Efficacy and Dose Ranging Study of Seroguard (NCT03660787) | Clinical Trial Compass
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 range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Reduction of Adhesions Number by 3 or More