Oxytocin in Postmenopausal Women

NCT07742124 | Not Yet Recruiting

• 1 other identifier: 2026-01136 - kt26ChristCrain4
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postmenopausal; Premenopausal

Keywords

Oxytocin; Postmenopausal; Premenopausal; Neurophysin-I; cyclic hormonal condition; menstrual cyclic phase

Outcome Measures

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

  1 month

Secondary Outcomes (33)

• Cycle-phase-specific OXT/NP-I concentrations

  1 month

• Gonadal Hormone concentrations

  1 month

• Psychological and affective measures - anxiety

  1 month

• Psychological and affective measures - depression

  1 month

• Psychological and affective measure - sleep quality

  1 month

Study Arms (2)

Postmenopausal

Postmenopausal women, visits will take place during the menstrual phase, mid-follicular phase, ovulation, and mid-luteal phase, with a scheduling tolerance of ± 2days.

Other: Repeated assessments

Premenopausal

Premenopausal women, visits will take place during the menstrual phase, mid-follicular phase, ovulation, and mid-luteal phase, with a scheduling tolerance of ± 2days.

Other: Repeated assessments

Interventions

Repeated assessments OTHER

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

Postmenopausal; Premenopausal

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Gender is restricted to female participants, as sex differences in reproductive endocrinology and oxytocin regulation would confound the interpretation of results.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Study Officials

• Mirjam Christ-Crain, Prof. Dr. med.

  University Hospital Basel Endocrinology, Diabetes and Metabolism

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mirjam Christ-Crain, Prof. Dr. med.

CONTACT

0041612652525; Mirjam.Christ-Crain@usb.ch

Study Design

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

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: August 3, 2026
• Study Start (Estimated): June 1, 2027
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)