CompletedPhase 2

Efficacy and Dose Ranging Study of Seroguard

Russia114 participantsStarted 2017-05-04

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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Inclusion criteria

✓. Female patients aged from 18 to 45 years with the confirmed diagnosis of pelvic adhesions having indications for surgery (laparoscopic adhesiolysis).
✓. Voluntarily and personally signed and dated Form of Informed Consent.
✓. Female patients with pelvic adhesions confirmed by gynecological and ultrasound examination.

Exclusion criteria

✕. Female patients having contraindications to surgical treatment (including acute or exacerbated chronical adnexal inflammation);
✕. Body mass index of 30.0 kg/m2 and more;
✕. Known hypersensitivity to the test drug components (Seroguard);
✕. Pregnancy, breastfeeding or planning a pregnancy during the clinical trial;
✕. Refusal to use effective contraception methods throughout the study;
✕. Positive HIV, RW, HBV or HCV test result;
✕. Alcohol abuse, drug addiction, and toxicomania (except smoking);
✕. American Society of Anesthesiologists physical status category III and more (ASA);

What they're measuring

Number of Participants With Reduction of Adhesions Number by 3 or More

Timeframe: 30±4 days after surgical intervention

Trial details

NCT IDNCT03660787

SponsorPharmasyntez

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-01-23

Results submitted2018-10-31

View on ClinicalTrials.gov More Adhesion trials