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Impact of risk-reducing bilateral salpingo-oophorectomy on non-cancer outcomes in young high-risk women: A multicentre prospective study

A prospective study on the effects of risk-reducing bilateral salpingo-oophorectomy (RRBSO) in pre-menopausal women at risk of developing ovarian cancer on non-cancer outcomes including sexual function and menopause related quality of life.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12615000082505
Acronym
WHAM - Women's Health After surgical Menopause
Enrollment
224
Registered
2015-02-02
Start date
2013-03-26
Completion date
2019-02-08
Last updated
2022-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The study is evaluating the impact of risk-reducing bilateral salpingo-oophorectomy (RRBSO) on sexual function, menopause symptoms and quality of life issues, bone health, cardiovascular health, sleep quality, depression/anxiety symptoms and cognitive function in high-risk, pre-menopausal women. Who is it for? You may be eligible to join this study if you are aged between 18 years old (inclusive) and 50 years old (inclusive), at a high risk of developing breast and/or ovarian cancer, have regular menstrual periods if your uterus is intact, no current vasomotor symptoms (e.g. hot flushes and night sweats), early follicular follicle-stimulation hormone (FSH) of equal to or less than 15 IU/L, Estradiol > 100pmol/L, and are planning to have RRBSO. Women who are not planning to have RRBSO or become pregnant in the next 2 years, and fit the same eligibility criteria are also asked to participate. They will form an age matched control. Trial design. Participants in this study will be required to undergo blood tests and bone mineral density scanning at baseline and then repeated on an annual basis for 2 years. Participants will also need to complete questionnaires relating to sexual function, menopause, depression/anxiety, and sleep quality at baseline, 3 months, 6 months, 12 months and 24 months. Participants will also have tests to measure cognitive function at baseline, 3 months, 12 months and 24 months.

Interventions

Women at risk of developing ovarian and/or breast cancer who have undergone RRBSO. Non-cancer outcomes including sexual function, menopause symptoms and quality of life issues, bone health, cardiovascular health, sleep quality, depression/anxiety symptoms and cognitive function will be assessed using the following: Blood tests performed at baseline, 12 & 24 months. Time required = 1/2 hour x 3 episodes. Total time =1 and 1/2 hours Bone mineral density scanning x 3 occasions (baseline, 12 and 24

Women at risk of developing ovarian and/or breast cancer who have undergone RRBSO. Non-cancer outcomes including sexual function, menopause symptoms and quality of life issues, bone health, cardiovascular health, sleep quality, depression/anxiety symptoms and cognitive function will be assessed using the following: Blood tests performed at baseline, 12 & 24 months. Time required = 1/2 hour x 3 episodes. Total time =1 and 1/2 hours Bone mineral density scanning x 3 occasions (baseline, 12 and 24 months) at 1 hour each. Total time = 3 hours. Completion of questionnaires (N=8) x 5 occasions (baseline, 3, 6, 12 and 24 months) at 1/2 hour each. Total time = 2 hours. Short question and answer tests to measure cognitive function x 3 occasions (baseline, 12 and 24 months) at 45 mins each. Total time = 2 and 1/4 hours.

Sponsors

Peter MacCallum Cancer Centre
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

Aged 18 - 50 years Regular menstrual periods (if intact uterus) No current vasomotor symptoms (hot flushes and night sweats) Early follicular FSH of equal to or less than 15 UI/L Estradiol > 100 pmol/L At a high risk of developing breast and/or ovarian cancer Planning to undergo RRBSO

Exclusion criteria

Previous bilateral salpingo-oophorectomy Taking anti-estrogen agents or tamoxifen in the previous 3 months Lactating or within 3 months of pregnancy English non-speakers Undiagnosed abnormal vaginal bleeding Current pregnancy (to be excluded with pregnancy test where indicated)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 25, 2026