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Clinical Trials/NCT01810900
NCT01810900
Terminated
Phase 3

To Assess the Anti-adhesive Effect and Safety of Protescal Following Laparoscopic Surgery

LG Life Sciences1 site50 target enrollmentSeptember 2012
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ConditionsLaparoscopic Myomectomy

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Laparoscopic Myomectomy
Sponsor
LG Life Sciences
Enrollment
50
Locations
1
Primary Endpoint
presence/absence of postoperative adhesions at second-look procedure
Status
Terminated
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This multicenter, randomized, single-blind study assessed the safety and efficacy of Protescal for the reduction of post-operative adhesion formation following myomectomy.

Detailed Description

The age of the patients participating in the study overed 20 years and included nonpregnant women requiring laparoscopic myomectomy and expected to undergo a second-look laparoscopy as part of their treatment plan 5 weeks after the initial surgery.

Registry
clinicaltrials.gov
Start Date
September 2012
End Date
December 2013
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
LG Life Sciences
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •a woman who is over 20 years old
  • •a woman who needs a laparoscopic myomectomy

Exclusion Criteria

  • •a pregnant woman and a nursing mother

Outcomes

Primary Outcomes

presence/absence of postoperative adhesions at second-look procedure

Time Frame: at second look laparoscopy after 5 weeks later initial laparoscopic myomectomy

Study Sites (1)

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