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Oxytocin in Postmenopausal Women

Observational Postmenopausal Premenopausal

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Repeated assessments.
Who it may be relevant to
Registry conditions: Postmenopausal, Premenopausal. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Circulating Oxytocin and Its Clinical Correlates in Postmenopausal Women Compared With Premenopausal Controls - The OxyMENO Study

Overview

The aim of the present study is to assess whether cumulative endogenous neurophysin I secretion over one month differs between premenopausal and postmenopausal women. Using repeated measurements of neurophysin-I (NP-I, equimolar surrogate marker of oxytocin) across defined physiological time points, this study investigates oxytocin system regulation under cyclic and non-cyclic hormonal conditions. The primary hypothesis is that cumulative NP-I release, expressed as the area under the curve (AUC) is lower in the postmenopausal group compared to the premenopausal group.

Detailed description

Oxytocin (OXT) plays a key role in pair-bonding behavior, social cognition, stress regulation and emotional processing, while peripherally it regulates parturition, lactation, and smooth muscle function. Beyond reproductive physiology, OXT has been implicated in numerous other metabolic functions. It has been suggested to exert cardioprotective effects, including attenuation of cardiac apoptosis and fibrosis, negative chronotropic and inotropic actions \[7\], and anti-inflammatory effects. Furthermore, it has been associated with the regulation of glucose homeostasis and pain perception.

In women, elevated OXT levels have been suggested to enhance cognitive control over food cravings. While a clinical study including 55 women examined postprandial OXT levels across different menstrual phases, data on fasting OXT levels across an entire cycle in premenopausal women, as well as comparisons with postmenopausal women, remain scarce. In general, most research on the relation between OXT and food intake has been done outside the context of the menstrual cycle or in clinical populations (e.g. patients with bulimia nervosa).

The synthesis, release and expression of OXT are modulated by sex steroids, particularly estrogen. Across the menstrual cycle, circulating OXT levels exhibit dynamic changes in women of reproductive age. Menopause, however, is characterized by complete cessation of ovarian function leading to sustained estrogen deficiency and loss of cyclical hormonal regulation. A longitudinal assessment of circulating OXT across a physiological menstrual cycle, compared with repeated measurements in postmenopausal women, may provide a more robust characterization of OXT secretion patterns. Quantifying NP-I release over time using the area under the curve (AUC) may overcome limitations of single time-point measurements and improve understanding of menopause-related alterations in OXT physiology. The aim of the present study is to assess whether cumulative endogenous NP-I secretion (equimolar OXT surrogate marker) over one month differs between premenopausal and postmenopausal women

Interventions

  • Other Repeated assessments
    This study is an observational investigation involving repeated venous blood sampling and non-invasive clinical assessments ov four study visits.

Primary outcome measures

  • Area under the curve of Neurophysin-1 (NP-I) [Time frame: 1 month]
Secondary outcome measures (12)
  • Cycle-phase-specific OXT/NP-I concentrations [Time frame: 1 month]
  • Gonadal Hormone concentrations [Time frame: 1 month]
  • Psychological and affective measures - anxiety [Time frame: 1 month]
  • Psychological and affective measures - depression [Time frame: 1 month]
  • Psychological and affective measure - sleep quality [Time frame: 1 month]
  • Climacteric symptoms [Time frame: 1 month]
  • Emotion recognition performance [Time frame: 1 month]
  • Empathy [Time frame: 1 month]
  • Socio-affective processing [Time frame: 1 month]
  • Stress reactivity - subjective stress rating [Time frame: 1 month]
  • Stress reactivity - autonomic measures [Time frame: 1 month]
  • Stress reactivity - endocrine stress markers [Time frame: 1 month]

Eligibility criteria

Inclusion criteria

  • Female sex at birth
  • Age ≥18 years

Premenopausal group:

  • Premenopausal women aged 18-35 years with regular menstrual cycles (21-35 days) for ≥3 months prior to study entry

Postmenopausal group:

  • Postmenopausal women ≥2 years of postmenopause (i.e. 3 years since last menstrual period (LMP), with menopause defined as ≥ 12 months of amenorrhea)

Exclusion criteria

  • Pregnancy or breastfeeding
  • Use of hormonal contraception or hormone replacement therapy within the last 3 months
  • Known endocrine disorders affecting the hypothalamic-pituitary-gonadal axis
  • Use of medications
  • Severe depression (BDI score > 28 points), any other severe psychiatric illness or acute medical disease
  • Inability to comply with study procedures
  • Participation in a trial with investigational drugs within the last 30 days

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Switzerland · 1 center
  • University Hospital Basel — Basel

Identifiers

NCT: NCT07742124 · 2026-01136 - kt26ChristCrain4

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗