Female Genital SchistosomiasisPhase 3WINGS-4-FGSNCT07915518
A Phase III Trial to Evaluate the Safety and Efficacy of Anti-inflammatory Drugs in Addition to Praziquantel in Girls and Women With Female Genital Schistosomiasis
A Phase 3 study testing Praziquantel 80, Prednisolone and Diclofenac in people with Female Genital Schistosomiasis, run by Brian Ngwira at 4 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- Conditions the study is for
- Female Genital Schistosomiasis
- What is being tested?
- Praziquantel 80, Prednisolone and Diclofenac
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 1 Jan 2027to Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Signed written Informed Consent by Participant and assent for minor participants.
- Girls and women aged 15- 49 years.
- Weight ≥ 35kgs (only in the applicable countries due to Diclofenac prescription limitation)
- Girls and women must have had their sexual debut.
- Agreed to have a gynecological exam including colposcopy, provide a cervicovaginal swab and lavage, urine, stool, and a venous sample.
- Confirmed case of FGS: (a) self-reporting symptoms AND (b) parasitological/antigen confirmation of Schistosoma infection (Egg positivity) AND (c) DNA positivity from genital samples AND (d) FGS pathognomonic lesions from colposcopy.
- Acceptance of the requirement to use a barrier form of birth control (e.g. condoms) or other effective contraceptive method effective from Day 1 until Day 57 or documented permanent infertility or postmenopausal status.
Who cannot join
- Pregnant women.
- Gynecological or any other type of cancer.
- Presence of abnormal physical findings or laboratory values at screening (e.g. severe anaemia) that could interfere with the objectives of the trial or the safety of the subject, in the opinion of the Investigator.
- Any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the participant (example, compromise the well-being of the participant), or that could prevent, limit, or confound the protocol specified assessments.
- Treatment with PZQ or drugs with known anti-schistosomal effect within the last 3 months.
- History or presence of gastro-duodenal ulcers or hematemesis, signs, or symptoms of gastritis.
Show all 10Show fewer
- Contraindication to any of the study drugs, as stated in the approved Reference Safety Information (SmPC).
- Living less than one year in the community.
- Known allergy to the drugs or any of their ingredients used in the trial.
- Current enrolment or past participation in another investigational trial in which an investigational intervention (e.g. drug, vaccine, invasive devise) was administered within 30 days or 5 half-lives (whichever is the longest) before first dose of trial drug (to be adjusted as per country-specific regulation).
Trial locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 4 countries
Côte d’Ivoire1 site
Bouafle and Zuenoula
Abidjan
Mamadou Doctor, +265884595095, mamadou_ouatt@yahoo.fr
Democratic Republic of the Congo1 site
Kimpese
Kimpese
Dieudonne Professor, +265884595095, mumbadiedonne@yahoo.fr
Malawi1 site
Mangochi DHO
Mangochi
Jenalisa Professor, +265884595095, jmusaya@mlw.mw
About this study
Official title: A Phase III, Randomised, Open-Label, Parallel-Group, Controlled Trial to Evaluate the Safety and Efficacy of Anti-inflammatory Drugs (Diclofenac and Prednisolone) in Addition to Praziquantel in Girls and Women (15-49 Years Old) With Female Genital Schistosomiasis
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).
- Conditions
- Female Genital Schistosomiasis
- Being tested
- Praziquantel 80, Prednisolone, Diclofenac, Diclofenac given with Praziquantel 80mg (High dose), Prednisolone given with Praziquantel 80mg (High dose)
- Keywords
- WINGS-4-FGS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Praziquantel 80Drug
Praziquantel 80mg (High dose) compared to 40mg SoC
PrednisoloneDrug
5 days Prednisolone 20mg given with Praziquantel 40mg
DiclofenacDrug
5 days Diclofenac given with Praziquantel 40mg
DiclofenacDrug
15 days Diclofenac given with Praziquantel 40mg
Diclofenac given with Praziquantel 80mg (High dose)Drug
Diclofenac 75mg from day 1 to day 5 given with Praziquantel 80mg/kg dose on days 1, 28 and 56.
Prednisolone given with Praziquantel 80mg (High dose)Drug
Prednisolone 20mg from day 1 to day 5 given with Praziquantel 80mg/kg dose on days 1, 28 and 56.
15d Diclofenac given with Praziquantel 80mg (High dose)Drug
Diclofenac 75mg from day 1 to day 15 given with Praziquantel 80mg/kg dose on days 1, 28 and 56.
| Study group | Role | What they receive |
|---|---|---|
| Praziquantel 40 | No intervention | Praziquantel 40 given on day 1, day 28 and day 56 |
| Praziquantel 80 | Experimental | Praziquantel 80 given on day 1, day 28 and day 56 Receives: Drug: Praziquantel 80 |
| Praziquantel 40 plus Prednisolone 5d | Experimental | Praziquantel 40 given on day 1, day 28 and day 56 plus Prednisolone from day 1 to day 5 Receives: Drug: Prednisolone |
| Praziquantel 80 plus Prednisolone 5d | Experimental | Praziquantel 80 given on day 1, day 28 and day 56 plus Prednisolone from day 1 to day 5 Receives: Drug: Prednisolone given with Praziquantel 80mg (High dose) |
| Praziquantel 40 plus Diclofenac 5d | Experimental | Praziquantel 40 given on day 1, day 28 and day 56 plus Diclofenac from day 1 to day 5 Receives: Drug: Diclofenac |
| Praziquantel 80 plus Diclofenac 5d | Experimental | Praziquantel 80 given on day 1, day 28 and day 56 plus Diclofenac from day 1 to day 5 Receives: Drug: Diclofenac given with Praziquantel 80mg (High dose) |
| Praziquantel 40 plus Diclofenac 15d | Experimental | Praziquantel 40 given on day 1, day 28 and day 56 plus Diclofenac from day 1 to day 15 Receives: Drug: Diclofenac |
| Praziquantel 80 plus Diclofenac 15d | Experimental | Praziquantel 80 given on day 1, day 28 and day 56 plus Diclofenac from day 1 to day 15 Receives: Drug: 15d Diclofenac given with Praziquantel 80mg (High dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Jan 2027 (estimated)
- Primary completion30 Jan 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Genital SchistosomiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 4x2 FACTORIAL RANDOMISED CONTROLLED TRIAL
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brian Ngwira
- Sponsor type
- University, hospital or other
- Collaborators
- Kamuzu University of Health Sciences, Institut National de Recherche Biomedicale (INRB), Université Félix Houphouët-Boigny, University of Health and Allied Sciences
- Responsible party
- Sponsor-investigator, Brian Ngwira, Malawi Liverpool Wellcome Programme
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915518
- Sponsor's protocol ID
- FGS-DPP-01
- Other IDs
- 101190584
- Acronym
- WINGS-4-FGS
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomised, Open-Label, Parallel-Group, Controlled Trial to Evaluate the Safety and Efficacy of Anti-inflammatory Drugs (Diclofenac and Prednisolone) in Addition to Praziquantel in Girls and Women (15-49 Years Old) With Female Genital Schistosomiasis
- ClinicalTrials.gov ID
- NCT07915518
- Acronym / sponsor ID
- WINGS-4-FGS / FGS-DPP-01
- Conditions
- Female Genital Schistosomiasis
- Keywords
- WINGS-4-FGS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Brian NgwiraUniversity, hospital or other
- Collaborators
- Kamuzu University of Health Sciences, Institut National de Recherche Biomedicale (INRB), Université Félix Houphouët-Boigny, University of Health and Allied Sciences
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 30 Jan 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- 4x2 FACTORIAL RANDOMISED CONTROLLED TRIAL
| Arm | Type | Receives |
|---|---|---|
| Praziquantel 40 | No intervention | –Praziquantel 40 given on day 1, day 28 and day 56 |
| Praziquantel 80 | Experimental | Drug: Praziquantel 80Praziquantel 80 given on day 1, day 28 and day 56 |
| Praziquantel 40 plus Prednisolone 5d | Experimental | Drug: PrednisolonePraziquantel 40 given on day 1, day 28 and day 56 plus Prednisolone from day 1 to day 5 |
| Praziquantel 80 plus Prednisolone 5d | Experimental | Drug: Prednisolone given with Praziquantel 80mg (High dose)Praziquantel 80 given on day 1, day 28 and day 56 plus Prednisolone from day 1 to day 5 |
| Praziquantel 40 plus Diclofenac 5d | Experimental | Drug: DiclofenacPraziquantel 40 given on day 1, day 28 and day 56 plus Diclofenac from day 1 to day 5 |
| Praziquantel 80 plus Diclofenac 5d | Experimental | Drug: Diclofenac given with Praziquantel 80mg (High dose)Praziquantel 80 given on day 1, day 28 and day 56 plus Diclofenac from day 1 to day 5 |
| Praziquantel 40 plus Diclofenac 15d | Experimental | Drug: DiclofenacPraziquantel 40 given on day 1, day 28 and day 56 plus Diclofenac from day 1 to day 15 |
| Praziquantel 80 plus Diclofenac 15d | Experimental | Drug: 15d Diclofenac given with Praziquantel 80mg (High dose)Praziquantel 80 given on day 1, day 28 and day 56 plus Diclofenac from day 1 to day 15 |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Signed written Informed Consent by Participant and assent for minor participants.
- Girls and women aged 15- 49 years.
- Weight ≥ 35kgs (only in the applicable countries due to Diclofenac prescription limitation)
- Girls and women must have had their sexual debut.
- Agreed to have a gynecological exam including colposcopy, provide a cervicovaginal swab and lavage, urine, stool, and a venous sample.
Key exclusion criteria (10 listed)
- Pregnant women.
- Gynecological or any other type of cancer.
- Presence of abnormal physical findings or laboratory values at screening (e.g. severe anaemia) that could interfere with the objectives of the trial or the safety of the subject, in the opinion of the Investigator.
- Any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the participant (example, compromise the well-being of the participant), or that could prevent, limit, or confound the protocol specified assessments.
- Treatment with PZQ or drugs with known anti-schistosomal effect within the last 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Praziquantel 80Praziquantel 80mg (High dose) compared to 40mg SoC | Drug | Praziquantel 80 |
| Prednisolone5 days Prednisolone 20mg given with Praziquantel 40mg | Drug | Praziquantel 40 plus Prednisolone 5d |
| Diclofenac5 days Diclofenac given with Praziquantel 40mg | Drug | Praziquantel 40 plus Diclofenac 5d |
| Diclofenac15 days Diclofenac given with Praziquantel 40mg | Drug | Praziquantel 40 plus Diclofenac 15d |
| Diclofenac given with Praziquantel 80mg (High dose)Diclofenac 75mg from day 1 to day 5 given with Praziquantel 80mg/kg dose on days 1, 28 and 56. | Drug | Praziquantel 80 plus Diclofenac 5d |
| Prednisolone given with Praziquantel 80mg (High dose)Prednisolone 20mg from day 1 to day 5 given with Praziquantel 80mg/kg dose on days 1, 28 and 56. | Drug | Praziquantel 80 plus Prednisolone 5d |
| 15d Diclofenac given with Praziquantel 80mg (High dose)Diclofenac 75mg from day 1 to day 15 given with Praziquantel 80mg/kg dose on days 1, 28 and 56. | Drug | Praziquantel 80 plus Diclofenac 15d |
Primary outcome
Improvement in pathognomonic sign(s) in the cervix from baseline to month 3.
Time frame: 3 months
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.
Improvement (reduction) in urogenital frequency symptom score from baseline to month 3.
Time frame: 3 months
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.
3 secondary outcomes
Effect of anti-inflammatory and Praziquantel dose on overall clinical improvement in women with FGS
Time frame: 12 months
Effect of anti-inflammatory and Praziquantel dose on parasitological improvement in women with Female Genital Schistosomiasis.
Time frame: 12 months
Safety and tolerability of anti-inflammatory and Praziquantel treatment in women with Female Genital Schistosomiasis
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Female Genital Schistosomiasis
Recruiting
MATCHING - feMAle geniTal sCHistosomiasis IN miGrants Female Genital Schistosomiasis in Migrants Presenting to an Outpatient Clinic in Italy: Prevalence and Clinical Impact
Female Genital Schistosomiasis
Not yet recruiting
Female Genital Schistosomiasis in Migrant Women: A Pilot Study
Diagnostic, Schistosomiasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Praziquantel 80, Prednisolone and Diclofenac in people with Female Genital Schistosomiasis, run by Brian Ngwira at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Côte d’Ivoire, Democratic Republic of the Congo, Ghana, Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janelisa Professor (+265884595095, jmusaya@mlw.mw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in pathognomonic sign(s) in the cervix from baseline to month 3. (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.