ProlactinNCT05208684
Prolactin Release Through Breast Stimulation in Non-lactating Women - Who Does Respond?
A study testing Breast stimulation in people with Prolactin and Breast Stimulation, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Prolactin is a multifunctional hormone which acts in different cell types rather than just modulating reproduction and lactation. One additional point is its action on glucose metabolism which is described especially in rodents. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prolactin, Breast Stimulation
- What is being tested?
- Breast stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 21 Feb 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women, aged between 18 and 45 years
- premenopausal (women, who had menses at any time in the preceding 24 consecutive months)
- BMI < 25 kg/m²
- Ability to understand and voluntarily sign an informed consent document prior to any study related procedures
Who cannot join
- Type 1 or Type 2 diabetes
- Intake of medication which may affect prolactin levels (e.g. Metoclopramide, Methyldopa, opiates, cimetidine), except birth control pill/hormonal contraception known hyperprolactinemia or hyperthyroidism
- any other serious illness that might impact the results as judged by the investigator (e.g. malignant disease, coronary heart disease)
- Pregnant / breastfeeding women (weaning at least 6 month ago)
- plastic breast surgery (with detachment of milk ducts)
- allergy to BPA-free plastic
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Tuebingen, Otfried-Mueller Str. 10
Tübingen, 72076
Louise Fritsche, Dr., +49 (0)7071 29 80687, louise.fritsche@med.uni-tuebingen.de
About this study
Prolactin is a multifunctional hormone which acts in different cell types rather than just modulating reproduction and lactation. One additional point is its action on glucose metabolism which is described especially in rodents. Prolactin affects proliferation, survival and insulin production of pancreatic beta cells in animal models. But also in human studies prolactin is linked to insulin action. Low systemic levels of prolactin are associated with increased prevalence of diabetes and while higher levels are associated with higher insulin sensitivity.
Acute metabolic effects of prolactin in young, healthy and non-lactating women should be accessed. Therefore, the induction of a transient increase of circulating prolactin levels is necessary to study the acute effects of this hormone on metabolic processes. This can most likely be achieved in non-pregnant and non-lactating women without pharmacological intervention.
Read more
As the main stimulus of prolactin release from the pituitary gland is the mechanical stimulation of the breast / nipple, like a suckling baby, stimulation by a breast pump might trigger prolactin release.
Due to other studies in this field, only a minority of women respond to breast stimulation with an increase in prolactin levels. Therefore, this pilot study will assess if an electric milk pump can stimulate prolactin release in non-lactating women. The second aim of the study is to identify factors which determine response and non-response to breast stimulation.
Prolactin will be measured in blood serum. The primary objective of this study is to identify women in whom a 30-minute breast stimulation causes a marked prolactin release. Response is defined as an increase at least twice the baseline value.
Second outcomes are the quantification and duration of prolactin increase as well as to detect differences in responders and non-responders. Therefore, demographic data as well as anthropometric data will also be assessed. A 10-minute electrocardiography and non-invasive measurement of resting energy expenditure by indirect calorimetry will also be performed. History of menstrual cycle, intake of contraceptive, parity and lactation experience will be recorded. Physical activity level and feeling of hunger will be assessed by questionnaires.
Feeling of hunger, resting energy expenditure, blood pressure, heart rate and body temperature will be assessed repeatedly to register differences before and after stimulation. Blood and urine samples will be assessed for safety.
- Conditions
- Prolactin, Breast Stimulation
- Being tested
- Breast stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast stimulationOther
Breast stimulation by the Elvie Pump to trigger prolactin release.
| Study group | Role | What they receive |
|---|---|---|
| Breast stimulation | Experimental | A 30-minute stimulation with moderate intensity by an electric milk pump (Elvie Pump) will be performed. Receives: Other: Breast stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolactin release - yes/no
The primary objective of this study is to identify women in whom breast stimulation causes a marked prolactin release. Response is defined as an increase at least twice the baseline blood value.
Measured: Sample collection will be from 0 to 90 minutes
Secondary outcomes (25)
Prolactin levels
Quantification, duration and trajectory of prolactin increase will be assessed by measuring prolactin levels in blood
Measured: Sample collection will be from 0 to 90 minutes
Differences in subjects age
Differences between responders and non-responders will be assessed: differences in age by recording birth date
Measured: 1 minute
Differences in subjects BMI
Differences between responders and non-responders will be assessed: differences in Body Mass Index by measuring height and weight of subjects and calculate the BMI
Measured: 4 minutes
Differences in subjects body fat content
Differences between responders and non-responders will be assessed: differences in body fat content by bioelectrical impedance analysis
Measured: 3 minutes
Differences in subjects menstrual cycle phase
Differences between responders and non-responders will be assessed: differences in phase of menstrual cycle by recording the menstrual history
Measured: 2 minutes
Differences in subjects intake of hormonal contraception
Differences between responders and non-responders will be assessed: differences in intake of hormonal contraception recording intake of medication
Measured: 2 minutes
Differences in subjects parity
Differences between responders and non-responders will be assessed: differences in parity by recording family history
Measured: 2 minutes
Differences in subjects history of lactation
Differences between responders and non-responders will be assessed: differences in history of lactation experience by recording history of lactation
Measured: 2 minutes
Differences in subjects heart rate variability parameters: time domain (beats per minute)
Differences between responders and non-responders and within subjects will be assessed: differences in the time domain by two 10-minute 3 lead ECG measurements before and after stimulation
Measured: 10 minutes
Differences in subjects heart rate variability parameters: Root Mean Square of successive RR interval differences (RMSSD)
Differences between responders and non-responders and within subjects will be assessed: differences in RMSSD by two 10-minute 3 lead ECG measurements before and after stimulation
Measured: 10 minutes
Differences in subjects heart rate variability parameters: Standard deviation of RR-intervals (SDNN)
Differences between responders and non-responders and within subjects will be assessed: differences SDNN by two 10-minute 3 lead ECG measurements before and after stimulation
Measured: 10 minutes
Differences in subjects heart rate variability parameters: frequency domain parameters
Differences between responders and non-responders and within subjects will be assessed: differences in low (LF) and high (HF) frequency power by two 10-minute 3 lead ECG measurements before and after stimulation
Measured: 10 minutes
Differences in subjects heart rate variability parameters: Low to high frequency power ratio
Differences between responders and non-responders and within subjects will be assessed: differences in LF/HF - Ratio by two 10-minute 3 lead ECG measurements before and after stimulation
Measured: 20 minutes
Differences in subjects physical activity level
Differences between responders and non-responders will be assessed: differences physical activity level by questionnaire including the baecke index
Measured: 10 minutes
Differences in subjects stress reaction
Differences between responders and non-responders will be assessed: differences in stress, measured by cortisol levels in blood
Measured: Sample collection will be from 0 to 90 minutes
Changes in feelings of hunger through stimulation
Register change of feeling of hunger before and after stimulation by 15 questions on a five-point Likert scale survey about food cravings (FCQ-S)
Measured: 10 minutes
Changes in resting energy expenditure through stimulation
Register change of resting energy expenditure before and after stimulation by indirect calorimetry
Measured: 30 minutes (each 15 minutes)
Changes in blood pressure through stimulation
Register changes in blood pressure before and after stimulation using an automatic instrument with a digital readout
Measured: 4 minutes
Changes in heart rate through stimulation
Register changes in heart rate before and after stimulation using an automatic instrument with a digital readout
Measured: 4 minutes
Changes in body temperature through stimulation
Register changes of body temperature before and after stimulation by an ear thermometer
Measured: 1 minute
Changes of Hypothalamic-Pituitary-Adrenal axis activity
Changes in Corticotropin levels are assessed by measurement in blood
Measured: 90 minutes
Changes of Hypothalamic-Pituitary-Somatotropic axis activity
Changes in Somatotropin and insulin-like growth factor 1 levels are assessed by measurement in blood
Measured: 90 minutes
Changes of Hypothalamic-Pituitary-Prolactin axis activity
Changes in Prolactin levels are assessed by measurement in blood
Measured: 90 minutes
Changes of Hypothalamic-Pituitary-Thyroid axis activity
Changes in levels of Thyroid-stimulating hormone, Triiodthyronine and Thyroxine are assessed by measurement in blood
Measured: 90 minutes
Changes of Hypothalamic-Pituitary-Gonadal axis activity
Changes in levels of Follicle stimulating hormone, Luteinizing hormone, estradiol and progesterone are assessed by measurement in blood
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start21 Feb 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProlactinStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05208684
- Sponsor's protocol ID
- PRL Pilot
- Status last verified
- May 2024
- First submitted
- 8 Dec 2021
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolactin Release Through Breast Stimulation in Non-lactating Women - Who Does Respond?
- ClinicalTrials.gov ID
- NCT05208684
- Acronym / sponsor ID
- PRL Pilot
- Conditions
- Prolactin, Breast Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 26 Jan 2022 (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.
Prolactin is a multifunctional hormone which acts in different cell types rather than just modulating reproduction and lactation. One additional point is its action on glucose metabolism which is described especially in rodents. Prolactin affects proliferation, survival and insulin production of pancreatic beta cells in animal models. But also in human studies prolactin is linked to insulin action. Low systemic levels of prolactin are associated with increased prevalence of diabetes and while higher levels are associated with higher insulin sensitivity.
Acute metabolic effects of prolactin in young, healthy and non-lactating women should be accessed. Therefore, the induction of a transient increase of circulating prolactin levels is necessary to study the acute effects of this hormone on metabolic processes. This can most likely be achieved in non-pregnant and non-lactating women without pharmacological intervention.
As the main stimulus of prolactin release from the pituitary gland is the mechanical stimulation of the breast / nipple, like a suckling baby, stimulation by a breast pump might trigger prolactin release.
Due to other studies in this field, only a minority of women respond to breast stimulation with an increase in prolactin levels. Therefore, this pilot study will assess if an electric milk pump can stimulate prolactin release in non-lactating women. The second aim of the study is to identify factors which determine response and non-response to breast stimulation.
Prolactin will be measured in blood serum. The primary objective of this study is to identify women in whom a 30-minute breast stimulation causes a marked prolactin release. Response is defined as an increase at least twice the baseline value.
Second outcomes are the quantification and duration of prolactin increase as well as to detect differences in responders and non-responders. Therefore, demographic data as well as anthropometric data will also be assessed. A 10-minute electrocardiography and non-invasive measurement of resting energy expenditure by indirect calorimetry will also be performed. History of menstrual cycle, intake of contraceptive, parity and lactation experience will be recorded. Physical activity level and feeling of hunger will be assessed by questionnaires.
Feeling of hunger, resting energy expenditure, blood pressure, heart rate and body temperature will be assessed repeatedly to register differences before and after stimulation. Blood and urine samples will be assessed for safety.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast stimulation | Experimental | Other: Breast stimulationA 30-minute stimulation with moderate intensity by an electric milk pump (Elvie Pump) will be performed. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women, aged between 18 and 45 years
- premenopausal (women, who had menses at any time in the preceding 24 consecutive months)
- BMI < 25 kg/m²
- Ability to understand and voluntarily sign an informed consent document prior to any study related procedures
Key exclusion criteria (6 listed)
- Type 1 or Type 2 diabetes
- Intake of medication which may affect prolactin levels (e.g. Metoclopramide, Methyldopa, opiates, cimetidine), except birth control pill/hormonal contraception known hyperprolactinemia or hyperthyroidism
- any other serious illness that might impact the results as judged by the investigator (e.g. malignant disease, coronary heart disease)
- Pregnant / breastfeeding women (weaning at least 6 month ago)
- plastic breast surgery (with detachment of milk ducts)
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 |
|---|---|---|
| Breast stimulationBreast stimulation by the Elvie Pump to trigger prolactin release. | Other | Breast stimulation |
Primary outcome
Prolactin release - yes/no
Time frame: Sample collection will be from 0 to 90 minutes
The primary objective of this study is to identify women in whom breast stimulation causes a marked prolactin release. Response is defined as an increase at least twice the baseline blood value.
25 secondary outcomes
Prolactin levels
Time frame: Sample collection will be from 0 to 90 minutes
Differences in subjects age
Time frame: 1 minute
Differences in subjects BMI
Time frame: 4 minutes
Differences in subjects body fat content
Time frame: 3 minutes
Differences in subjects menstrual cycle phase
Time frame: 2 minutes
Differences in subjects intake of hormonal contraception
Time frame: 2 minutes
Differences in subjects parity
Time frame: 2 minutes
Differences in subjects history of lactation
Time frame: 2 minutes
Differences in subjects heart rate variability parameters: time domain (beats per minute)
Time frame: 10 minutes
Differences in subjects heart rate variability parameters: Root Mean Square of successive RR interval differences (RMSSD)
Time frame: 10 minutes
Differences in subjects heart rate variability parameters: Standard deviation of RR-intervals (SDNN)
Time frame: 10 minutes
Differences in subjects heart rate variability parameters: frequency domain parameters
Time frame: 10 minutes
Differences in subjects heart rate variability parameters: Low to high frequency power ratio
Time frame: 20 minutes
Differences in subjects physical activity level
Time frame: 10 minutes
Differences in subjects stress reaction
Time frame: Sample collection will be from 0 to 90 minutes
Changes in feelings of hunger through stimulation
Time frame: 10 minutes
Changes in resting energy expenditure through stimulation
Time frame: 30 minutes (each 15 minutes)
Changes in blood pressure through stimulation
Time frame: 4 minutes
Changes in heart rate through stimulation
Time frame: 4 minutes
Changes in body temperature through stimulation
Time frame: 1 minute
Changes of Hypothalamic-Pituitary-Adrenal axis activity
Time frame: 90 minutes
Changes of Hypothalamic-Pituitary-Somatotropic axis activity
Time frame: 90 minutes
Changes of Hypothalamic-Pituitary-Prolactin axis activity
Time frame: 90 minutes
Changes of Hypothalamic-Pituitary-Thyroid axis activity
Time frame: 90 minutes
Changes of Hypothalamic-Pituitary-Gonadal axis activity
Time frame: 90 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
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Active, not recruitingObservational study
CASE 1320: RAI Uptake and Serum Prolactin in Thyroid Cancer
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast stimulation in people with Prolactin and Breast Stimulation, run by University Hospital Tuebingen 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 14 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Louise Fritsche, Dr.rer.nat. (+4970712780687, louise.fritsche@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prolactin release - yes/no (time frame: Sample collection will be from 0 to 90 minutes). 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 14 May 2024.