Surgical MenopauseHARMOnyNCT03835793
Health After eaRly Menopause Due to Oophorectomy
An observational study of Surgical Menopause and BRCA1 Mutation, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 years and older, women only
- Conditions the study is for
- Surgical Menopause, BRCA1 Mutation, BRCA2 Mutation
- What is being tested?
- CAC-score
- How many people
- 750 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 Feb 2019to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- Women only
- Adult, Older adult
Study population: Women are eligible if they underwent RRSO before age 45 and the RRSO was done 10 or more years ago (early RRSO group) and women are eligible as control group if they did not undergo RRSO, or underwent RRSO after age 55 while reaching natural menopause after the age of 50 years. The comparison group will be frequency-matched with the RRSO group on categories of calendar year of birth, and breast cancer history. For each patient with breast cancer, the investigators will perform individual matching accounting for age at breast cancer diagnosis and carrier status. For the early RRSO group the investigators select women who underwent RRSO at least 10 years ago and are currently older than 55 years because the investigators expect subclinical atherosclerosis not to manifest earlier.
Who may be able to join
- RRSO before age 45
- RRSO after age 55
- no RRSO
Who cannot join
- metastatic disease
- Premature ovarian insufficiency
- Physical or mental problems interfering with a outpatient visit
- nonbioabsorbable cardiac stent
- insufficient understanding of the Dutch language
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Netherlands Cancer Institute - Antoni van Leeuwenhoek
Amsterdam, 1066CX
About this study
Official title: Favourable and Unfavourable Health Effects of Risk-Reducing Salpingo-Oophorectomy in Women With a High Genetic Risk of Ovarian Cancer
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.
Read the detailed description
Rationale: Women at high genetic risk of ovarian cancer are advised to undergo risk-reducing salpingo-oophorectomy (RRSO) at ages 35-45 years. Currently, in the Netherlands ~500 women/ year opt for RRSO, which minimizes ovarian cancer risk and may decrease breast cancer (BC) risk as well, due to reduced gonadal hormone levels. Besides favorable effects of RRSO on ovarian cancer and, potentially, BC risk, RRSO induces immediate menopause, which may have unfavorable long-term health consequences. Early menopause has been associated with increased risks of cardiovascular disease (CVD), lower bone mineral density (BMD), cognitive impairment, and decreased quality of life. Current evidence regarding these health effects is mainly based on women with a natural early menopause, and it is unknown whether these results hold for women undergoing RRSO at early premenopausal ages.
Objective: The investigators will investigate long-term health effects of premenopausal RRSO on (subclinical) cardiovascular status, BMD, cognition and quality of life.
Study design: the investigators will assess long-term health effects of RRSO in a cross-sectional study, among 500 women who underwent premenopausal RRSO compared to 250 women of the same age without RRSO (or with RRSO after age 55). Eligible women will be invited to participate in a screening program assessing cardiovascular status, bone mineral density, cognitive functioning and quality of life.
Study population: Women are eligible for the premenopausal RRSO group if:
- RRSO before the age of 45 years;
- RRSO was done 10 or more years ago; Women are eligible for the comparison group without premenopausal RRSO if the participant did not undergo RRSO before the age of 55 years, and did not have a natural or therapy induced menopause before age 50.
Primary study outcome: To study long-term effects of premenopausal RRSO on:
- (subclinical) CVD
- BMD
- Cognition
Secondary study outcome: To study long-term effects of premenopausal RRSO on:
- Quality of life
- Urogenital problems
- Cardiovascular risk factors
Furthermore, the investigators will examine the influence of age at RRSO, time since RRSO, hormone replacement therapy (HRT), carrier ship of a BRCA1 or BRCA2 mutation and BC history on the outcome.
The obtained knowledge will assist physicians in counselling women with high ovarian cancer risk and help them to make well-informed decisions.
- Conditions
- Surgical Menopause, BRCA1 Mutation, BRCA2 Mutation, Cardiovascular Diseases, Bone Mineral Density, Cognitive Decline
- Being tested
- CAC-score
- Keywords
- long-term, premature ovarian insufficiency
- Medical subject headings
- Cardiovascular Diseases, Cognitive Dysfunction, Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAC-scoreDiagnostic test
Also called Blood sampling, DXA-scan, Vertebral Fracture Assessment, Online cognition test (Amsterdam Cognition Scale)
Testing for possible unfavourable health effects of early surgical menopause
| Study group | Role | What they receive |
|---|---|---|
| Early-RRSO | * RRSO before the age of 45 years
* RRSO was done 10 or more years ago Receives: Diagnostic Test: CAC-score | |
| Late-/non-RRSO group | * Natural menopause ≥ 50 years of age
* No RRSO ≤ age of 55
* No treatment-induced menopause ≤ 50 years of age Receives: Diagnostic Test: CAC-score |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Due to the lack of estrogen we expect more atherosclerotic diseases.
Measured: 4 years
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 pulse wave velocity in meters/second
Due to the lack of estrogen we expect more atherosclerotic diseases.
Measured: 4 years
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 high-sensitive CRP in miligram/liter
Due to the lack of estrogen we expect more atherosclerotic diseases.
Measured: 4 years
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 high-sensitive cardial Troponine T in microgram/liter
Due to the lack of estrogen we expect more atherosclerotic diseases.
Measured: 4 years
What is the prevalence of osteoporosis in women with a premenopausal RRSO compared to women with a high genetic risk of ovarian cancer with a natural menopause as assessed by dual-energy X-ray absoptiometry in T- and Z-scores
Loss of estrogen can result in more activity of osteoclasts and less activity of osteoblasts, The DXA-scan is corrected for age, with lower values representing a worse outcome
Measured: 4 years
What is the prevalence of osteoporosis in women with a premenopausal RRSO compared to women with a high genetic risk of ovarian cancer with a natural menopause as assessed by instant vertebral assessment
Loss of estrogen can result in more activity of osteoclasts and less activity of osteoblasts
Measured: 4 years
What is the prevalence of osteoporosis in women with a premenopausal RRSO compared to women with a high genenetic risk of ovarian cancer with a natural menopause as assessed by beta-CTX in picogram/mililiter
Loss of estrogen can result in more activity of osteoclasts and less activity of osteoblasts
Measured: 4 years
What is the prevalence of osteoporosis in women with a premenopausal RRSO compared to women with a high genenetic risk of ovarian cancer with a natural menopause as assessed by P1NP in miligram/liter
Loss of estrogen can result in more activity of osteoclasts and less activity of osteoblasts
Measured: 4 years
What is the prevalence of cognitive decline in women with RRSO compared to women with a natural menopause as assessed by the Amsterdam Cognition Scan
There are some studies suggesting that an early menopause has an influence on cognition
Measured: 4 years
Secondary outcomes (7)
Quality of life after a premenopausal RRSO compared to women from families with a high genetic risk of ovarian cancer with a natural menopause as assessed by validated questionnaires such as the SF-36
How do women with a premenopausal RRSO experience their life. The SF-36 questionnaire ranges from 36 to 149, with higher values representing a worse outcome
Measured: 4 years
Quality of life after a premenopausal RRSO compared to women from families with a high genetic risk of ovarian cancer with a natural menopause as assessed by validated questionnaires such as the EORTC-QLQ BR23.
How do women with a premenopausal RRSO experience their life. We measure the body image using the EORTC QLQ BR23, with ranges from 2 to 8, with higher values representing a worse outcome
Measured: 4 years
Quality of life after a premenopausal RRSO compared to women from families with a high genetic risk of ovarian cancer with a natural menopause as assessed by validated questionnaires such as the FACT-ES
How do women with a premenopausal RRSO experience their life. The FACT-ES questionnaire ranges from 0 to 76, with higher values representing a worse outcome
Measured: 4 years
What is the prevalence of urogenital problems in women with a RRSO compared to women with a natural menopause as assessed by validated questionnaires such as the SAQ
Have women with a premenopausal RRSO more urogenital complaints due to longer duration of estrogen deficiency.
The SAQ questionnaire scale has questions with different weights as described in Thirlaway et al. 1996
Measured: 4 years
What is the prevalence of urogenital problems in women with a RRSO compared to women with a natural menopause as assessed by validated questionnaires such as the UDI-6
Have women with a premenopausal RRSO more urogenital complaints due to longer duration of estrogen deficiency.
The UDI-6 questionnaire scale has a range from 0 to 18, with higher values representing a worse outcome
Measured: 4 years
What is the prevalence of urogenital problems in women with a RRSO compared to women with a natural menopause as assessed by validated questionnaires such as the IIQ-7
Have women with a premenopausal RRSO more urogenital complaints due to longer duration of estrogen deficiency.
The IIQ-7 questionnaire scale has a range from 0 to 24, with higher values representing a worse outcome
Measured: 4 years
What is the prevalence of cardiovascular risk factors in women with RRSO compared to women with a high genetic risk of ovarian cancer as assessed by a questionnaire.
Are some risk factors for cardiovascular disease more prevalent in women with a premenopausal RRSO
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start11 Feb 2019
- Primary completion30 Sep 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Surgical MenopauseStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society, Erasmus Medical Center, Radboud University Medical Center
- Responsible party
- Sponsor
- Investigators
- Flora E van Leeuwen, Phd, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835793
- Sponsor's protocol ID
- M18HAR
- Acronym
- HARMOny
- Status last verified
- Sep 2020
- First submitted
- 19 Sep 2018
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Beekman 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.
PubMed 41724092Beekman 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.
PubMed 41045325Beekman 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.
PubMed 40262388Terra 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.
PubMed 36403862Terra L, Hooning MJ, Heemskerk-Gerritsen BAM, van Beurden M, Roeters van Lennep JE, van Doorn HC, de Hullu JA, Mom C, van Dorst EBL, Mourits MJE, Slangen BFM, Gaarenstroom KN, Zillikens MC, Leiner T, van der Kolk L, Collee M, Wevers M, Ausems MGEM, van Engelen K, Berger LP, van Asperen CJ, Gomez-Garcia EB, van de Beek I, Rookus MA, Hauptmann M, Bleiker EM, Schagen SB, Aaronson NK, Maas AHEM, van Leeuwen FE. 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). JMIR Res Protoc. 2021 Jan 22;10(1):e24414. doi: 10.2196/24414.
PubMed 33480862
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Favourable and Unfavourable Health Effects of Risk-Reducing Salpingo-Oophorectomy in Women With a High Genetic Risk of Ovarian Cancer
- ClinicalTrials.gov ID
- NCT03835793
- Acronym / sponsor ID
- HARMOny / M18HAR
- Conditions
- Surgical Menopause, BRCA1 Mutation, BRCA2 Mutation, Cardiovascular Diseases, Bone Mineral Density, Cognitive Decline
- Keywords
- long-term, premature ovarian insufficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Collaborators
- Dutch Cancer Society, Erasmus Medical Center, Radboud University Medical Center
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 11 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rationale: Women at high genetic risk of ovarian cancer are advised to undergo risk-reducing salpingo-oophorectomy (RRSO) at ages 35-45 years. Currently, in the Netherlands ~500 women/ year opt for RRSO, which minimizes ovarian cancer risk and may decrease breast cancer (BC) risk as well, due to reduced gonadal hormone levels. Besides favorable effects of RRSO on ovarian cancer and, potentially, BC risk, RRSO induces immediate menopause, which may have unfavorable long-term health consequences. Early menopause has been associated with increased risks of cardiovascular disease (CVD), lower bone mineral density (BMD), cognitive impairment, and decreased quality of life. Current evidence regarding these health effects is mainly based on women with a natural early menopause, and it is unknown whether these results hold for women undergoing RRSO at early premenopausal ages.
Objective: The investigators will investigate long-term health effects of premenopausal RRSO on (subclinical) cardiovascular status, BMD, cognition and quality of life.
Study design: the investigators will assess long-term health effects of RRSO in a cross-sectional study, among 500 women who underwent premenopausal RRSO compared to 250 women of the same age without RRSO (or with RRSO after age 55). Eligible women will be invited to participate in a screening program assessing cardiovascular status, bone mineral density, cognitive functioning and quality of life.
Study population: Women are eligible for the premenopausal RRSO group if:
- RRSO before the age of 45 years;
- RRSO was done 10 or more years ago; Women are eligible for the comparison group without premenopausal RRSO if the participant did not undergo RRSO before the age of 55 years, and did not have a natural or therapy induced menopause before age 50.
Primary study outcome: To study long-term effects of premenopausal RRSO on:
- (subclinical) CVD
- BMD
- Cognition
Secondary study outcome: To study long-term effects of premenopausal RRSO on:
- Quality of life
- Urogenital problems
- Cardiovascular risk factors
Furthermore, the investigators will examine the influence of age at RRSO, time since RRSO, hormone replacement therapy (HRT), carrier ship of a BRCA1 or BRCA2 mutation and BC history on the outcome.
The obtained knowledge will assist physicians in counselling women with high ovarian cancer risk and help them to make well-informed decisions.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early-RRSO | – | Diagnostic Test: CAC-score* RRSO before the age of 45 years * RRSO was done 10 or more years ago |
| Late-/non-RRSO group | – | Diagnostic Test: CAC-score* Natural menopause ≥ 50 years of age * No RRSO ≤ age of 55 * No treatment-induced menopause ≤ 50 years of age |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women are eligible if they underwent RRSO before age 45 and the RRSO was done 10 or more years ago (early RRSO group) and women are eligible as control group if they did not undergo RRSO, or underwent RRSO after age 55 while reaching natural menopause after the age of 50 years. The comparison group will be frequency-matched with the RRSO group on categories of calendar year of birth, and breast cancer history. For each patient with breast cancer, the investigators will perform individual matching accounting for age at breast cancer diagnosis and carrier status. For the early RRSO group the investigators select women who underwent RRSO at least 10 years ago and are currently older than 55 years because the investigators expect subclinical atherosclerosis not to manifest earlier.
Key inclusion criteria (3 listed)
- RRSO before age 45
- RRSO after age 55
- no RRSO
Key exclusion criteria (5 listed)
- metastatic disease
- Premature ovarian insufficiency
- Physical or mental problems interfering with a outpatient visit
- nonbioabsorbable cardiac stent
- insufficient understanding of the Dutch language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAC-scoreAlso: Blood sampling, DXA-scan, Vertebral Fracture Assessment, Online cognition test (Amsterdam Cognition Scale)Testing for possible unfavourable health effects of early surgical menopause | Diagnostic test | Early-RRSO, Late-/non-RRSO group |
Primary outcome
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
Time frame: 4 years
Due to the lack of estrogen we expect more atherosclerotic diseases.
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 pulse wave velocity in meters/second
Time frame: 4 years
Due to the lack of estrogen we expect more atherosclerotic diseases.
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 high-sensitive CRP in miligram/liter
Time frame: 4 years
Due to the lack of estrogen we expect more atherosclerotic diseases.
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 high-sensitive cardial Troponine T in microgram/liter
Time frame: 4 years
Due to the lack of estrogen we expect more atherosclerotic diseases.
What is the prevalence of osteoporosis in women with a premenopausal RRSO compared to women with a high genetic risk of ovarian cancer with a natural menopause as assessed by dual-energy X-ray absoptiometry in T- and Z-scores
Time frame: 4 years
Loss of estrogen can result in more activity of osteoclasts and less activity of osteoblasts, The DXA-scan is corrected for age, with lower values representing a worse outcome
What is the prevalence of osteoporosis in women with a premenopausal RRSO compared to women with a high genetic risk of ovarian cancer with a natural menopause as assessed by instant vertebral assessment
Time frame: 4 years
Loss of estrogen can result in more activity of osteoclasts and less activity of osteoblasts
What is the prevalence of osteoporosis in women with a premenopausal RRSO compared to women with a high genenetic risk of ovarian cancer with a natural menopause as assessed by beta-CTX in picogram/mililiter
Time frame: 4 years
Loss of estrogen can result in more activity of osteoclasts and less activity of osteoblasts
What is the prevalence of osteoporosis in women with a premenopausal RRSO compared to women with a high genenetic risk of ovarian cancer with a natural menopause as assessed by P1NP in miligram/liter
Time frame: 4 years
Loss of estrogen can result in more activity of osteoclasts and less activity of osteoblasts
What is the prevalence of cognitive decline in women with RRSO compared to women with a natural menopause as assessed by the Amsterdam Cognition Scan
Time frame: 4 years
There are some studies suggesting that an early menopause has an influence on cognition
7 secondary outcomes
Quality of life after a premenopausal RRSO compared to women from families with a high genetic risk of ovarian cancer with a natural menopause as assessed by validated questionnaires such as the SF-36
Time frame: 4 years
Quality of life after a premenopausal RRSO compared to women from families with a high genetic risk of ovarian cancer with a natural menopause as assessed by validated questionnaires such as the EORTC-QLQ BR23.
Time frame: 4 years
Quality of life after a premenopausal RRSO compared to women from families with a high genetic risk of ovarian cancer with a natural menopause as assessed by validated questionnaires such as the FACT-ES
Time frame: 4 years
What is the prevalence of urogenital problems in women with a RRSO compared to women with a natural menopause as assessed by validated questionnaires such as the SAQ
Time frame: 4 years
What is the prevalence of urogenital problems in women with a RRSO compared to women with a natural menopause as assessed by validated questionnaires such as the UDI-6
Time frame: 4 years
What is the prevalence of urogenital problems in women with a RRSO compared to women with a natural menopause as assessed by validated questionnaires such as the IIQ-7
Time frame: 4 years
What is the prevalence of cardiovascular risk factors in women with RRSO compared to women with a high genetic risk of ovarian cancer as assessed by a questionnaire.
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
- Derived from this study: PubMed 41724092Beekman 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.
- Derived from this study: PubMed 41045325Beekman 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.
- Derived from this study: PubMed 40262388Beekman 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.
- Derived from this study: PubMed 36403862Terra 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.
- Derived from this study: PubMed 33480862Terra L, Hooning MJ, Heemskerk-Gerritsen BAM, van Beurden M, Roeters van Lennep JE, van Doorn HC, de Hullu JA, Mom C, van Dorst EBL, Mourits MJE, Slangen BFM, Gaarenstroom KN, Zillikens MC, Leiner T, van der Kolk L, Collee M, Wevers M, Ausems MGEM, van Engelen K, Berger LP, van Asperen CJ, Gomez-Garcia EB, van de Beek I, Rookus MA, Hauptmann M, Bleiker EM, Schagen SB, Aaronson NK, Maas AHEM, van Leeuwen FE. 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). JMIR Res Protoc. 2021 Jan 22;10(1):e24414. doi: 10.2196/24414.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Flora E van Leeuwen, Phd principal investigator
The Netherlands Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Menopause and BRCA1 Mutation, run by The Netherlands Cancer Institute at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 4 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03835793, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2020.