medroxyprogesterone acetate (MPA) in Familial Adenomatous Polyposis, a proof of principle study
- Conditions
- familial adenomatous polyposis (FAP)familial polyposis1008362410017990
- Registration Number
- NL-OMON31609
- Lead Sponsor
- maag darm leverziekten
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 10
• 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
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Change in adenoma number or density.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Changes in biological and histological parameters.</p><br>