familial adenomatous polyposis (FAP) familial polyposis
Conditions
Interventions
All patients receive MPA (Provera, Pfizer BV) in a daily dosage of 10 mg for
four months.
Sponsors
maag darm leverziekten
Eligibility
Age
12 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Females > 14 years of age • Established FAP, confirmed by prior colonoscopy • Patients must be able to adhere to the study visits and protocol requirements • Patients must be able to give written informed consent. In case of a minor, parents/legal representative must be able to give a written consent. The consent must be obtained prior to any screening procedures
Exclusion criteria
Exclusion criteria: • Prior progestin use in the past year • Change in the use of NSAIDs at least 3 month prior to the study • Allergic reaction on MPA during previous use • Female patients who are pregnant or breast-feeding. • Prior thromboflebitis or thromboembolism. • Previous or current serious cardiac or cerebrovascular condition. Like thromboflebitis or thromboembolism, severe hypertension, severe liverfunction disorders. A history of jaundice, herpes gestationis non-explained vaginal bleeding or deterioration of otosclerosis during pregnancy or use of female hormones. • Male and female patients with fertility wish for the study period • Not available for follow-up assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in adenoma number or density. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in biological and histological parameters. | — |
Countries
Netherlands
Outcome results
None listed