Clinical trial · Observational
Health After eaRly Menopause Due to Oophorectomy
Favourable and Unfavourable Health Effects of Risk-Reducing Salpingo-Oophorectomy in Women With a High Genetic Risk of Ovarian Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Risk-Reducing Salpingo-Oophorectomy (RRSO) at the age of 35 to 45 years is recommended for women with a high genetic risk for ovarian cancer. While this procedure decreases the risk of ovarian cancer by 80-96%, it also results in an immediate menopause. Current research on potential adverse effects of premenopausal risk-reducing salpingo-oophorectomy, such as increased risk of cardiovascular disease, compromised bone health, cognitive dysfunction and reduced quality of life, is limited, mostly due to short follow up. The investigators will conduct a multicenter cross-sectional study nested in a cohort of BRCA mutation carriers from 8 Dutch centers for hereditary cancer. Eligible participants are women who underwent RRSO before the age of 45. The participants will be frequency-matched on current age with women above the age of 55 without RRSO or with RRSO after the age of 55. Participants will complete an online questionnaire containing various questions about lifestyle, medical history, risk factors for cardiovascular disease, bone health, cognition and quality of life. Participants will be asked to visit one of the participating hospitals for a blood test, a cardiovascular assessment and a DEXA scan for determining bone mineral density. Afterwards participants will be requested to perform the online Amsterdam Cognition Scale.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Mineral Density | — | UNRESOLVED | — |
| BRCA1 Mutation | — | UNRESOLVED | — |
| BRCA2 Mutation | — | UNRESOLVED | — |
| Cardiovascular Diseases | — | UNRESOLVED | — |
| Cognitive Decline | — | UNRESOLVED | — |
| Menopause Surgical | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Surgical Menopause | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAC-score | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Early-RRSO
- description
- * RRSO before the age of 45 years * RRSO was done 10 or more years ago
- interventionNames
- Diagnostic Test: CAC-score
- label
- Late-/non-RRSO group
- description
- * Natural menopause ≥ 50 years of age * No RRSO ≤ age of 55 * No treatment-induced menopause ≤ 50 years of age
- interventionNames
- Diagnostic Test: CAC-score
Primary outcomes (9)
- measure
- What is the prevalence of atherosclerotic diseases in women with RRSO compared to women with a high genetic risk of ovarian cancer with a natural menopause as assessed by coronary artery calcium scoring in agatston units
- timeFrame
- 4 years
- description
- Due to the lack of estrogen we expect more atherosclerotic diseases.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * RRSO before age 45 * RRSO after age 55 * no RRSO Exclusion Criteria: * metastatic disease * Premature ovarian insufficiency * Physical or mental problems interfering with a outpatient visit * nonbioabsorbable cardiac stent * insufficient understanding of the Dutch language
References
Publications (5)
- DERIVEDBeekman MJ, Terra L, Bleiker EMA, Heemskerk-Gerritsen BAM, van Doorn HC, de Hullu JA, van Dorst EBL, Mom CH, van Beurden M, Slangen BFM, Mourits MJE, Roeters van Lennep JE, Gaarenstroom KN, van Engelen K, van der Kolk LE, Collee JM, Wevers MR, Ausems MGEM, Berger LPV, Gomez Garcia EB, van Asperen CJ, Maas AHEM, van Leeuwen FE, Hooning MJ. Long-term outcomes of surgical menopause after risk-reducing salpingo-oophorectomy: results of the HARMOny study. Maturitas. 2026 Apr;207:108882. doi: 10.1016/j.maturitas.2026.108882. Epub 2026 Feb 14. PMID 41724092
- DERIVEDBeekman MJ, Terra L, Stuursma A, Heemskerk-Gerritsen BAM, van Lennep JER, van Beurden M, van Doorn LC, de Hullu JA, van Dorst EBL, Mom CH, Slangen BFM, Mitea C, Slart RHJA, Snoeren MM, Stokkel MP, Verberne HJ, de Keizer B, Korse CM, Gaarenstroom KN, van Engelen K, van der Kolk LE, Collee JM, Wevers MR, Ausems MGEM, Berger LPV, Garcia EBG, van Asperen CJ, Hooning MJ, Maas AHEM, Mourits MJE, van Leeuwen FE, Zillikens MC. Long-term effects of premenopausal risk-reducing salpingo-oophorectomy on bone mineral density. Osteoporos Int. 2025 Nov;36(11):2307-2317. doi: 10.1007/s00198-025-07679-8. Epub 2025 Oct 4. PMID 41045325
- DERIVEDBeekman MJ, Terra L, Roeters van Lennep JE, Heemskerk-Gerritsen BAM, van Beurden M, van Doorn HC, de Hullu JA, van Dorst EBL, Mom CH, Slangen BFM, Mourits MJE, Gaarenstroom KN, van Engelen K, van der Kolk LE, Collee JM, Wevers MR, Ausems MGEM, Berger LPV, Gomez Garcia EB, van Asperen CJ, Hooning MJ, van Leeuwen FE, Maas AHEM. No increased arterial stiffness after premenopausal risk-reducing salpingo-oophorectomy (RRSO). Maturitas. 2025 Jun;197:108265. doi: 10.1016/j.maturitas.2025.108265. Epub 2025 Apr 11. PMID 40262388
- DERIVEDTerra L, Beekman MJ, Engelhardt EG, Heemskerk-Gerritsen BAM, van Beurden M, Roeters van Lennep JE, van Doorn HC, de Hullu JA, Van Dorst EBL, Mom CH, Slangen BFM, Gaarenstroom KN, van der Kolk LE, Collee JM, Wevers MR, Ausems MGEM, Van Engelen K, van de Beek I, Berger LPV, van Asperen CJ, Gomez Garcia EB, Maas AHEM, Hooning MJ, Aaronson NK, Mourits MJE, van Leeuwen FE. Sexual functioning more than 15 years after premenopausal risk-reducing salpingo-oophorectomy. Am J Obstet Gynecol. 2023 Apr;228(4):440.e1-440.e20. doi: 10.1016/j.ajog.2022.11.1289. Epub 2022 Nov 17.