Hormonal Regulation of Cardiometabolic Health Study

Recruiting now

Conditions studied: Menopause Surgical

In brief

The goal of this observational study is to understand how the loss of ovarian function after oophorectomy affects the health and well being of women aged 35-50. The study focuses on four areas: 1. Quality of life and embodied experience, 2. Cardiometabolic health, 3. Central nervous system function, and 4. Adipose tissue health and cellular function. Our primary goal is to understand the effects of oophorectomy on women's health in focus areas 1 to 3. To do this, we will compare women's health before surgery with follow up assessments at 1-2 months and 12 months after surgery. Some participants may start hormone replacement therapy (HRT) during follow up as part of their routine care; this is outside the study protocol. As an exploratory aim, we will examine whether 12 month outcomes-or the change from baseline to 12 months-differ between participants who begin HRT and those who do not. Focus area 4 provides an opportunity to explore how molecular and cellular mechanisms in adipose tissue respond to the loss of ovarian hormones. These analyses are exploratory and intended to offer mechanistic insight rather than clinical endpoints. Participants will: * undergo bilateral (or unilateral, if only one ovary remains) oophorectomy as part of their clinical treatment, * complete questionnaires and physiological measurements at three time points, * a subgroup will participate in qualitative interviews about their lived experience of surgical menopause, * and a subgroup will volunteer adipose tissue samples collected during surgery.

Key facts

Study ID

NCT07406412

Run by

University of Jyvaskyla

People needed

120

Starts

2026-02-13

Expected to finish

2028-12-15

Last updated by the study team

2026-05-06

Who can join

Age: 35 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Age 35-50 years
• Pre- or perimenopausal status (defined as self-reported menstrual bleedings and/or follicle-stimulating hormone ≤25 IU/L)
• One or two functional ovaries
• Planning to undergo bilateral oophorectomy or salpingo-oophorectomy (BSO) or unilateral oophorectomy or salpingo-oophorectomy (SO) if the other ovary has been previously removed, for non-malignant reasons

You may not qualify if…

• Oophorectomy due to ovarian cancer or other malignant conditions
• Current systemic estrogen-containing medication
• The following exclusion criteria apply only to participation in physiological assessments (not questionnaires or interviews):
• Severe heart or liver disease
• Mobility limitations that prevent participation in physical exercise tests
• The following factors do not lead to exclusion but will be recorded and considered in analyses:
• Use of medications such as weight reduction drugs, lipid-lowering agents, or antihypertensives
• Concomitant hysterectomy or other surgeries performed with oophorectomy
• Use of local vaginal oestrogen therapy
• Initiation of systemic hormone replacement therapy (HRT) after the 1-2-month post-surgery assessments (allowed according to clinical need; not part of the study protocol)

Where it is running

• Wellbeing Services County of North Savo — Kuopio, Finland (enrolling)
• Wellbeing Services County of Central Finland — Jyväskylä, Finland (enrolling)
• Wellbeing Services County of Pirkanmaa — Tampere, Finland (enrolling)
• Wellbeing Services County of Southwest Finland — Turku, Finland (enrolling)
• University of Jyväskylä — Jyväskylä, Finland
• Wellbeing Services County of North Ostrobothnia — Oulu, Finland
• HUS — Helsinki, Finland

Full record on ClinicalTrials.gov

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