NCT03835793: HARMOny

Health After eaRly Menopause Due to Oophorectomy

Status unknown Last updated 14 September 2020

What this trial tests

trial testing CAC-score in Surgical Menopause in 750 participants. Status unknown.

Timeline

11 February 2019

Primary endpoint
30 September 2021

1 January 2022

Quick facts

Lead sponsor	The Netherlands Cancer Institute
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	750
Start date	11 February 2019
Primary completion	30 September 2021
Estimated completion	1 January 2022
Sites	1 location across Netherlands

Drugs / interventions tested

• CAC-score

Conditions studied

• Surgical Menopause — all drugs for Surgical Menopause →
• BRCA1 Mutation — all drugs for BRCA1 Mutation →
• BRCA2 Mutation — all drugs for BRCA2 Mutation →
• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →

Sponsor

The Netherlands Cancer Institute

Who can join

55 and older, female only, with Surgical Menopause or BRCA1 Mutation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Long-Term Morbidity and Health After Early Menopause Due to Oophorectomy in Women at Increased Risk of Ovarian Cancer: Protocol for a Nationwide Cross-Sectional Study With Prospective Follow-Up (HARMOny Study).
   Terra L, Hooning MJ, Heemskerk-Gerritsen BAM, van Beurden M, et al · · 2021 · cited 15× · PMID 33480862 · DOI 10.2196/24414
2. Coronary Artery Calcium Scores After Prophylactic Premenopausal Bilateral Salpingo-Oophorectomy.
   Beekman MJ, Terra L, Heemskerk-Gerritsen BAM, van der Aalst CM, et al · · 2024 · cited 4× · PMID 39801648 · DOI 10.1016/j.jaccao.2024.09.011
3. Long-term effects of premenopausal risk-reducing salpingo-oophorectomy on bone mineral density.
   Beekman MJ, Terra L, Stuursma A, Heemskerk-Gerritsen BAM, et al · · 2025 · cited 2× · PMID 41045325 · DOI 10.1007/s00198-025-07679-8
4. No increased arterial stiffness after premenopausal risk-reducing salpingo-oophorectomy (RRSO).
   Beekman MJ, Terra L, Roeters van Lennep JE, Heemskerk-Gerritsen BAM, et al · · 2025 · cited 2× · PMID 40262388 · DOI 10.1016/j.maturitas.2025.108265
5. Long-term outcomes of surgical menopause after risk-reducing salpingo-oophorectomy: results of the HARMOny study.
   Beekman MJ, Terra L, Bleiker EMA, Heemskerk-Gerritsen BAM, et al · · 2026 · PMID 41724092 · DOI 10.1016/j.maturitas.2026.108882