Hormonal Regulation of Cardiometabolic Health Study

What this trial studies

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.

Conditions in scope

• Menopause Surgical

Interventions

• 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).
• 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.

Who can join

Women only · Ages 35 Years to 50 Years

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
• 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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Observational
• Phase: N/A
• Start date: 2026-02-13
• Primary completion: 2028-12-15
• Last update posted: 2026-05-06
• First posted: 2026-02-12

Sponsor & contact

Lead sponsor: University of Jyvaskyla (Other)

Collaborators: Wellbeing Services County of Central Finland, Wellbeing Services County of North Savo, Wellbeing Services County of Pirkanmaa, Wellbeing Services County of Southwest Finland, Wellbeing Services County of North Ostrobothnia, Hospital District of Helsinki and Uusimaa

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Change from Baseline in RAND-36 Item Health Survey (RAND-36) Total Score (Baseline to 1-2 months and 12 months post-surgery)
  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…
• Change from Baseline in Menopause Rating Scale (MRS) Score (Baseline to 1-2 months and 12 months post-surgery)
  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…
• Change from Baseline in Resting Energy Expenditure (REE, kcal/day) Measured by Indirect Calorimetry (Baseline to 1-2 months and 12 months post-surgery)
  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…
• Change from Baseline in Total Fat Mass (kg) Measured by Bioelectrical Impedance Analysis (Baseline to 1-2 months and 12 months post-surgery)
  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…
• Change from Baseline in Aortic Pulse Wave Velocity (PWV, m/s) (Baseline to 1-2 months and 12 months post-surgery)
  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…

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.