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MERCURE study: MEthotrexate in ReCurrent dVIN
EU CTIS ID: 2025-524373-17-00
What this study is testing
Determine the effectiveness of MTX in prevention of recurrence in dVIN by the time-to recurrence before and after the use of MTX in women with therapy resistant lichen sclerosus and recurrent dVIN lesions.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age of 18 years or older.
- Failure to standard therapy with intensive clobetasol ointment either or not combined with tacrolimus 0,1% ointment. Failure to standard therapy is defined by complaints of lichen sclerosus which are insufficiently controlled by the topical therapy.
- Recurrent dVIN lesions, at least 1 previous dVIN, for which surgical treatment has been performed.
You likely can't join if
- Concomitant diagnoses of vulvar cancer
- Insufficient knowledge of the Dutch or English language
- Alcohol abuse.
- Oral or gastro-intestinal ulcera or stomatitis
- Recently received a live attenuated vaccine or when in need of receiving a live attenuated vaccine.
- Severe decreased liver function with a serum bilirubin value >85,5umol/l or >5mg/dl
See the full eligibility criteria
- Age of 18 years or older.
- Failure to standard therapy with intensive clobetasol ointment either or not combined with tacrolimus 0,1% ointment. Failure to standard therapy is defined by complaints of lichen sclerosus which are insufficiently controlled by the topical therapy.
- Recurrent dVIN lesions, at least 1 previous dVIN, for which surgical treatment has been performed.
- Concomitant diagnoses of vulvar cancer
- Insufficient knowledge of the Dutch or English language
- Alcohol abuse.
- Oral or gastro-intestinal ulcera or stomatitis
- Recently received a live attenuated vaccine or when in need of receiving a live attenuated vaccine.
- Severe decreased liver function with a serum bilirubin value >85,5umol/l or >5mg/dl
- Severe decreased kidney function with creatinine clearance of <30ml/min
- Bone marrow diseases (including leukopenia, thrombocytopenia, anemia, bone marrow hypoplasia)
- Acute or chronic infections (including HIV/AIDS, tuberculosis)
- Immunodeficiency or immunosuppressive medication
- Severe pulmonary disease
- Pregnancy or current pregnancy wish
- Legal incapability
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.