Treatment of Female Genital Schistosomiasis (FGS) With Praziquantel: A Proof-of-Concept Study (NCT04115072) | Clinical Trial Compass
CompletedPhase 2/3
Treatment of Female Genital Schistosomiasis (FGS) With Praziquantel: A Proof-of-Concept Study
Madagascar116 participantsStarted 2019-09-03
Plain-language summary
Female genital schistosomiasis (FGS) is a frequent manifestation of the infection with Schistosoma haematobium or mansoni. FGS is probably the most neglected gynaecological condition in the tropics.
Inflammation of genital tissue persists as long as adult worms are present in the circulation, and new eggs are released. Hence, lesions can only heal if the inflammation is abated and a normal immune response is restored
A randomized controlled study will be carried out to compare the efficacy of the standard treatment with that of five repeated doses of praziquantel.
Outcome measure is the disappearance/regression of clinical pathology at the cervix, in the vagina/vulva.
Who can participate
Age range
15 Years – 35 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:
* Women 15 to 35 years of age with a gynaecological/urinary/lower abdominal complaint
* The woman has signed the informed consent form (IFC); in the case of minors, the IFC has to be signed by parent or guardian.
* The woman does not plan to leave the area within 6 months and accept to come to the CSB regularly following the scheduled follow-up (at week 5,10 and 15).
* The woman with confirmed diagnosed of FGS (as described in section 6.3.1)
* The woman agrees to be examined clinically and gynaecologically including taking specimens from the genital tract (collection of vaginal lavage fluid, collection of cells with a cytobrush).
* The woman agrees to provide a urine and a stool sample.
* The woman agrees that a venous blood sample for laboratory assessments is taken.
* The woman accepts to stay at the hospital for 2 days follow-up after the first dose of PZQ.
Exclusion Criteria:
* Virgin (assessed by gynaecologist)
* Pregnancy (determined by pregnancy test)
* Tumor of vulva, vagina, uterus (diagnosed by gynaecologist)
* Treatment with praziquantel during the last 3 months
* Hysterectomy
* Known HIV positive prior to enrollment
* Any severe medical condition requiring hospitalization
* The woman is unable to comprehend the nature and objectives of the study
* The woman is judged by the investigators to be unlikely to participate regularly in the follow-up
* The woman is taking any drug that might affect the metabolism of PZQ and that is contraindicated …
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.