NCT07406412 Hormonal Regulation of Cardiometabolic Health Study
| NCT ID | NCT07406412 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Jyvaskyla |
| Condition | Menopause Surgical |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-02-13 |
| Primary Completion | 2028-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2026-02-13 with a primary completion date of 2028-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
Contact & Investigator
Eija K Laakkonen, Associate Professor
PRINCIPAL INVESTIGATOR
University of Jyvaskyla
Frequently Asked Questions
Who can join the NCT07406412 clinical trial?
This trial is open to female participants only, aged 35 Years or older, up to 50 Years, studying Menopause Surgical. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07406412 currently recruiting?
Yes, NCT07406412 is actively recruiting participants. Contact the research team at eija.k.laakkonen@jyu.fi for enrollment information.
Where is the NCT07406412 trial being conducted?
This trial is being conducted at Helsinki, Finland, Jyväskylä, Finland, Jyväskylä, Finland, Kuopio, Finland and 3 additional locations.
Who is sponsoring the NCT07406412 clinical trial?
NCT07406412 is sponsored by University of Jyvaskyla. The principal investigator is Eija K Laakkonen, Associate Professor at University of Jyvaskyla. The trial plans to enroll 120 participants.