Efficacy and Dose Ranging Study of Seroguard

• Sponsor: Pharmasyntez (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03660787
• Collaborator: Cromos Pharma LLC (Industry)
• Enrollment: 114
• Locations: 14
• Arms: 4
• Actual Duration (Months): 8.7
• Patients Per Site: 8.1
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

This trial was a multi-center, double-blind, randomized, parallel group, placebo-controlled, phase II study in adult hospitalized female patients with the confirmed diagnosis of pelvic adhesive disease in Study centres in Russia.

Condition or Disease	Intervention/Treatment	Phase
Adhesion	Drug: Seroguard; Drug: Placebo	Phase 2

Detailed Description

In order to evaluate efficacy and safety of Seroguard, solution for IP administration, a study design meeting the set objectives was selected: prospective, multi-center, double-blind, randomized, parallel group, placebo-controlled study.

Given the fact that comparison with placebo is considered the best way to prove efficacy and safety of a drug and that currently there are no drugs with a similar mechanism of action at the pharmaceutical product market, a placebo-controlled, parallel group study design was selected.

A randomized, parallel group study design was chosen in order to ensure minimization of a selection bias.

Subjects were randomized into four groups (two groups of the test drug and two placebo groups corresponding to the two doses) to enable a comparison of Seroguard administration at two doses.

A double-blind study design was selected in order to ensure minimization of an outcome evaluation bias.

Study Design

• Study Type: Interventional
• Actual Enrollment: 114 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: The present study was conducted as a double blind trial. Neither a medical investigator, nor patients had access to the treatment assignment code in order to ensure the maximum objective evaluation of the primary endpoint. Blinding was performed in such a way that disclosing a randomization code of a certain subject excluded a disclosure of the code in general (i.e. the randomization code had no indication to the treatment group). However, there were no cases of the randomization code disclosure in the study
• Primary Purpose: Prevention
• Official Title: Phase II Multi-center Randomized Double-blind Placebo-controlled Efficacy and Dose Ranging Trial of the Drug Product Seroguard, Solution (JSC Pharmasyntez, Russia) Used for the Prevention of Pelvic Adhesions
• Actual Study Start Date: May 4, 2017
• Actual Primary Completion Date: Jan 23, 2018
• Actual Study Completion Date: Jan 23, 2018

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo, 1.5 mL/kg each subject received the placebo at the dose of 1.5 mL/kg of body weight;	Drug: Placebo; Saline
Placebo Comparator: Placebo, 2.4 mL/kg each subject received the placebo at the dose of 2.4 mL/kg of body weight;	Drug: Placebo; Saline
Experimental: Seroguard, 1.5 mL/kg each subject received the test drug at the dose of 1.5 mL/kg of body weight;	Drug: Seroguard; Seroguard 0.41 g/L solution
Experimental: Seroguard, 2.4 mL/kg each subject received the test drug at the dose of 2.4 mL/kg of body weight.	Drug: Seroguard; Seroguard 0.41 g/L solution

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Reduction of Adhesions Number by 3 or More [30±4 days after surgical intervention]

   The number of adhesions according to the first MRI data was compared to the number according to the data of second MRI

Secondary Outcome Measures

1. Change in Thickness of Pelvic Adhesions [30±4 days after surgery]

   The change from baseline was defined. It was evaluated by comparing baseline MRI data and repeated MRI data. Results were estimated according to scale from 0 to 3 where 0 - no adhesions, 1 - thin (filmy or filiform), 2 - marked, 3 - marked with an impaired passage through organs involved.

2. Number of Participants With Detection of Pelvic Organs Limited Mobility [30±4 days after surgery]

   The frequency was estimated based on transvaginal ultrasound results

3. Number of Participants With Detection of Hyperechoic Linear Lesions Post Surgery [30±4 days after surgery]

   The frequency was estimated based on transvaginal ultrasound results

4. Change in Number of Participants in Detecting Pelvic Organs Limited Mobility [30±4 days after surgery]

   Absolute change of count of participants was measured with detecting pelvic organs limited mobility from the baseline

5. Change Number of Participants in Detecting Hyperechoic Linear Lesions [30±4 days after surgery]

   Frequency of detecting after repeated transvaginal ultrasound results was compared to baseline indications (4 or more)

6. Number of Participants With Detection of no Ultrasound Signs of Pelvic Adhesive Disease Post Surgery [30±4 days after surgery]

   No limited mobility of pelvic organs and no hyperechoic linear lesions should be shown

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Female patients aged from 18 to 45 years with the confirmed diagnosis of pelvic adhesions having indications for surgery (laparoscopic adhesiolysis).

2. Voluntarily and personally signed and dated Form of Informed Consent.

3. Female patients with pelvic adhesions confirmed by gynecological and ultrasound examination.

Exclusion Criteria:

1. Female patients having contraindications to surgical treatment (including acute or exacerbated chronical adnexal inflammation);

2. Body mass index of 30.0 kg/m2 and more;

3. Known hypersensitivity to the test drug components (Seroguard);

4. Pregnancy, breastfeeding or planning a pregnancy during the clinical trial;

5. Refusal to use effective contraception methods throughout the study;

6. Positive HIV, RW, HBV or HCV test result;

7. Alcohol abuse, drug addiction, and toxicomania (except smoking);

8. American Society of Anesthesiologists physical status category III and more (ASA);

9. Purulent process in the abdominal cavity;

10. Disseminated endometriosis;

11. WBC count more than 10*109/L at the complete blood count;

12. Need of using any drugs during the surgery other than 0.02% chlorhexidine aqueous solution throughout the surgery, as well as the test drug or the placebo (0.9% sodium chloride) administered intraperitoneally in the end of surgery.

13. Concomitant diseases that may require conversion of the surgical intervention by other indications;

14. Type I or II diabetes mellitus;

15. Deep vein thrombosis and/or PATE at the screening or in the medical history;

16. Renal impairment (glomerular filtration rate less than 60 mL/min/1.73 m2 assessed by the CKD-EPI equation);

17. Liver disorders defined as more than 2-fold rise of the upper limit of normal of one of the following enzymes: ALT, AST, GGTP, AP, or more than 2-fold total bilirubin increase;

18. Myocardial infarction within 6 months before screening;

19. Any concomitant diseases accompanied by heart failure;

20. Clinically significant ECG changes (as to the investigator's opinion);

21. Any concomitant diseases accompanied by respiratory failure;

22. Any oncological disease within 3 years before enrollment into the study;

23. Systemic inflammatory diseases;

24. Diseases associated with chronic hemorrhages;

25. Blood diseases (anemias of any origin, hemoglobinopathies, inherited and acquired coagulopathies, hemostasis disorders, thrombocytopenias, and thrombocytopathias, any hemoblastoses);

26. Any other disease that, in the investigator's opinion, may affect study results or present an additional threat to well-being of a patient after administration of the study drug;

27. Use of anticoagulants, antiaggregants (except for acetylsalicylic acid at the dose of less than 325 mg/day) at the moment of inclusion into the study or planning to do so during the study;

28. Use of drugs with pronounced hemato-, hepato-, or nephrotoxic action, drugs of biological origin;

29. Need to administer cytostatics, systemic glucocorticosteroids, and other immunosuppressive agents during the patient's participation in the study.

30. Participation in any other clinical trial within 30 days before screening;

31. Contraindications to MRI (presence of implants or implanted electronic devices);

32. Impossibility or inability to comply with the requirements of the protocol, including for physical, psychic or social reasons, in the investigator's opinion.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Krai Government-Owned State Funded Healthcare Institution "Krai Clinical Hospital"	Krasnoyarsk	Krasnoyarsk Krai	Russian Federation	660022
2	State Educational Government-Financed Institution of Higher Professional Education "Krasnoyarsk State Medical University named after Prof. V.F. Voino-Yasenetsky" of the Ministry of Healthcare of the Russian Federation at the clinical site Publicly Funded	Krasnoyarsk	Krasnoyarsk Krai	Russian Federation	660074
3	State Funded Healthcare Institution of Moscow of City Health Department "V.M. Buyanov Municipal Clinical Hospital"	Moscow	Moscow Region	Russian Federation	115516
4	Federal State Institution "V.I. Kulakov Research Center for Obstetrics, Gynecology, and Perinatology" of the Ministry of Healthcare and Social Development of the Russian Federation.	Moscow	Moscow Region	Russian Federation	117997
5	State Educational Government-Financed Institution of Higher Professional Education "Kazan State Medical University" of the Ministry of Health of the Russian at the clinical site of Kazan Maternity Hospital No. 3 named after V.S. Gruzdev	Kazan	Republic Of Tatarstan	Russian Federation	420012
6	State Funded Health Care Institution "Bryansk Municipal Hospital No 1	Bryansk	The Bryansk Region	Russian Federation	241035
7	Federal State Educational Government-Financed Institution of Higher Education "Kemerovo State Medical University" of the Ministry of Healthcare of the Russian Federation at the clinical site of Kemerovo Oblast Publicly Funded Healthcare Institution "L.A.	Kemerovo	The Kemerovo Region	Russian Federation	650000
8	Federal State Funded Healthcare Institution "L.G. Sokolov Federal Biomedical Agency Clinical Hospital No 122".	Saint Petersburg	The Leningrad Region	Russian Federation	194291
9	Federal State Funded Scientific Institution "Research Institute of Obstetrics, Gynecology and Reproductology named after D.O. Ott" of the Ministry of Healthcare of the Russian Federation	Saint Petersburg	The Leningrad Region	Russian Federation	199034
10	Moscow Oblast State Funded Healthcare Institution "Moscow Oblast Research Institute of Obstetrics and Gynecology"	Moscow	The Moscow Region	Russian Federation	101000
11	State Funded Healthcare Institution of Moscow of City Health Department "Moscow Municipal Clinical Hospital No 31"	Moscow	The Moscow Region	Russian Federation	119415
12	State Educational Government-Financed Institution of Higher Professional Education "Rostov State Medical University" of the Ministry of Healthcare of the Russian Federation at the clinical site of Obstetrics and Pediatrics Research Institute	Rostov-on-Don	The Rostov Region	Russian Federation	344013
13	Federal State Educational Government-Financed Institution of Higher Education "I.P. Pavlov Ryazan State Medical University" of the Ministry of Healthcare of the Russian Federation at the clinical site of State Funded Healthcare Institution "Municipal Clin	Ryazan'	The Ryazan Region	Russian Federation
14	Federal State Funded Healthcare Institution "Ural Research Institute of Maternal and Infant Care" of the Ministry of Healthcare of the Russian Federation	Yekaterinburg	The Sverdlovsk Region	Russian Federation	620028

Sponsors and Collaborators

• Pharmasyntez
• Cromos Pharma LLC

Investigators

• Study Chair: Mikhail Shurygin, PhD,D.M.Sc., Pharmasyntez

Study Documents (Full-Text)

• Study Protocol - Mar 6, 2017
• Statistical Analysis Plan - Apr 24, 2017

More Information

Publications

• Ahmad G, Mackie FL, Iles DA, O'Flynn H, Dias S, Metwally M, Watson A. Fluid and pharmacological agents for adhesion prevention after gynaecological surgery. Cochrane Database Syst Rev. 2014 Jul 9;(7):CD001298. doi: 10.1002/14651858.CD001298.pub4. Review. Update in: Cochrane Database Syst Rev. 2020 Jul 17;7:CD001298.
• Al-Jabri S, Tulandi T. Management and prevention of pelvic adhesions. Semin Reprod Med. 2011 Mar;29(2):130-7. doi: 10.1055/s-0031-1272475. Epub 2011 Mar 24. Review.
• Brochhausen C, Schmitt VH, Planck CN, Rajab TK, Hollemann D, Tapprich C, Krämer B, Wallwiener C, Hierlemann H, Zehbe R, Planck H, Kirkpatrick CJ. Current strategies and future perspectives for intraperitoneal adhesion prevention. J Gastrointest Surg. 2012 Jun;16(6):1256-74. doi: 10.1007/s11605-011-1819-9. Review.
• Chow S, Shao J, Wang H. Sample Size Calculations in Clinical Research. 2nd ed.: Chapman&Hall / CRC Biostatistics Series; 2008.
• Coulthard LR, White DE, Jones DL, McDermott MF, Burchill SA. p38(MAPK): stress responses from molecular mechanisms to therapeutics. Trends Mol Med. 2009 Aug;15(8):369-79. doi: 10.1016/j.molmed.2009.06.005. Epub 2009 Aug 6. Review.
• DeCherney AH, Mezer HC. The nature of posttuboplasty pelvic adhesions as determined by early and late laparoscopy. Fertil Steril. 1984 Apr;41(4):643-6.
• Diamond MP, Daniell JF, Feste J, Surrey MW, McLaughlin DS, Friedman S, Vaughn WK, Martin DC. Adhesion reformation and de novo adhesion formation after reproductive pelvic surgery. Fertil Steril. 1987 May;47(5):864-6.
• diZerega GS, Campeau JD. Peritoneal repair and post-surgical adhesion formation. Hum Reprod Update. 2001 Nov-Dec;7(6):547-55. Review.
• diZerega GS. The peritoneum and its response to surgical injury. Prog Clin Biol Res. 1990;358:1-11.
• Dun EC, Nezhat CH. Tubal factor infertility: diagnosis and management in the era of assisted reproductive technology. Obstet Gynecol Clin North Am. 2012 Dec;39(4):551-66. doi: 10.1016/j.ogc.2012.09.006. Review.
• Ghonge NP, Ghonge SD. Computed tomography and magnetic resonance imaging in the evaluation of pelvic peritoneal adhesions: What radiologists need to know? Indian J Radiol Imaging. 2014 Apr;24(2):149-55. doi: 10.4103/0971-3026.134400.
• Gnoth C, Godehardt D, Godehardt E, Frank-Herrmann P, Freundl G. Time to pregnancy: results of the German prospective study and impact on the management of infertility. Hum Reprod. 2003 Sep;18(9):1959-66.
• Gnoth C, Godehardt E, Frank-Herrmann P, Friol K, Tigges J, Freundl G. Definition and prevalence of subfertility and infertility. Hum Reprod. 2005 May;20(5):1144-7. Epub 2005 Mar 31. Review.
• Guerriero S, Ajossa S, Garau N, Alcazar JL, Mais V, Melis GB. Diagnosis of pelvic adhesions in patients with endometrioma: the role of transvaginal ultrasonography. Fertil Steril. 2010 Jul;94(2):742-6. doi: 10.1016/j.fertnstert.2009.03.035. Epub 2009 Apr 14.
• Guerriero S, Ajossa S, Lai MP, Mais V, Paoletti AM, Melis GB. Transvaginal ultrasonography in the diagnosis of pelvic adhesions. Hum Reprod. 1997 Dec;12(12):2649-53.
• Innes A, Burden RP, Finch RG, Morgan AG. Treatment of resistant peritonitis in continuous ambulatory peritoneal dialysis with intraperitoneal urokinase: a double-blind clinical trial. Nephrol Dial Transplant. 1994;9(7):797-9.
• Julious SA. Sample Sizes for Clinical Trials: CRC Press/Taylor & Francis; 2010.
• Katada J, Saito H, Ohashi A. Significance of cyclooxygenase-2 induced via p38 mitogen-activated protein kinase in mechanical stimulus-induced peritoneal adhesion in mice. J Pharmacol Exp Ther. 2005 Apr;313(1):286-92. Epub 2004 Dec 2.
• Kumar B, Koul S, Petersen J, Khandrika L, Hwa JS, Meacham RB, Wilson S, Koul HK. p38 mitogen-activated protein kinase-driven MAPKAPK2 regulates invasion of bladder cancer by modulation of MMP-2 and MMP-9 activity. Cancer Res. 2010 Jan 15;70(2):832-41. doi: 10.1158/0008-5472.CAN-09-2918. Epub 2010 Jan 12.
• Labaille T, Mazoit JX, Paqueron X, Franco D, Benhamou D. The clinical efficacy and pharmacokinetics of intraperitoneal ropivacaine for laparoscopic cholecystectomy. Anesth Analg. 2002 Jan;94(1):100-5, table of contents.
• Lali FV, Hunt AE, Turner SJ, Foxwell BM. The pyridinyl imidazole inhibitor SB203580 blocks phosphoinositide-dependent protein kinase activity, protein kinase B phosphorylation, and retinoblastoma hyperphosphorylation in interleukin-2-stimulated T cells independently of p38 mitogen-activated protein kinase. J Biol Chem. 2000 Mar 10;275(10):7395-402.
• Louizos AA, Hadzilia SJ, Leandros E, Kouroukli IK, Georgiou LG, Bramis JP. Postoperative pain relief after laparoscopic cholecystectomy: a placebo-controlled double-blind randomized trial of preincisional infiltration and intraperitoneal instillation of levobupivacaine 0.25%. Surg Endosc. 2005 Nov;19(11):1503-6. Epub 2005 Oct 3.
• Miller JH, Weinberg RK, Canino NL, Klein NA, Soules MR. The pattern of infertility diagnoses in women of advanced reproductive age. Am J Obstet Gynecol. 1999 Oct;181(4):952-7.
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• Schwartz L, Diamond M. Formation, Reduction, and Treatment of Adhesive Disease. Seminars in Reproductive Medicine. 1991; 9(02): p. 89-99.
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• U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Non-Inferiority Clinical Trials.; 2010 [cited 2015 Dec. Available from: http://www.fda.gov/downloads/Drugs/./Guidances/UCM202140.pdf.
• U.S. Food and Drug Administration. U.S. Food and Drug Administration. [Online]. Northborough; 2006 [cited 2015 Dec 22. Available from: http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4217b1_01_Executive%20Summary.pdf.
• Vaid K, Mehra S, Verma M, Jain S, Sharma A, Bhaskaran S. Pan endoscopic approach "hysterolaparoscopy" as an initial procedure in selected infertile women. J Clin Diagn Res. 2014 Feb;8(2):95-8. doi: 10.7860/JCDR/2014/7271.4018. Epub 2014 Feb 3.
• Ward BC, Kavalukas S, Brugnano J, Barbul A, Panitch A. Peptide inhibitors of MK2 show promise for inhibition of abdominal adhesions. J Surg Res. 2011 Jul;169(1):e27-36. doi: 10.1016/j.jss.2011.01.043. Epub 2011 Feb 23.
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• Responsible Party: Pharmasyntez
• ClinicalTrials.gov Identifier: NCT03660787
• Other Study ID Numbers: SG-2/1215
• First Posted: Sep 7, 2018
• Last Update Posted: Jun 19, 2019
• Last Verified: Jun 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Pharmasyntez: Adhesion; Efficacy
• Additional relevant MeSH terms: Tissue Adhesions

Study Results

Participant Flow

Pre-assignment Detail	114 is the number of enrolled and screened participants according to the protocol, but during the screening process some people were withdrawn from the study before randomization because some of them did not meet the inclusion criteria and some withdrew the informed consent form themselves. So, the number of randomized participants is 104.

Arm/Group Title	Placebo, 1.5 mL/kg	Placebo, 2.4 mL/kg	Seroguard, 1.5 mL/kg	Seroguard, 2.4 mL/kg
Arm/Group Description	each subject received the placebo at the dose of 1.5 mL/kg of body weight; Placebo: Saline	each subject received the placebo at the dose of 2.4 mL/kg of body weight; Placebo: Saline	each subject received the test drug at the dose of 1.5 mL/kg of body weight; Seroguard: Seroguard 0.41 g/L solution	each subject received the test drug at the dose of 2.4 mL/kg of body weight. Seroguard: Seroguard 0.41 g/L solution
Period Title: Overall Study
STARTED	26	26	26	26
COMPLETED	25	25	25	26
NOT COMPLETED	1	1	1	0

Baseline Characteristics

Arm/Group Title	Placebo, 1.5 mL/kg	Placebo, 2.4 mL/kg	Seroguard, 1.5 mL/kg	Seroguard, 2.4 mL/kg	Total
Arm/Group Description	each subject received the placebo at the dose of 1.5 mL/kg of body weight; Placebo: Saline	each subject received the placebo at the dose of 2.4 mL/kg of body weight; Placebo: Saline	each subject received the test drug at the dose of 1.5 mL/kg of body weight; Seroguard: Seroguard 0.41 g/L solution	each subject received the test drug at the dose of 2.4 mL/kg of body weight. Seroguard: Seroguard 0.41 g/L solution	Total of all reporting groups
Overall Participants	26	26	26	26	104
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	26 100%	26 100%	26 100%	26 100%	104 100%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.0 (6.2)	31.6 (5.3)	31.6 (5.4)	31.6 (5.4)	31.5 (5.6)
Sex: Female, Male (Count of Participants)
Female	26 100%	26 100%	26 100%	26 100%	104 100%
Male	0 0%	0 0%	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
Caucasian race	26 100%	26 100%	26 100%	26 100%	104 100%
Region of Enrollment (participants) [Number]
Russia	26 100%	26 100%	26 100%	26 100%	26 25%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Reduction of Adhesions Number by 3 or More
Description	The number of adhesions according to the first MRI data was compared to the number according to the data of second MRI
Time Frame	30±4 days after surgical intervention

Outcome Measure Data

Analysis Population Description

7 patients had no results of repeated Pelvic MRI examination that is why the number of Participants is different

Arm/Group Title	Placebo, 1.5 mL/kg	Placebo, 2.4 mL/kg	Seroguard, 1.5 mL/kg	Seroguard, 2.4 mL/kg
Arm/Group Description	each subject received the placebo at the dose of 1.5 mL/kg of body weight; Placebo: Saline	each subject received the placebo at the dose of 2.4 mL/kg of body weight; Placebo: Saline	each subject received the test drug at the dose of 1.5 mL/kg of body weight; Seroguard: Seroguard 0.41 g/L solution	each subject received the test drug at the dose of 2.4 mL/kg of body weight. Seroguard: Seroguard 0.41 g/L solution
Measure Participants	24	25	23	25
Count of Participants [Participants]	1 3.8%	1 3.8%	10 38.5%	10 38.5%

2. Secondary Outcome

Title	Change in Thickness of Pelvic Adhesions
Description	The change from baseline was defined. It was evaluated by comparing baseline MRI data and repeated MRI data. Results were estimated according to scale from 0 to 3 where 0 - no adhesions, 1 - thin (filmy or filiform), 2 - marked, 3 - marked with an impaired passage through organs involved.
Time Frame	30±4 days after surgery

Outcome Measure Data

Analysis Population Description

7 patients had no results of repeated Pelvic MRI examination that is why the number of Participants is different

Arm/Group Title	Placebo, 1.5 mL/kg	Placebo, 2.4 mL/kg	Seroguard, 1.5 mL/kg	Seroguard, 2.4 mL/kg
Arm/Group Description	each subject received the placebo at the dose of 1.5 mL/kg of body weight; Placebo: Saline	each subject received the placebo at the dose of 2.4 mL/kg of body weight; Placebo: Saline	each subject received the test drug at the dose of 1.5 mL/kg of body weight; Seroguard: Seroguard 0.41 g/L solution	each subject received the test drug at the dose of 2.4 mL/kg of body weight. Seroguard: Seroguard 0.41 g/L solution
Measure Participants	24	25	23	25
Median (Full Range) [score on a scale]	0	0	0	0

3. Secondary Outcome

Title	Number of Participants With Detection of Pelvic Organs Limited Mobility
Description	The frequency was estimated based on transvaginal ultrasound results
Time Frame	30±4 days after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo, 1.5 mL/kg	Placebo, 2.4 mL/kg	Seroguard, 1.5 mL/kg	Seroguard, 2.4 mL/kg
Arm/Group Description	each subject received the placebo at the dose of 1.5 mL/kg of body weight; Placebo: Saline	each subject received the placebo at the dose of 2.4 mL/kg of body weight; Placebo: Saline	each subject received the test drug at the dose of 1.5 mL/kg of body weight; Seroguard: Seroguard 0.41 g/L solution	each subject received the test drug at the dose of 2.4 mL/kg of body weight. Seroguard: Seroguard 0.41 g/L solution
Measure Participants	26	26	26	26
Number [participants]	4 15.4%	4 15.4%	0 0%	2 7.7%

4. Secondary Outcome

Title	Number of Participants With Detection of Hyperechoic Linear Lesions Post Surgery
Description	The frequency was estimated based on transvaginal ultrasound results
Time Frame	30±4 days after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo, 1.5 mL/kg	Placebo, 2.4 mL/kg	Seroguard, 1.5 mL/kg	Seroguard, 2.4 mL/kg
Arm/Group Description	each subject received the placebo at the dose of 1.5 mL/kg of body weight; Placebo: Saline	each subject received the placebo at the dose of 2.4 mL/kg of body weight; Placebo: Saline	each subject received the test drug at the dose of 1.5 mL/kg of body weight; Seroguard: Seroguard 0.41 g/L solution	each subject received the test drug at the dose of 2.4 mL/kg of body weight. Seroguard: Seroguard 0.41 g/L solution
Measure Participants	26	26	26	26
Number [participants]	3 11.5%	2 7.7%	1 3.8%	3 11.5%

5. Secondary Outcome

Title	Change in Number of Participants in Detecting Pelvic Organs Limited Mobility
Description	Absolute change of count of participants was measured with detecting pelvic organs limited mobility from the baseline
Time Frame	30±4 days after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo, 1.5 mL/kg	Placebo, 2.4 mL/kg	Seroguard, 1.5 mL/kg	Seroguard, 2.4 mL/kg
Arm/Group Description	each subject received the placebo at the dose of 1.5 mL/kg of body weight; Placebo: Saline	each subject received the placebo at the dose of 2.4 mL/kg of body weight; Placebo: Saline	each subject received the test drug at the dose of 1.5 mL/kg of body weight; Seroguard: Seroguard 0.41 g/L solution	each subject received the test drug at the dose of 2.4 mL/kg of body weight. Seroguard: Seroguard 0.41 g/L solution
Measure Participants	26	26	26	26
Number [participants]	-17 -65.4%	-17 -65.4%	-21 -80.8%	-21 -80.8%

6. Secondary Outcome

Title	Change Number of Participants in Detecting Hyperechoic Linear Lesions
Description	Frequency of detecting after repeated transvaginal ultrasound results was compared to baseline indications (4 or more)
Time Frame	30±4 days after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo, 1.5 mL/kg	Placebo, 2.4 mL/kg	Seroguard, 1.5 mL/kg	Seroguard, 2.4 mL/kg
Arm/Group Description	each subject received the placebo at the dose of 1.5 mL/kg of body weight; Placebo: Saline	each subject received the placebo at the dose of 2.4 mL/kg of body weight; Placebo: Saline	each subject received the test drug at the dose of 1.5 mL/kg of body weight; Seroguard: Seroguard 0.41 g/L solution	each subject received the test drug at the dose of 2.4 mL/kg of body weight. Seroguard: Seroguard 0.41 g/L solution
Measure Participants	26	26	26	26
Number [participants]	-17 -65.4%	-16 -61.5%	-19 -73.1%	-18 -69.2%

7. Secondary Outcome

Title	Number of Participants With Detection of no Ultrasound Signs of Pelvic Adhesive Disease Post Surgery
Description	No limited mobility of pelvic organs and no hyperechoic linear lesions should be shown
Time Frame	30±4 days after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo, 1.5 mL/kg	Placebo, 2.4 mL/kg	Seroguard, 1.5 mL/kg	Seroguard, 2.4 mL/kg
Arm/Group Description	each subject received the placebo at the dose of 1.5 mL/kg of body weight; Placebo: Saline	each subject received the placebo at the dose of 2.4 mL/kg of body weight; Placebo: Saline	each subject received the test drug at the dose of 1.5 mL/kg of body weight; Seroguard: Seroguard 0.41 g/L solution	each subject received the test drug at the dose of 2.4 mL/kg of body weight. Seroguard: Seroguard 0.41 g/L solution
Measure Participants	26	26	26	26
Count of Participants [Participants]	19 73.1%	19 73.1%	23 88.5%	20 76.9%

Adverse Events

Time Frame	30+-4 days
Arm/Group Title	Placebo, 1.5 mL/kg		Placebo, 2.4 mL/kg		Seroguard, 1.5 mL/kg		Seroguard, 2.4 mL/kg
Arm/Group Description	each subject received the placebo at the dose of 1.5 mL/kg of body weight; Placebo: Saline		each subject received the placebo at the dose of 2.4 mL/kg of body weight; Placebo: Saline		each subject received the test drug at the dose of 1.5 mL/kg of body weight; Seroguard: Seroguard 0.41 g/L solution		each subject received the test drug at the dose of 2.4 mL/kg of body weight. Seroguard: Seroguard 0.41 g/L solution
All Cause Mortality
	Placebo, 1.5 mL/kg		Placebo, 2.4 mL/kg		Seroguard, 1.5 mL/kg		Seroguard, 2.4 mL/kg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)		0/25 (0%)		0/26 (0%)
Serious Adverse Events
	Placebo, 1.5 mL/kg		Placebo, 2.4 mL/kg		Seroguard, 1.5 mL/kg		Seroguard, 2.4 mL/kg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)		0/25 (0%)		0/26 (0%)
Other (Not Including Serious) Adverse Events
	Placebo, 1.5 mL/kg		Placebo, 2.4 mL/kg		Seroguard, 1.5 mL/kg		Seroguard, 2.4 mL/kg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/25 (12%)		2/25 (8%)		1/25 (4%)		0/26 (0%)
Blood and lymphatic system disorders
Anaemia	1/25 (4%)	1	0/25 (0%)	0	0/25 (0%)	0	0/26 (0%)	0
Gastrointestinal disorders
Abdominal pain lower	1/25 (4%)	1	0/25 (0%)	0	0/25 (0%)	0	0/26 (0%)	0
Infections and infestations
Respiratory tract infection viral	0/25 (0%)	0	1/25 (4%)	1	0/25 (0%)	0	0/26 (0%)	0
Reproductive system and breast disorders
Dysmenorrhoea	0/25 (0%)	0	1/25 (4%)	1	0/25 (0%)	0	0/26 (0%)	0
Polymenorrhoea	1/25 (4%)	1	0/25 (0%)	0	0/25 (0%)	0	0/26 (0%)	0
Skin and subcutaneous tissue disorders
Pruritus	0/25 (0%)	0	0/25 (0%)	0	1/25 (4%)	1	0/26 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.