A Phase 3 interventional study of Praziquantel 80 and Prednisolone in Female Genital Schistosomiasis, sponsored by Brian Ngwira. Not yet recruiting at 4 sites in 4 countries. Open to female participants aged 15 Years to 49 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Brian Ngwira · Phase 3, Interventional, and Treatment
Female Genital Schistosomiasis (FGS) is a neglected complication of Schistosoma haematobium infection affecting an estimated 56 million women and girls globally, with a high burden in sub-Saharan Africa. Up to 75% of infected women develop genital lesions, often without being aware of their condition. FGS causes chronic genital and urinary symptoms, overlaps clinically with sexually transmitted infections, and increases the risk of HIV acquisition by 2-4 times. FGS remains widely underdiagnosed due to limited healthcare provider training, stigma, and lack of affordable diagnostic tools in resource-limited settings. Current control strategies rely on mass drug administration of praziquantel (PZQ) targeting school-aged children and adults in high risk or endemic communities, which neither adequately reaches affected women nor addresses established genital morbidity. PZQ eliminates adult worms but does not reverse chronic inflammation or granulomas caused by trapped eggs, and no clinical guidelines exist for managing FGS-related morbidity. Given these gaps, there is an urgent need to evaluate additional, locally available treatments in combination with praziquantel to reduce inflammation, improve morbidity outcomes, and inform effective clinical management of FGS.
This trial is funded by Global Health EDCTP3 and sponsored by KUHeS, INRB, UFHB, and UHAS. This Phase III, open label, 4x2 factorial superiority randomized controlled trial will take place in multiple schistosomiasis endemic countries in sub-Saharan Africa, among women living with schistosomiasis, testing already registered anti-inflammatory drugs (prednisolone, diclofenac). Each arm shall have at least 100 participants, who shall be followed up at 3-, 6-, and 12-month post first IP administration.
The trial will recruit 800 girls and women of reproductive age (15- 49 years) at 4 sites (Malawi, Ghana, Democratic Republic of Congo, and Cote d'Ivoire), with each site aiming to recruit 200 participants (25 per site per treatment arm).
79 studies on the registry are indexed under Schistosomiasis; 14 are open to participants now.
This study's planned enrollment of 800 is above the median of 289 across 52 interventional studies indexed under Schistosomiasis.
Browse Schistosomiasis studies →This is the only study on the registry with Brian Ngwira as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Praziquantel 40 given on day 1, day 28 and day 56
Praziquantel 80 given on day 1, day 28 and day 56
Drug: Praziquantel 80
Praziquantel 40 given on day 1, day 28 and day 56 plus Prednisolone from day 1 to day 5
Drug: Prednisolone
Praziquantel 80 given on day 1, day 28 and day 56 plus Prednisolone from day 1 to day 5
Drug: Prednisolone given with Praziquantel 80mg (High dose)
Praziquantel 40 given on day 1, day 28 and day 56 plus Diclofenac from day 1 to day 5
Drug: Diclofenac
Praziquantel 80 given on day 1, day 28 and day 56 plus Diclofenac from day 1 to day 5
Drug: Diclofenac given with Praziquantel 80mg (High dose)
Praziquantel 40 given on day 1, day 28 and day 56 plus Diclofenac from day 1 to day 15
Drug: Diclofenac
Praziquantel 80 given on day 1, day 28 and day 56 plus Diclofenac from day 1 to day 15
Drug: 15d Diclofenac given with Praziquantel 80mg (High dose)
Praziquantel 80mg (High dose) compared to 40mg SoC
5 days Prednisolone 20mg given with Praziquantel 40mg
5 days Diclofenac given with Praziquantel 40mg
15 days Diclofenac given with Praziquantel 40mg
Diclofenac 75mg from day 1 to day 5 given with Praziquantel 80mg/kg dose on days 1, 28 and 56.
Prednisolone 20mg from day 1 to day 5 given with Praziquantel 80mg/kg dose on days 1, 28 and 56.
Diclofenac 75mg from day 1 to day 15 given with Praziquantel 80mg/kg dose on days 1, 28 and 56.
Improvement in pathognomonic sign(s) in the cervix from baseline to month 3.
Improvement in pathognomonic sign(s) in the cervix from baseline to month 3 (binary outcome of improvement vs no improvement) from cervical assessments only using Female Genital Schistosomiasis lesion indicators; grainy sandy patches, homogenous yellow patches and rubbery papules.
Time frame: 3 months
Improvement (reduction) in urogenital frequency symptom score from baseline to month 3.
Improvement (reduction) in urogenital (gynaecological) frequency symptom score on a 0-4 scale, calculated as sum total of eight symptom components; lower abdominal pain, dysuria, vulvovaginal itching, abnormal vaginal discharge, menstrual disturbances, intermenstrual bleeding, dyspareunia and bleeding during or after intercourse, from baseline to month 3 (continuous outcome). Higher scores will indicate greater symptom burden.
Time frame: 3 months
Effect of anti-inflammatory and Praziquantel dose on overall clinical improvement in women with FGS
Assessing improvement in pathognomonic sign(s) in the cervix by FGS lesion indicators and urogenital (gynaecological) overall symptom score from baseline to months 3 (PZQ dose comparison only), 6 and 12.
Time frame: 12 months
Effect of anti-inflammatory and Praziquantel dose on parasitological improvement in women with Female Genital Schistosomiasis.
Assessed by measuring; Antigen (Circulating Anodic Antigen) concentration in urine at day 28, day 56 and month 3, 6, 12, total egg count by urine filtration at days 28 and 56 and months 3, 6, 12, and the absence of schistosome DNA in cervicovaginal swabs at months 3, 6, 12.
Time frame: 12 months
Safety and tolerability of anti-inflammatory and Praziquantel treatment in women with Female Genital Schistosomiasis
Assessing the safety and tolerability of trial treatments by occurrence of treatment emergent adverse events (TEAE) in all arms categorized as; non-serious TEAEs up to day 57, serious adverse events (SAEs) up to day 57, TEAE leading to discontinuation of treatment up to day 57, TEAE leading to trial withdrawal up to day 57, Fatal SAE up to month 12, and TEAE reported as related to trial drugs up to month 12.
Time frame: 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Jan 2028, 12 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Prednisolone · Diclofenac