Health Trials

Oxytocin in Postmenopausal Women

ConditionsPostmenopausalPremenopausal
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity Hospital, Basel, Switzerland

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female sex at birth

Age ≥18 years

Disqualifiers

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

Trial population

Gender is restricted to female at birht participants. Perimenopausal women and women using hormonal medication are excluded.Pregnant or lactating women were excluded due to altered oxytocin physiology and ethical considerations.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Repeated assessments

    Other intervention

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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Postmenopausal1 intervention
Group B: Premenopausal1 intervention

Trial outcomes

Primary outcomes

1

Area under the curve of Neurophysin-1 (NP-I)

The primary endpoint is the Area under the curve (AUC) of circulating plasma NP-I assessed over four standardized study visits within one month, corresponding to mid-menstruation, mid-follicular phase, ovulation, and mid-luteal phase in premenopausal women, and four weekly visits in postmenopausal women. The primary comparison will be the NP-I AUC between premenopausal and postmenopausal participants

Time frame
1 month

Secondary outcomes

1

Cycle-phase-specific OXT/NP-I concentrations

Phase-specific plasma OXT/NP-I concentrations at each study visit

Time frame
1 month
2

Gonadal Hormone concentrations

Estradiol for confirmation of cycle phase and assessment of hormonal correlates

Time frame
1 month
3

Psychological and affective measures - anxiety

Perceived anxiety symptoms assessed by validated questionnaires (State-Trait Anxiety Inventory). The State-Trait Anxiety Inventory score measures general trait anxiety using a 20-item subscale rated on a 1-to-4 scale. Total scores range from 20 to 80, with higher numbers showing greater general anxiety.

Time frame
1 month
4

Psychological and affective measures - depression

Perceived depressive symptoms assessed by validated questionnaires (Becks Depression Inventory-II). The Beck Depression Inventory-II total score ranges from 0 to 63. Standard severity thresholds are minimal depression (0-13), mild depression (14-19), moderate depression (20-28), and severe depression (29-63).

Time frame
1 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Basel, Switzerland

Lead sponsor

Source ClinicalTrials.gov
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