PostmenopausalOxyMENONCT07742124
Oxytocin in Postmenopausal Women
An observational study of Postmenopausal and Premenopausal, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postmenopausal, Premenopausal
- What is being tested?
- Repeated assessments
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Aug 2026to 1 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel
Basel, Canton of Basel-City, 4031
Mirjam Christ-Crain, Prof. Dr. med., +41 61 265 25 25, mirjam.christ-crain@usb.ch
About this study
Official title: Circulating Oxytocin and Its Clinical Correlates in Postmenopausal Women Compared With Premenopausal Controls - The OxyMENO Study
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.
Read the 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
- Conditions
- Postmenopausal, Premenopausal
- Being tested
- Repeated assessments
- Keywords
- Oxytocin, Postmenopausal, Premenopausal, Neurophysin-I, cyclic hormonal condition, menstrual cyclic phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repeated assessmentsOther
This study is an observational investigation involving repeated venous blood sampling and non-invasive clinical assessments ov four study visits.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Repeated assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Secondary outcomes (33)
Cycle-phase-specific OXT/NP-I concentrations
Phase-specific plasma OXT/NP-I concentrations at each study visit
Measured: 1 month
Gonadal Hormone concentrations
Estradiol for confirmation of cycle phase and assessment of hormonal correlates
Measured: 1 month
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.
Measured: 1 month
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).
Measured: 1 month
Psychological and affective measure - sleep quality
Sleep quality over one month assessed by a validated questionnaire (Pittsburgh Sleep Quality Index) after a sleep counselling session (session at baseline visit). The Pittsburgh Sleep Quality Index ranges from 0 to 21, with higher scores indicating greater sleep difficulties.
Measured: 1 month
Climacteric symptoms
Climacteric symptoms, assessed by a validated questionnaire (Menopause rating scale (MRS)). MRS is an 11-item self-assessment tool designed to measure symptom severity and quality of life in aging women. The total MRS score ranges from 0 to 44 points, with higher scores indicating more severe symptoms and a poorer outcome.
Measured: 1 month
Emotion recognition performance
Emotion recognition performance (accuracy and reaction time), assessed by a computerized facial emotion recognition task (Facial Emotion Recognition Test)
Measured: 1 month
Empathy
Empathy, assessed by validated questionnaire-based measures (Empathy Quotient). The Empathy Quotient (EQ) test is a 60-item questionnaire intended to measure levels of empathy in adults. The total EQ score ranges from 0 to 80 points, with higher scores indicating greater empathy and a better outcome.
Measured: 1 month
Socio-affective processing
Socio-affective processing, assessed by validated questionnaire-based measures (Toronto Alexithymia Scale-20). The scale was designed to assess the three factors: (a) difficulty identifying feelings (DIF), (b) difficulty describing feelings (DDF), and (c) external-oriented thinking (EOT). The TAS-20 score measures alexithymia on a scale from 20 to 100 with higher scores indicating greater levels of alexithymia and a poorer outcome.
Measured: 1 month
Stress reactivity - subjective stress rating
Subjective stress ratings, assessed using a Numerical Rating Scale (NRS). Subjective stress reflects an individual's self-reported psychological and emotional distress. Fear will be assessed on an NRS ranging from 0 (no fear) to 10 (extreme fear/panic), with higher scores indicating greater perceived fear.
Measured: 1 month
Stress reactivity - autonomic measures
Stress reactivity is assessed using a standardized social stress test, including autonomic measures (heart rate and blood pressure)
Measured: 1 month
Stress reactivity - endocrine stress markers
Assessed using a standardized social stress test, including endocrine stress markers (e.g. salivary or plasma cortisol)
Measured: 1 month
Cardiometabolic parameter
Body mass index
Measured: 1 month
Cardiometabolic parameter
Blood pressure
Measured: 1 month
Cardiometabolic parameters
Fasting glucose (± insulin/Homeostatic Model Assessment for Insulin Resistance)
Measured: 1 month
Cardiometabolic parameter
Lipid profile (total cholesterol)
Measured: 1 month
Body composition measure
Fat mass
Measured: 1 month
Bone health parameter
Bone turnover markers (e.g., N-terminal propeptide of type I collagen)
Measured: 1 month
Bone health parameter
Calcium-phosphate metabolism (e.g. 25-hydroxyvitamin D (Vitamin-D))
Measured: 1 month
Food intake and eating behavior
Subjective craving, quantified by ratings (Numerical Rating scale 0-10) on two days during the menstrual and ovulation phase
Measured: 1 month
Food intake and eating behavior
Eating behavior (type of food, amount of food, frequency of food intake, meal structure) assessed by the eating protocol on one day during the menstrual and ovulation phases
Measured: 1 month
Gonadal hormone concentrations
Progesterone for confirmation of cycle phase and assessment of hormonal correlates
Measured: 1 month
Gonodal Hormone concentrations
Luteinizing Hormone for confirmation of cycle phase and assessment of hormonal correlates
Measured: 1 month
Gonodal Hormone concentration
Follicle Stimulating hormone for confirmation of cycle phase and assessment of hormonal correlates.
Measured: 1 month
Cardiometabolic parameter
Waist circumference
Measured: 1 month
Cardiometabolic parameter
Heart rate
Measured: 1 month
Cardiometabolic parameter
Lipid profile (low-density lipoprotein)
Measured: 1 month
Cardiometabolic parameter
Lipid profile (high-density lipoprotein)
Measured: 1 month
Cardiometabolic parameter
Lipid profile (triglycerides)
Measured: 1 month
Body composition measure
Lean mass (bioimpedance)
Measured: 1 month
Bone health parameter
Bone turnover markers (e.g., C-terminal telopeptide ± osteocalcin)
Measured: 1 month
Bone health parameter
Calcium-phosphate metabolism (e.g. Parathyroid Hormone)
Measured: 1 month
Oxytocin over Neurophysin-I secretion profile
Temporal Oxytocin over Neurophysin-1 secretion profile including group and time interaction and intra-individual variability across four visits.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start20 Aug 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostmenopausalStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mirjam Christ-Crain, Prof. Dr. med., Principal investigator, University Hospital Basel Endocrinology, Diabetes and Metabolism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742124
- Sponsor's protocol ID
- 2026-01136 - kt26ChristCrain4
- Acronym
- OxyMENO
- Status last verified
- Aug 2026
- First submitted
- 17 Jul 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Oxytocin and Its Clinical Correlates in Postmenopausal Women Compared With Premenopausal Controls - The OxyMENO Study
- ClinicalTrials.gov ID
- NCT07742124
- Acronym / sponsor ID
- OxyMENO / 2026-01136 - kt26ChristCrain4
- Conditions
- Postmenopausal, Premenopausal
- Keywords
- Oxytocin, Postmenopausal, Premenopausal, Neurophysin-I, cyclic hormonal condition, menstrual cyclic phase
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 20 Aug 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postmenopausal | – | Other: Repeated assessmentsPostmenopausal women, visits will take place during the menstrual phase, mid-follicular phase, ovulation, and mid-luteal phase, with a scheduling tolerance of ± 2days. |
| Premenopausal | – | Other: Repeated assessmentsPremenopausal women, visits will take place during the menstrual phase, mid-follicular phase, ovulation, and mid-luteal phase, with a scheduling tolerance of ± 2days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Female sex at birth
- Age ≥18 years
- Premenopausal women aged 18-35 years with regular menstrual cycles (21-35 days) for ≥3 months prior to study entry
- Postmenopausal women ≥2 years of postmenopause (i.e. 3 years since last menstrual period (LMP), with menopause defined as ≥ 12 months of amenorrhea)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repeated assessmentsThis study is an observational investigation involving repeated venous blood sampling and non-invasive clinical assessments ov four study visits. | Other | Postmenopausal, Premenopausal |
Primary outcome
Area under the curve of Neurophysin-1 (NP-I)
Time frame: 1 month
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
33 secondary outcomes
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
Cardiometabolic parameter
Time frame: 1 month
Cardiometabolic parameter
Time frame: 1 month
Cardiometabolic parameters
Time frame: 1 month
Cardiometabolic parameter
Time frame: 1 month
Body composition measure
Time frame: 1 month
Bone health parameter
Time frame: 1 month
Bone health parameter
Time frame: 1 month
Food intake and eating behavior
Time frame: 1 month
Food intake and eating behavior
Time frame: 1 month
Gonadal hormone concentrations
Time frame: 1 month
Gonodal Hormone concentrations
Time frame: 1 month
Gonodal Hormone concentration
Time frame: 1 month
Cardiometabolic parameter
Time frame: 1 month
Cardiometabolic parameter
Time frame: 1 month
Cardiometabolic parameter
Time frame: 1 month
Cardiometabolic parameter
Time frame: 1 month
Cardiometabolic parameter
Time frame: 1 month
Body composition measure
Time frame: 1 month
Bone health parameter
Time frame: 1 month
Bone health parameter
Time frame: 1 month
Oxytocin over Neurophysin-I secretion profile
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mirjam Christ-Crain, Prof. Dr. med. principal investigator
University Hospital Basel Endocrinology, Diabetes and Metabolism
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postmenopausal and Premenopausal, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mirjam Christ-Crain, Prof. Dr. med. (0041612652525, Mirjam.Christ-Crain@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve of Neurophysin-1 (NP-I) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.