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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04109404
Other study ID # 29BRC19.0030
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 25, 2019
Est. completion date June 1, 2019

Study information

Verified date September 2019
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Investigators observe an increase risk of meningioma in patient treated by CYPROTERONE ACETATE or other form of progestin. Investigatorsdiscribe caractéristics of meningioma and treatement of the patients follow up in CHRU of Brest


Description:

Retrospective study in CHRU of brest, the investigators selected patient with history of méningioma and treated by CYPROTERONE ACETATE, CHLORMADINONE ACETATE and NOMEGESTROL ACETATE essentially The investigators excluded patient with risk factor of meningioma added at hormonal treatment exposition The investigators discribe the caractéristique of patients: age, sex, duration of the treatment, the caractéristique of the meningioma: localization, grade, hormonal receptors, treatment by surgery or radiotherapy and changing after discontinuation of treatment


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date June 1, 2019
Est. primary completion date June 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- minimum 18 years

- medical follow up in CHRU of Brest

- treated by CYPROTERONE ACETATE and/or CHLORMADINONE ACETATE NOMEGESTROL ACETATE, PROGESTERONE , DYDROGESTERONE PROMEGESTONE , NORETHISTERONE, LEVONORGESTREL , oestroprogestogenic contraception

- meningioma after treatement by progestin or CYPROTERONE ACETATE

Exclusion Criteria:

- history ofbreast cancer

- history of cerebral radiotherapy

- history of neurofibromatosis

- meningioma before treatement by progestin or CYPROTERONE ACETATE

- minor patient

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Département de Nutrition - CHRU de Brest Brest

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

References & Publications (2)

Bernat AL, Oyama K, Hamdi S, Mandonnet E, Vexiau D, Pocard M, George B, Froelich S. Growth stabilization and regression of meningiomas after discontinuation of cyproterone acetate: a case series of 12 patients. Acta Neurochir (Wien). 2015 Oct;157(10):1741-6. doi: 10.1007/s00701-015-2532-3. Epub 2015 Aug 12. — View Citation

S. Froelich, "Does cyproterone acetate promote multiple meningiomas?," 2009.

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnosis of meningiomas caracteristics meningiomas caracteristics in patient treated with CYPROTERONE ACETATE or Progestin description 12 months
Secondary prescription status of progestogenic treatment indications, duration of treatment, name and type of treatment 12 months
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