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'Medroxyprogesterone acetate (MPA) in Familial Adenomatous Polyposis, a proof of principle study’

'Medroxyprogesterone acetate (MPA) in Familial Adenomatous Polyposis, a proof of principle study’

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25407
Enrollment
10
Registered
2008-08-04
Start date
2008-08-04
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Familial adenomatous polyposis

Interventions

2x colonoscopy with biopsies taken. Treatment with MPA 10 mg/day for 4 months

Sponsors

afdeling maag darm en leverziekten LUMC
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Females > 14 years of age 2. Established FAP, confirmed by prior colonoscopy 3. Patients must be able to adhere to the study visits and protocol requirements 4. 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: 1. Females before menarche 2. Prior progestin use in the past year 3. Change in the use of NSAIDs at least 3 month prior to the study 4. Allergic reaction on MPA during previous use 5. Female patients who are pregnant or breast-feeding. 6. Prior thromboflebitis or thromboembolism. 7. 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. 8. Patients with fertility wish for the study period 9. Not available for follow-up assessment

Design outcomes

Primary

MeasureTime frame
Change in polyp burden

Secondary

MeasureTime frame
Biological response in the target tissue (colon)

Contacts

Public ContactJarom Heijmans

Leiden University Medical Center (LUMC) Department of Gastroenterology and Hepatology

j.heijmans@lumc.nl+31 (0)71 5262272

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)