Hormonal Regulation of Cardiometabolic Health Study

NCT07406412 | Recruiting

• 1 other identifier: 2U/2025/HoCa
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 7

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:

• 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

Keywords

Oophorectomy; Menopause; Estrogen Deficiency; Cardiometabolic Health; Quality of Life; Body Composition; Physical performance; Neurophysiology; Prospective observational study; Embodied experience; Health behavior; Adipose Tissue; Fat Oxidation; Vascular function; Menopause symptoms

Outcome Measures

Primary Outcomes (5)

• Change from Baseline in RAND-36 Item Health Survey (RAND-36) Total Score

  The RAND-36 Item Health Survey is a 36-item health-related quality of life instrument with eight domains: Physical Functioning, Role Limitations due to Physical Health, Bodily Pain, General Health, Vitality, Social Functioning, Role Limitations due to Emotional Problems, and Emotional Well-Being. Each domain is scored on a 0-100 scale; higher scores indicate better health status. The RAND-36 total score is computed as the arithmetic mean of the eight domain scores (range 0-100; higher = better). The reported measure is the change from baseline to follow-up (follow-up minus baseline); positive values indicate improvement. Scoring follows the instrument manual and the Statistical Analysis Plan (SAP). A prespecified sensitivity analysis may use a reduced/composite RAND-36 score (e.g., a domain subset with documented performance advantages); details are specified in the SAP. This sensitivity analysis is supportive and does not replace the prespecified analysis of this primary outcome.

  Baseline to 1-2 months and 12 months post-surgery

• Change from Baseline in Menopause Rating Scale (MRS) Score

  The Menopause Rating Scale (MRS) is an 11-item questionnaire assessing menopausal symptom burden across three domains: Somatic (4 items), Psychological (4 items), and Urogenital (3 items). Each item is scored 0-4 (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe), yielding a total score range of 0-44, where higher scores indicate worse symptom severity/health-related quality of life. The outcome is the change from baseline to the specified follow-up time point (follow-up minus baseline); positive values indicate worsening and negative values indicate improvement. Scoring follows the instrument manual and the Statistical Analysis Plan (SAP). A prespecified sensitivity analysis may use a reduced MRS score that excludes items with documented suboptimal performance; details are specified in the Statistical Analysis Plan. This sensitivity analysis is supportive and does not replace the prespecified analysis of this primary outcome.

  Baseline to 1-2 months and 12 months post-surgery

• Change from Baseline in Resting Energy Expenditure (REE, kcal/day) Measured by Indirect Calorimetry

  Resting energy expenditure (REE) is measured by indirect calorimetry (ventilated hood; overnight fast 10-12 h; supine, thermoneutral room). After stabilization, VO2 and VCO2 are recorded for ≥20-30 min; a steady-state segment (e.g., ≥5 min with CV \<10% and physiologic RQ) is used to compute REE (kcal/day) via the Weir equation, higher values = higher energy expenditure. Outcome is change from baseline to follow-up (follow-up - baseline); higher positive values = higher increase in energy expenditure. Procedures/quality criteria follow the device manual and the Statistical Analysis Plan (SAP). Per SAP, supportive analyses may adjust for body composition (FFM/FM) or express REE relative to FFM; these do not replace the prespecified analysis of this primary outcome.

  Baseline to 1-2 months and 12 months post-surgery

• Change from Baseline in Total Fat Mass (kg) Measured by Bioelectrical Impedance Analysis

  Total fat mass (FM) will be measured by bioelectrical impedance analysis (BIA; InBody) under standardized conditions, including a 10-12 h fast before assessment. FM is reported in kg; higher values indicate higher fat mass. The outcome is the change from baseline to the specified follow-up (follow-up - baseline). Measurement procedures, quality criteria, and handling of missing/outliers follow the device manual and the Statistical Analysis Plan (SAP). Per SAP, a prespecified sensitivity analysis will estimate FM using DXA (where available); this analysis is supportive and does not replace the prespecified analysis of this primary outcome.

  Baseline to 1-2 months and 12 months post-surgery

• Change from Baseline in Aortic Pulse Wave Velocity (PWV, m/s)

  Aortic pulse wave velocity (PWV) will be measured using an oscillometric Arteriograph device under standardized resting conditions, including a 10-12 h fast and avoidance of vigorous physical activity during the previous 24 h. Measurements are taken supine in a quiet, thermoneutral room. PWV is reported in m/s; higher values indicate greater arterial stiffness. The outcome is the change from baseline to the specified follow-up (follow-up - baseline). Procedures, calibration, and quality criteria follow the device manual and the Statistical Analysis Plan (SAP). Per SAP, supportive analyses may examine additional Arteriograph variables (e.g., AIx, aortic pressures); these do not replace the prespecified analysis of this primary outcome.

  Baseline to 1-2 months and 12 months post-surgery

Secondary Outcomes (9)

• Change from Baseline in Women's Health Questionnaire (WHQ) Total Score (36-item)

  Baseline to 1-2 months and 12 months post-surgery

• Change from baseline in the Pelvic Floor Distress Inventory-20 (PFDI-20) total score (20-item)

  Baseline to 1-2 months and 12 months post-surgery

• Change from Baseline in Athens Insomnia Scale-5 (AIS-5) Score

  Baseline to 1-2 months and 12 months post-surgery

• Change from Baseline in Fat-Free Mass (kg) Measured by Bioelectrical Impedance Analysis

  Baseline to 1-2 months and 12 months post-surgery

• Change from Baseline in Augmentation Index (AIx, %)

  Baseline to 1-2 months and 12 months post-surgery

Other Outcomes (37)

• Change from Baseline in 15D Health-Related Quality of Life (15D) Index Score

  Baseline to 1-2 months and 12 months post-surgery

• Change from Baseline in Female Sexual Function Index (FSFI) Total Score

  Baseline to 1-2 months and 12 months post-surgery

• Change from Baseline in Center for Epidemiological Studies Depression Scale (CES-D) Total Score

  Baseline to 1-2 months and 12 months post-surgery

Study Arms (1)

Surgical Menopause Cohort

Women aged 35-50 undergoing bilateral (or unilateral, if one ovary remains) oophorectomy for non-malignant indications.

Procedure: Surgical removal of ovaries; Drug: Hormone Replacement Therapy (HRT)

Interventions

Hormone Replacement Therapy (HRT) DRUG

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

Also known as: systemic menopausal hormone therapy; MHT

Surgical Menopause Cohort

Surgical removal of ovaries PROCEDURE

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).

Also known as: oophorectomy

Surgical Menopause Cohort

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from gynaecological surgical waiting lists at the university and central hospitals across Finland. Recruitment sites include the Wellbeing Service counties of Central Finland, North Savo, Pirkanmaa, Southwest Finland, and North Ostrobothnia, as well as the Hospital District of Helsinki and Uusimaa (HUS).

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
• Severe heart or liver disease
• Mobility limitations that prevent participation in physical exercise tests
• 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)

Sponsors & Collaborators

• University of Jyvaskyla: lead
• Wellbeing Services County of Central Finland: collaborator
• Wellbeing Services County of North Savo: collaborator
• Wellbeing Services County of Pirkanmaa: collaborator
• Wellbeing Services County of Southwest Finland: collaborator
• Wellbeing Services County of North Ostrobothnia: collaborator
• Hospital District of Helsinki and Uusimaa: collaborator

Study Sites (7)

HUS

Helsinki, 00290, Finland

NOT YET RECRUITING

University of Jyväskylä

Jyväskylä, 40014, Finland

ACTIVE NOT RECRUITING

Wellbeing Services County of Central Finland

Jyväskylä, 70210, Finland

RECRUITING

Wellbeing Services County of North Savo

Kuopio, 70210, Finland

RECRUITING

Wellbeing Services County of North Ostrobothnia

Oulu, 90029, Finland

NOT YET RECRUITING

Wellbeing Services County of Pirkanmaa

Tampere, 33520, Finland

RECRUITING

Wellbeing Services County of Southwest Finland

Turku, 20520, Finland

RECRUITING

Related Links

• Home page of the HoCa study

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples will be collected for leukocyte and platelet analyses, including flow cytometry and transcriptomic profiling (microRNA and mRNA). Plasma and serum samples will be retained for biomarker assays related to hormonal, metabolic, and inflammatory status. Samples will be obtained at rest and after a standardised cycle ergometer test to assess exercise-induced responses. In addition, subcutaneous and visceral adipose tissue samples collected during oophorectomy will be used for organoid-based studies of adipose tissue health and cellular function.

MeSH Terms

Conditions

Health Behavior

Interventions

Ovariectomy; Hormone Replacement Therapy; mahuang-tang

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Castration; Endocrine Surgical Procedures; Surgical Procedures, Operative; Urogenital Surgical Procedures; Gynecologic Surgical Procedures; Drug Therapy; Therapeutics

Study Officials

• Eija K Laakkonen, Associate Professor

  University of Jyvaskyla

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eija K Laakkonen, Associate Professor

CONTACT

+358-40-8053588; eija.k.laakkonen@jyu.fi

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: February 12, 2026
• Study Start: February 13, 2026
• Primary Completion (Estimated): December 15, 2028
• Study Completion (Estimated): December 15, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FI (7)