Use of Recombinant hCG to Prevent Breast Cancer in BRCA1 and BRCA2 Carriers

Plain-language summary

This study evaluates the use of the drug Ovitrelle, a recombinant hCG, to help prevent breast cancer in women who carry BRCA1 and BRCA2 gene changes. It enrolled premenopausal women who were BRCA1 carriers. The study was conducted in Phase 4 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 4

Status

Completed

Sponsor

University Hospital, Ghent

Intervention

Ovitrelle

Start date

2/17/2016

Estimated completion

12/18/2018

Countries

Belgium

Related genes

Locations

• Ghent, Belgium

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* premenopausal women
* BRCA1 carrier

Exclusion Criteria:

* History of allergic reaction to compounds of similar chemical or biologic composition to hCG
* receiving medication that could interfere with the study protocol objectives (hormonal contraceptives, androgens, prednisone, thyroid hormones, insulin)
* previous treatment with follicle stimulating hormone for assisted reproduction
* uncontrolled intercurrent illness
* Heart disease
* Severe cognitive decline
* Psychiatric desease
* HIV positive
* Hepatitis B or C infection