidence of adverse drug events (AE) and clinical lab abnormalities. The laparotomy arms were included for safety analysis, and laboratory assessments were conducted at the time of myomectomy and at SLL for all patients that enrolled and completed the study.	0.00% 0/5 • Adverse events were monitored for 8 weeks post-myomectomy. Safety was assessed though the incidence of adverse drug events (AE) and clinical lab abnormalities. The laparotomy arms were included for safety analysis, and laboratory assessments were conducted at the time of myomectomy and at SLL for all patients that enrolled and completed the study.	0.00% 0/5 • Adverse events were monitored for 8 weeks post-myomectomy. Safety was assessed though the incidence of adverse drug events (AE) and clinical lab abnormalities. The laparotomy arms were included for safety analysis, and laboratory assessments were conducted at the time of myomectomy and at SLL for all patients that enrolled and completed the study.
Infections and infestations Elevated temperature	0.00% 0/18 • Adverse events were monitored for 8 weeks post-myomectomy. Safety was assessed though the incidence of adverse drug events (AE) and clinical lab abnormalities. The laparotomy arms were included for safety analysis, and laboratory assessments were conducted at the time of myomectomy and at SLL for all patients that enrolled and completed the study.	10.5% 2/19 • Number of events 2 • Adverse events were monitored for 8 weeks post-myomectomy. Safety was assessed though the incidence of adverse drug events (AE) and clinical lab abnormalities. The laparotomy arms were included for safety analysis, and laboratory assessments were conducted at the time of myomectomy and at SLL for all patients that enrolled and completed the study.	0.00% 0/5 • Adverse events were monitored for 8 weeks post-myomectomy. Safety was assessed though the incidence of adverse drug events (AE) and clinical lab abnormalities. The laparotomy arms were included for safety analysis, and laboratory assessments were conducted at the time of myomectomy and at SLL for all patients that enrolled and completed the study.	20.0% 1/5 • Number of events 1 • Adverse events were monitored for 8 weeks post-myomectomy. Safety was assessed though the incidence of adverse drug events (AE) and clinical lab abnormalities. The laparotomy arms were included for safety analysis, and laboratory assessments were conducted at the time of myomectomy and at SLL for all patients that enrolled and completed the study.
Renal and urinary disorders Elevated CPK levels	5.6% 1/18 • Number of events 1 • Adverse events were monitored for 8 weeks post-myomectomy. Safety was assessed though the incidence of adverse drug events (AE) and clinical lab abnormalities. The laparotomy arms were included for safety analysis, and laboratory assessments were conducted at the time of myomectomy and at SLL for all patients that enrolled and completed the study.	0.00% 0/19 • Adverse events were monitored for 8 weeks post-myomectomy. Safety was assessed though the incidence of adverse drug events (AE) and clinical lab abnormalities. The laparotomy arms were included for safety analysis, and laboratory assessments were conducted at the time of myomectomy and at SLL for all patients that enrolled and completed the study.	20.0% 1/5 • Number of events 1 • Adverse events were monitored for 8 weeks post-myomectomy. Safety was assessed though the incidence of adverse drug events (AE) and clinical lab abnormalities. The laparotomy arms were included for safety analysis, and laboratory assessments were conducted at the time of myomectomy and at SLL for all patients that enrolled and completed the study.	0.00% 0/5 • Adverse events were monitored for 8 weeks post-myomectomy. Safety was assessed though the incidence of adverse drug events (AE) and clinical lab abnormalities. The laparotomy arms were included for safety analysis, and laboratory assessments were conducted at the time of myomectomy and at SLL for all patients that enrolled and completed the study.

Additional Information

Roger Pierson, PhD

University of Saskatchewan

Phone: 306-884-1059

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place