Treatment of Female Genital Schistosomiasis (FGS) With Praziquantel: A Proof-of-Concept Study
Status:
Completed
Trial end date:
2020-02-21
Target enrollment:
Participant gender:
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Vendsyssel Hospital
Collaborators:
Charite University, Berlin, Germany Leiden University Medical Center Merck Serono International SA Ministry of Health, Madagascar Nagasaki University Umeå University