Menstrual CycleNCT06222749
Oxytocin and Reward Processing in Women
A study testing Intranasal oxytocin administration in people with Menstrual Cycle and Hormonal Contraception, run by International Research Training Group 2804 at 1 site in Germany.
Trial summary
Oxytocin is a hypothalamic neuropeptide that is best known for its peripheral physiological effects in the female organism i.e., uterine contractions during birth. The neuropeptide furthermore affects reward processing and metabolic functions such as eating behavior and body weight. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Cycle, Hormonal Contraception
- What is being tested?
- Intranasal oxytocin administration
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 16 Feb 2024to 31 Dec 2026
- Phase
- Interventional
- 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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body-mass index (BMI): 18-28 kg/m2
- Sex: female (since birth)
- Normal or corrected vision
- Natural menstrual cycle (NC) or intake of hormonal oral contraceptives (OC)
- NC: No hormonal contraception for at least 6 months; regular menstrual cycle (between 25 and 31 days) prior to participation
- OC: No hormonal contraception for at least 4 months, regular intake of OC pill
Who cannot join
- No German language fluency (due to German language test content)
- Smoking
- Medication taken within the last 6 weeks (except for OCs in the respective group)
- Current neurological or psychiatric disease (anamnestic survey)
- Current medical problems such as hormonal, metabolic, or chronic diseases (e.g., severe hypertension, diabetes, dysfunctions of the thyroid, or congestive heart failure)
- Pregnancy, delivery and lactation (current and within the last year; anamnestic survey, current pregnancy test)
Show all 20Show fewer
- Premenstrual dysphoric disorder (PMDD), endometriosis or polycystic ovary syndrome (PCOS)
- Shift work
- NC: Any kind of hormonal treatment or contraception
- OC: Any kind of hormonal treatment or contraception (except OCs)
- Contraindication for MRI:
- Non-removable metal objects on or in the body
- Tattoos (if MRI-incompatible according to expert guidelines)
- Pathological hearing or increased sensitivity to loud noise
- Claustrophobia
- Operation less than three months ago
- Neurological disease or injury
- Moderate or severe head injury
- Intake of antidepressants or neuroleptics
- Restricted vision
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Johannes Klaus, MD contact
Germany1 site, 1 recruiting
- Recruiting
University of Tuebingen; Department of Psychiatry & Psychotherapy; Institute of Medical Psychology and Behavioural Neurobiology
Tübingen, Baden-Wurttemberg, 72076
About this study
Official title: The Role of Oxytocin in Reward Processing Across the Menstrual Cycle and With Oral Contraceptive Use
Oxytocin is a hypothalamic neuropeptide that is best known for its peripheral physiological effects in the female organism i.e., uterine contractions during birth. The neuropeptide furthermore affects reward processing and metabolic functions such as eating behavior and body weight. Oxytocin receptors are present in brain regions associated with the processing of rewards, e.g., ventral tegmental area (VTA), nucleus accumbens (NAcc) and nucleus stria terminalis.
Previous studies indicate that oxytocin interacts with sex hormones such as estradiol in a sex-specific manner. Despite known sex differences in oxytocin function, most studies i.e., on the metabolic effects of oxytocin in humans have so far focused on young, healthy men.
Read more
Intranasal oxytocin administration has emerged as a method to experimentally investigate central nervous effects of oxytocin in the absence of relevant side effects.
In the proposed study the investigators aim to systematically investigate the acute effect of intranasal oxytocin on reward processing in relation to circulating and synthetic sex hormones in healthy, naturally cycling women and in women taking hormonal oral contraceptive pills. The investigators will administer 24 international units (IU) of intranasal oxytocin vs. placebo and investigate neural correlates in a 3T MRI scanner including functional imaging during a reward processing task, changes in brain anatomy and connectivity. Additionally, metabolic functions, eating behavior and changes in mood and wellbeing will be assessed and blood will be drawn to assess parameters of hormonal and metabolic status.
Read the detailed description
This pharmaco-neuroimaging study will investigate four groups of women: (1) naturally cycling (NC) women in the follicular phase of the menstrual cycle (n = 25), (2) NC women in the luteal phase of the menstrual cycle (n = 25), (3) women taking combined oral hormonal contraceptives (OC) (n = 25), (4) women taking progestogen-only OC (n = 25).
All participants will take part in an intake session (T0) and two experimental sessions (T1 and T2) scheduled approximately four weeks apart. In the intake session (T0) the eligibility of the participants i.e., MRI compatibility, will be verified. Additionally, the participants will be asked to fill out questionnaires i.e., regarding their personality, sleep and eating behavior and perform standardized cognitive tests.
To disentangle the influence of oxytocin on reward processing and metabolism across different hormonal status in females, intranasal oxytocin (24 IU) will be administered in one experimental session and placebo in another, in a randomized and double-blind study design. The investigators will obtain sex steroids (e.g., progesterone, estrogen, testosterone) i.e., to verify the menstrual cycle phase, synthetic steroids (e.g., ethinylestradiol, levonorgestrel) and metabolic hormones (e.g., glucose, insulin, c-peptide) from blood samples in the two experimental sessions. In the baseline phase of each experimental session (T1 and T2), the investigators will assess the participants body composition with bioimpedance analysis and resting energy expenditure with indirect calorimetry. After the intranasal administration of oxytocin or placebo, a 3 Tesla (3T) functional magnetic resonance imaging (fMRI) session will follow including the Effort Allocation Task (EAT), an effort-based decision-making task, a resting-state fMRI and diffusion tensor imaging (DTI) scan. The experimental sessions will furthermore assess the participants mood, thirst and hunger throughout the experimental period and include a snack test to assess eating related behavior. Additionally, participants will be asked to fill out questionnaires assessing i.e., sleep, emotion regulation, decision making, sexual function and wellbeing.
The investigators hypothesize that, (1) the acute effect of oxytocin on reward processing in naturally cycling women is most pronounced during the follicular phase and (2) the acute effect of oxytocin on reward processing in women is dampened by the intake of oral contraceptive pills (OCs), in particular progestogen-only pills.
- Conditions
- Menstrual Cycle, Hormonal Contraception
- Being tested
- Intranasal oxytocin administration, Intranasal placebo administration
- Keywords
- Oxytocin, Intranasal oxytocin, magnetic resonance imaging, MRI, fMRI, energy homeostasis, metabolism, reward processing, motivation, menstrual cycle, hormonal contraceptives, sex hormones, eating behavior, women's mental health
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal oxytocin administrationDrug
Also called Syntocinon
24 international units (IU) of Syntocinon, nasal spray solution; 1 ml nasal spray contains 40 I.U. oxytocin (equivalent to 67 mcg). One spray hub (0.1 ml) contains 4 I.U. oxytocin (equivalent to 6.7 mcg).
Intranasal placebo administrationDrug
Also called Placebo
Nasal spray solution; Placebo will be administered as the placebo controlled condition.
| Study group | Role | What they receive |
|---|---|---|
| NC follicular | Experimental | Naturally cycling, healthy women in the follicular menstrual cycle phase. Receives: Drug: Intranasal oxytocin administration; Drug: Intranasal placebo administration |
| NC luteal | Experimental | Naturally cycling, healthy women in the luteal menstrual cycle phase. Receives: Drug: Intranasal oxytocin administration; Drug: Intranasal placebo administration |
| OC combined | Experimental | Healthy women taking combined oral hormonal contraceptives. Receives: Drug: Intranasal oxytocin administration; Drug: Intranasal placebo administration |
| OC progestogen-only | Experimental | Healthy women taking progestogen-only oral hormonal contraceptives. Receives: Drug: Intranasal oxytocin administration; Drug: Intranasal placebo administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxytocin and sex hormone level induced changes in reward-related brain responses in the reward circuitry during effort-based decision making.
Comparing brain activity (BOLD signals) in the reward circuitry (ROIs: nucleus accumbens, putamen, caudate, ventral tegmental area, amygdala, ventromedial prefrontal cortex, orbitofrontal cortex, anterior cingulate cortex, insula) and cognitive control areas (ROIs: dorsolateral and ventromedial prefrontal cortex, anterior cingulate cortex, supplementary motor area) of female participants in luteal menstrual cycle phase, follicular menstrual cycle phase, with combined OC intake and progestogen-only OC intake during a reward task with oxytocin vs placebo.
Measured: During neuroimaging (60 minutes) oxytocin compared to placebo condition.
Oxytocin induced changes in reward related behavior.
Force exerted on grip force controller to obtain rewards and changes in behavioral parameters measured during the Effort Allocation Task after oxytocin vs. placebo administration.
Measured: During neuroimaging (60 minutes) oxytocin compared to placebo condition.
Oxytocin induced changes in eating behaviour.
Number of consumed calories (kcal) in a snack test and subjective satiety in oxytocin vs. placebo condition.
Measured: During the experimental session (approximately 4.5 hours).
Secondary outcomes (3)
Oxytocin induced changes in functional connectivity.
Functional connectivity of regions of the mesocorticolimbic circuitry (ROIs: nucleus accumbens, putamen, caudata, ventral tegmental area, amygdala, ventral medial prefrontal cortex, orbitofrontal cortex, anterior cingulate cortex) and limbic circuity (ROIs: hypothalamus, hippocampus) after oxytocin vs. placebo administration.
Measured: During neuroimaging (60 minutes) oxytocin compared to placebo condition.
Oxytocin induced changes in stress-axis reactivity.
Cortisol concentrations assessed by blood samples after oxytocin vs. placebo administration.
Measured: During the experimental session (approximately 4.5 hours).
Sex hormone induced changes in energy expenditure.
Changes in resting energy expenditure, measured by indirect calorimetry.
Measured: Measured in each experimental session, approximately 4 weeks apart; between-subject outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start16 Feb 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual CycleStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The investigators will assess the effects of oxytocin administration on reward processing and metabolism using a double-blind randomized cross-over design. In a within subject design, participants will get receive both oxytocin and placebo (both conditions) at different time points (approximately 4 weeks apart). After drug/placebo administration we will assess cerebral blood flow and functional connectivity at rest (via functional magnetic resonance imaging (fMRI)) during an effort-based decision-making task.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Research Training Group 2804
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Tuebingen, German Research Foundation, Uppsala University
- Responsible party
- Sponsor
- Investigators
- Manfred Hallschmid, Professor, Principal investigator, Institute of Medical Psychology and Behavioural Neurobiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222749
- Sponsor's protocol ID
- IRTG_P06
- Status last verified
- Jan 2024
- First submitted
- 15 Dec 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the publication of the key results of the study, all anonymized imaging data will be made publicly available (e.g., at openfmri.org).
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Oxytocin in Reward Processing Across the Menstrual Cycle and With Oral Contraceptive Use
- ClinicalTrials.gov ID
- NCT06222749
- Acronym / sponsor ID
- IRTG_P06
- Conditions
- Menstrual Cycle, Hormonal Contraception
- Keywords
- Oxytocin, Intranasal oxytocin, magnetic resonance imaging, MRI, fMRI, energy homeostasis, metabolism, reward processing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- International Research Training Group 2804University, hospital or other
- Collaborators
- University Hospital Tuebingen, German Research Foundation, Uppsala University
- Study start
- 16 Feb 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Jan 2024 (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.
Oxytocin is a hypothalamic neuropeptide that is best known for its peripheral physiological effects in the female organism i.e., uterine contractions during birth. The neuropeptide furthermore affects reward processing and metabolic functions such as eating behavior and body weight. Oxytocin receptors are present in brain regions associated with the processing of rewards, e.g., ventral tegmental area (VTA), nucleus accumbens (NAcc) and nucleus stria terminalis.
Previous studies indicate that oxytocin interacts with sex hormones such as estradiol in a sex-specific manner. Despite known sex differences in oxytocin function, most studies i.e., on the metabolic effects of oxytocin in humans have so far focused on young, healthy men.
Intranasal oxytocin administration has emerged as a method to experimentally investigate central nervous effects of oxytocin in the absence of relevant side effects.
In the proposed study the investigators aim to systematically investigate the acute effect of intranasal oxytocin on reward processing in relation to circulating and synthetic sex hormones in healthy, naturally cycling women and in women taking hormonal oral contraceptive pills. The investigators will administer 24 international units (IU) of intranasal oxytocin vs. placebo and investigate neural correlates in a 3T MRI scanner including functional imaging during a reward processing task, changes in brain anatomy and connectivity. Additionally, metabolic functions, eating behavior and changes in mood and wellbeing will be assessed and blood will be drawn to assess parameters of hormonal and metabolic status.
Detailed description
This pharmaco-neuroimaging study will investigate four groups of women: (1) naturally cycling (NC) women in the follicular phase of the menstrual cycle (n = 25), (2) NC women in the luteal phase of the menstrual cycle (n = 25), (3) women taking combined oral hormonal contraceptives (OC) (n = 25), (4) women taking progestogen-only OC (n = 25).
All participants will take part in an intake session (T0) and two experimental sessions (T1 and T2) scheduled approximately four weeks apart. In the intake session (T0) the eligibility of the participants i.e., MRI compatibility, will be verified. Additionally, the participants will be asked to fill out questionnaires i.e., regarding their personality, sleep and eating behavior and perform standardized cognitive tests.
To disentangle the influence of oxytocin on reward processing and metabolism across different hormonal status in females, intranasal oxytocin (24 IU) will be administered in one experimental session and placebo in another, in a randomized and double-blind study design. The investigators will obtain sex steroids (e.g., progesterone, estrogen, testosterone) i.e., to verify the menstrual cycle phase, synthetic steroids (e.g., ethinylestradiol, levonorgestrel) and metabolic hormones (e.g., glucose, insulin, c-peptide) from blood samples in the two experimental sessions. In the baseline phase of each experimental session (T1 and T2), the investigators will assess the participants body composition with bioimpedance analysis and resting energy expenditure with indirect calorimetry. After the intranasal administration of oxytocin or placebo, a 3 Tesla (3T) functional magnetic resonance imaging (fMRI) session will follow including the Effort Allocation Task (EAT), an effort-based decision-making task, a resting-state fMRI and diffusion tensor imaging (DTI) scan. The experimental sessions will furthermore assess the participants mood, thirst and hunger throughout the experimental period and include a snack test to assess eating related behavior. Additionally, participants will be asked to fill out questionnaires assessing i.e., sleep, emotion regulation, decision making, sexual function and wellbeing.
The investigators hypothesize that, (1) the acute effect of oxytocin on reward processing in naturally cycling women is most pronounced during the follicular phase and (2) the acute effect of oxytocin on reward processing in women is dampened by the intake of oral contraceptive pills (OCs), in particular progestogen-only pills.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- The investigators will assess the effects of oxytocin administration on reward processing and metabolism using a double-blind randomized cross-over design. In a within subject design, participants will get receive both oxytocin and placebo (both conditions) at different time points (approximately 4 weeks apart). After drug/placebo administration we will assess cerebral blood flow and functional connectivity at rest (via functional magnetic resonance imaging (fMRI)) during an effort-based decision-making task.
| Arm | Type | Receives |
|---|---|---|
| NC follicular | Experimental | Drug: Intranasal oxytocin administration, Drug: Intranasal placebo administrationNaturally cycling, healthy women in the follicular menstrual cycle phase. |
| NC luteal | Experimental | Drug: Intranasal oxytocin administration, Drug: Intranasal placebo administrationNaturally cycling, healthy women in the luteal menstrual cycle phase. |
| OC combined | Experimental | Drug: Intranasal oxytocin administration, Drug: Intranasal placebo administrationHealthy women taking combined oral hormonal contraceptives. |
| OC progestogen-only | Experimental | Drug: Intranasal oxytocin administration, Drug: Intranasal placebo administrationHealthy women taking progestogen-only oral hormonal contraceptives. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Body-mass index (BMI): 18-28 kg/m2
- Sex: female (since birth)
- Normal or corrected vision
- Natural menstrual cycle (NC) or intake of hormonal oral contraceptives (OC)
- NC: No hormonal contraception for at least 6 months; regular menstrual cycle (between 25 and 31 days) prior to participation
Key exclusion criteria (20 listed)
- No German language fluency (due to German language test content)
- Smoking
- Medication taken within the last 6 weeks (except for OCs in the respective group)
- Current neurological or psychiatric disease (anamnestic survey)
- Current medical problems such as hormonal, metabolic, or chronic diseases (e.g., severe hypertension, diabetes, dysfunctions of the thyroid, or congestive heart failure)
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 |
|---|---|---|
| Intranasal oxytocin administrationAlso: Syntocinon24 international units (IU) of Syntocinon, nasal spray solution; 1 ml nasal spray contains 40 I.U. oxytocin (equivalent to 67 mcg). One spray hub (0.1 ml) contains 4 I.U. oxytocin (equivalent to 6.7 mcg). | Drug | NC follicular, NC luteal, OC combined, OC progestogen-only |
| Intranasal placebo administrationAlso: PlaceboNasal spray solution; Placebo will be administered as the placebo controlled condition. | Drug | NC follicular, NC luteal, OC combined, OC progestogen-only |
Primary outcome
Oxytocin and sex hormone level induced changes in reward-related brain responses in the reward circuitry during effort-based decision making.
Time frame: During neuroimaging (60 minutes) oxytocin compared to placebo condition.
Comparing brain activity (BOLD signals) in the reward circuitry (ROIs: nucleus accumbens, putamen, caudate, ventral tegmental area, amygdala, ventromedial prefrontal cortex, orbitofrontal cortex, anterior cingulate cortex, insula) and cognitive control areas (ROIs: dorsolateral and ventromedial prefrontal cortex, anterior cingulate cortex, supplementary motor area) of female participants in luteal menstrual cycle phase, follicular menstrual cycle phase, with combined OC intake and progestogen-only OC intake during a reward task with oxytocin vs placebo.
Oxytocin induced changes in reward related behavior.
Time frame: During neuroimaging (60 minutes) oxytocin compared to placebo condition.
Force exerted on grip force controller to obtain rewards and changes in behavioral parameters measured during the Effort Allocation Task after oxytocin vs. placebo administration.
Oxytocin induced changes in eating behaviour.
Time frame: During the experimental session (approximately 4.5 hours).
Number of consumed calories (kcal) in a snack test and subjective satiety in oxytocin vs. placebo condition.
3 secondary outcomes
Oxytocin induced changes in functional connectivity.
Time frame: During neuroimaging (60 minutes) oxytocin compared to placebo condition.
Oxytocin induced changes in stress-axis reactivity.
Time frame: During the experimental session (approximately 4.5 hours).
Sex hormone induced changes in energy expenditure.
Time frame: Measured in each experimental session, approximately 4 weeks apart; between-subject outcome
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 28 Feb 2024.
- Individual participant dataSharing planned: Yes. After the publication of the key results of the study, all anonymized imaging data will be made publicly available (e.g., at openfmri.org).
Related trials for Menstrual Cycle
RecruitingPhase 2
A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Functional Hypothalamic Amenorrhea, FHA
RecruitingObservational study
Body Clocks - Coordination of Peripheral and Central Oscillators
Circadian Dysregulation
Not yet recruitingObservational study
FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women
Alcohol Use, Alcohol Consumption
Active, not recruitingObservational study
Factors Influencing Fertility or Pregnancy Health
Menstrual Cycles, Conception
Recruiting
Delivering tAN to Reduce HMB: The LUNA Study
Heavy Menstrual Bleeding
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.
Johannes Klaus, MD contact
Manfred Hallschmid, Professor principal investigator
Institute of Medical Psychology and Behavioural Neurobiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intranasal oxytocin administration in people with Menstrual Cycle and Hormonal Contraception, run by International Research Training Group 2804 at 1 site in Germany.
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 20 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 28 Feb 2024. 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 Germany. 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 Manfred Hallschmid, Professor (+49 7071 29 88925, manfred.hallschmid@uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxytocin and sex hormone level induced changes in reward-related brain responses in the reward circuitry during effort-based decision making. (time frame: During neuroimaging (60 minutes) oxytocin compared to placebo condition.). The study lists 3 primary outcomes in all. 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 28 Feb 2024.