HIRISE (High-Risk women and hormonal Substitution Exposure).
Recruiting
- Conditions
- Women with an increased risk for breast- and ovarian cancer due to a genetic prediposition, after prophylactic adnectomy.
- Registration Number
- NL-OMON20562
- Lead Sponsor
- Initiator : Anca C. Ansink, MD, PHD, gynaecological oncologistDept. Obstetrics & Gynaecology, room A1-40Erasmus MC- Daniel den Hoed Oncology CenterPO BOX 52013008 AE RotterdamThe Netherlandsphone: +31 10 4391263fax +31 10 4391011E-mail: a.ansink@erasmusmc.nlsecundary sponsor:NV Organon Molenstraat 110Postbus 205340BH OssThe Netherlandsphone+ 31 412661222fax. +31 412662617
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 177
Inclusion Criteria
1. Prophylactic adnectomy not longer than five years ago, or scheduled to undergo prophylactic adnectomy within the next six months from randomization;
2. Age 25-50 years;
Exclusion Criteria
1. HST/ OAC (oral anticonceptive) intake in the last three months;
2. History of breast cancer. Patients who have had adequately treated skin cancer (non-melanoma) or cervical carcinoma in situ are eligible. Furthermore, patients who have had another malignancy in the past, but have been disease free for more than 5 years are also eligible;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Change in mammographic breast density;<br /><br>2. Menopausal symptoms and sexuality.
- Secondary Outcome Measures
Name Time Method 1. Generic quality of life;<br /><br>2. Compliance;<br /><br>3. Bone density;<br /><br>4. Incidence of benign breast disorders;<br /><br>5. Incidence of breast carcinoma (in situ and invasive);<br /><br>6. Incidence of other malignancies;<br /><br>7. Incidence of gynecological disorders;<br /><br>8. Incidence of cardiovascular disease;<br /><br>9. Incidence of biliary surgery;<br /><br>10. Incidence of bone fractures;<br /><br>11. LDL and HDL levels;<br /><br>12. Androgen levels.