Hormonal Regulation of Cardiometabolic Health Study

NCT07406412 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

  • Menopause Surgical

Interventions

PROCEDURE

Surgical removal of ovaries

Bilateral oophorectomy, or unilateral if only one ovary remains. Other organs may also be removed during the same procedure, such as fallopian tubes (salpingectomy) and/or uterus (hysterectomy).

DRUG

Hormone Replacement Therapy (HRT)

Post-surgery HRT as part of clinical treatment after the 1-2 month follow-up. HRT may be any commercially available systemic treatment.

Sponsors & Collaborators

  • Wellbeing Services County of Central Finland

    collaborator UNKNOWN
  • Wellbeing Services County of North Savo

    collaborator UNKNOWN
  • Wellbeing Services County of Pirkanmaa

    collaborator OTHER
  • Wellbeing Services County of Southwest Finland

    collaborator UNKNOWN
  • Wellbeing Services County of North Ostrobothnia

    collaborator UNKNOWN
  • Hospital District of Helsinki and Uusimaa

    collaborator OTHER
  • University of Jyvaskyla

    lead OTHER

Principal Investigators

  • Eija K Laakkonen, Associate Professor · University of Jyvaskyla

Eligibility

Min Age
35 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-13
Primary Completion
2028-12-15
Completion
2028-12-15

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07406412 on ClinicalTrials.gov