MenopausePhase 4P4&REENCT04140968
Progesterone and Resting Energy Expenditure
A Phase 4 study testing Utrogestan in people with Menopause and Progesterone, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
This study evaluates the effect of micronized progesterone substitution in the luteal phase on resting energy expenditure in women during menopausal transition. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Progesterone, Weight Gain
- What is being tested?
- Utrogestan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2019to 27 May 2021
- Phase
- Phase 4
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women during early menopausal transition (MT) with indication for luteal phase progesterone substitution (definition of early MT: change of cycle length (shorter or longer menstrual cycle) of at least ≥ 7 days from normal and/or phases of amenorrhea of up to < 60 days during the preceding 12 months)
- Body Mass Index (BMI) 18.5 - 24.9 kg/m2
- Informed Consent as documented by signature
Who cannot join
- Pregnancy or Lactation
- Systemic hormone therapy or hormonal contraception (estradiol, progestogen, androgen) during the study and within 12 weeks prior to study entry
- Phytotherapeutics for menstrual cycle regulation during the study and within 12 weeks prior to study entry
- Active psychiatric disease
- Use of psychotropic drugs during the study and within 12 weeks prior to study entry
- Nicotin abuse > 10 cigarettes/day
Show all 17Show fewer
- Alcohol abuse
- Use of appetite suppressants
- Diabetes mellitus
- Untreated Hypo- and hyperthyroidism
- Hypersensitivity to progesterone
- Hypersensitivity to sunflower oil, soy lecithin and other ingredients of Utrogestan® such as gelatine, glycerol, E171 (titanium dioxide)
- Contraindication of progesterone medication according to swissmedicinfo.ch (suspected or diagnosed neoplasia of the breast or other sexual organ; benign or malignant liver Tumors (also in medical history); acute or chronic liver disease (Rotor- or Dubin-Johnson-Syndrome); cholestatic jaundice; porphyria; arterial or venous thromboembolic Events and cerebral bleedings; abnormal genital bleeding of unknown cause)
- Use of barbiturates, antiepileptic drugs, tuberculostatic drugs, antiretroviral drugs, antimycotic drugs, antibiotic drugs, Hypericum perforatum and Spironolactone
- Known or suspected non-compliance, drug or alcohol abuse etc.
- Illiteracy
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dep. of Obstetrics and Gynecology, Bern University Hospital, Bern
Bern, 3010
About this study
Official title: Impact of Progesterone Substitution in Luteal Phase on Resting Energy Expenditure in Women During Menopausal Transition.
This study evaluates the effect of micronized progesterone substitution in the luteal phase on resting energy expenditure in women during menopausal transition.
Read the detailed description
The majority of women report an increase of body weight of about 0.5 kg/year during the menopausal transition. However, the weight gain has not been attributed to menopause itself but rather to, e.g., a decrease of the basal metabolic rate due to aging, less energy expenditure and a non-adapted caloric intake.
One of the first signs of the menopausal transition is a change in the bleeding pattern due to a disruption of the hypothalamus-pituitary-ovary-axis. The number of cycles with an insufficient luteal phase and anovulatory cycles with an insufficient or even absent luteal phase increase as the menopausal transition proceeds. Thus, in perimenopausal women progesterone endogenous exposure decreases in quantity and duration. By substituting progesterone during the luteal phase, irregular cycle and bleeding patterns can be normalized. However, besides the beneficial effects of progesterone on the course of a menstrual cycle it displays some features that may be preventive for weight gain.
In this study only women in their early menopausal transition with menstrual cycle irregularities are included. By substituting progesterone during luteal phase the investigator tries to normalize their menstrual cycle pattern. The hypothesis is, that progesterone might not only normalize the menstrual cycle pattern of women in their early menopausal transition but due to its metabolic activities, progesterone may also increase the resting energy expenditure and thus may prevent weight gain during the menopausal transition. Furthermore the effect of progesterone substitution on the expression of miRNAs which are included in glucose- and lipid-metabolism such as miR-370 and miR-29 will be investigated.
- Conditions
- Menopause, Progesterone, Weight Gain
- Being tested
- Utrogestan
- Keywords
- Resting energy expenditure
- Medical subject headings
- Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UtrogestanDrug
300mg Utrogestan (1 tablet 100mg + 1 tablet 200mg) in the second and third menstrual cycle daily from cycle day 15 to 26.
| Study group | Role | What they receive |
|---|---|---|
| Utrogestan | Experimental | 300mg Utrogestan (1 tablet 100mg + 1 tablet 200mg)by mouth,every day in the second and third menstrual cycle daily from cycle day 15 to 26. Receives: Drug: Utrogestan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in resting energy expenditure
Change in resting energy expenditure (kcal/day) from cycle 1 due to substitution of Utrogestan in luteal phase
Measured: cycle 1 (day 20) to cycle 3 (day 20), (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days)
Secondary outcomes (13)
Mean change in miRNA expression
Change in miRNA expression (miR-370, miR-29b)
Measured: cycle 1 (day 5; day 20) and cycle 3 (day 5; day 20), (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days)
Mean change in energy intake
Change in energy intake (kcal/day)
Measured: cycle 1 (day 17-19) and cycle 3 (day 17-19), (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days)
Mean change in body core temperature
Change in body core temperature (°C)
Measured: cycle 1-3 during luteal phase, (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days)
Mean change in serum hormone profile FSH
Change in serum hormone profile: FSH (U/l)
Measured: cycle 1 (day 5; day 20) and cycle 3 (day 5; day 20), (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days)
Mean change in serum hormone profile LH
Change in serum hormone profile: LH (U/l)
Measured: cycle 1 (day 5; day 20) and cycle 3 (day 5; day 20), (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days)
Mean change in serum hormone profile estradiol
Change in serum hormone profile: estradiol (pmol/l)
Measured: cycle 1 (day 5; day 20) and cycle 3 (day 5; day 20)
Mean change in serum hormone profile progesterone
Change in serum hormone profile: progesterone (nmol/l)
Measured: cycle 1 (day 5; day 20) and cycle 3 (day 5; day 20), (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days)
Mean change in fasting glucose
Change in fasting glucose (mmol/l)
Measured: cycle 1 (day 5; day 20) and cycle 3 (day 5; day 20), (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days)
Mean change in fasting Insulin
Change in fasting Insulin (mU/l)
Measured: cycle 1 (day 5; day 20) and cycle 3 (day 5; day 20), (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days)
Mean change in blood lipid serum level: cholesterol
Change in cholesterol (mmol/l)
Measured: cycle 1 (day 5; day 20) and cycle 3 (day 5; day 20), (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days)
Mean change in blood lipid serum level: LDL
Change in LDL (mmol/l)
Measured: cycle 1 (day 5; day 20) and cycle 3 (day 5; day 20), (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days)
Mean change in blood lipid serum level: HDL
Change in HDL (mmol/l)
Measured: cycle 1 (day 5; day 20) and cycle 3 (day 5; day 20), (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days)
Mean change in blood lipid serum level: triglycerides
Change in triglycerides (mmol/l)
Measured: cycle 1 (day 5; day 20) and cycle 3 (day 5; day 20), (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start1 Nov 2019
- Primary completion27 May 2021
- Study completion27 May 2021
Why it stopped: massive recruitment problems became apparent because of the strict inclusion criteria of our study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Petra Stute, Prof, Principal investigator, University Hospital Berne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140968
- Sponsor's protocol ID
- 2018-01240
- Other IDs
- 2018
- Acronym
- P4&REE
- Status last verified
- Mar 2022
- First submitted
- 27 Sep 2019
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Progesterone Substitution in Luteal Phase on Resting Energy Expenditure in Women During Menopausal Transition.
- ClinicalTrials.gov ID
- NCT04140968
- Acronym / sponsor ID
- P4&REE / 2018-01240
- Conditions
- Menopause, Progesterone, Weight Gain
- Keywords
- Resting energy expenditure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: massive recruitment problems became apparent because of the strict inclusion criteria of our study.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 27 May 2021 (actual)
- Study completion
- 27 May 2021 (actual)
- First posted
- 28 Oct 2019 (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.
This study evaluates the effect of micronized progesterone substitution in the luteal phase on resting energy expenditure in women during menopausal transition.
Detailed description
The majority of women report an increase of body weight of about 0.5 kg/year during the menopausal transition. However, the weight gain has not been attributed to menopause itself but rather to, e.g., a decrease of the basal metabolic rate due to aging, less energy expenditure and a non-adapted caloric intake.
One of the first signs of the menopausal transition is a change in the bleeding pattern due to a disruption of the hypothalamus-pituitary-ovary-axis. The number of cycles with an insufficient luteal phase and anovulatory cycles with an insufficient or even absent luteal phase increase as the menopausal transition proceeds. Thus, in perimenopausal women progesterone endogenous exposure decreases in quantity and duration. By substituting progesterone during the luteal phase, irregular cycle and bleeding patterns can be normalized. However, besides the beneficial effects of progesterone on the course of a menstrual cycle it displays some features that may be preventive for weight gain.
In this study only women in their early menopausal transition with menstrual cycle irregularities are included. By substituting progesterone during luteal phase the investigator tries to normalize their menstrual cycle pattern. The hypothesis is, that progesterone might not only normalize the menstrual cycle pattern of women in their early menopausal transition but due to its metabolic activities, progesterone may also increase the resting energy expenditure and thus may prevent weight gain during the menopausal transition. Furthermore the effect of progesterone substitution on the expression of miRNAs which are included in glucose- and lipid-metabolism such as miR-370 and miR-29 will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Utrogestan | Experimental | Drug: Utrogestan300mg Utrogestan (1 tablet 100mg + 1 tablet 200mg)by mouth,every day in the second and third menstrual cycle daily from cycle day 15 to 26. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women during early menopausal transition (MT) with indication for luteal phase progesterone substitution (definition of early MT: change of cycle length (shorter or longer menstrual cycle) of at least ≥ 7 days from normal and/or phases of amenorrhea of up to < 60 days during the preceding 12 months)
- Body Mass Index (BMI) 18.5 - 24.9 kg/m2
- Informed Consent as documented by signature
Key exclusion criteria (17 listed)
- Pregnancy or Lactation
- Systemic hormone therapy or hormonal contraception (estradiol, progestogen, androgen) during the study and within 12 weeks prior to study entry
- Phytotherapeutics for menstrual cycle regulation during the study and within 12 weeks prior to study entry
- Active psychiatric disease
- Use of psychotropic drugs during the study and within 12 weeks prior to study entry
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 |
|---|---|---|
| Utrogestan300mg Utrogestan (1 tablet 100mg + 1 tablet 200mg) in the second and third menstrual cycle daily from cycle day 15 to 26. | Drug | Utrogestan |
Primary outcome
Mean change in resting energy expenditure
Time frame: cycle 1 (day 20) to cycle 3 (day 20), (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days)
Change in resting energy expenditure (kcal/day) from cycle 1 due to substitution of Utrogestan in luteal phase
13 secondary outcomes
Mean change in miRNA expression
Time frame: cycle 1 (day 5; day 20) and cycle 3 (day 5; day 20), (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days)
Mean change in energy intake
Time frame: cycle 1 (day 17-19) and cycle 3 (day 17-19), (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days)
Mean change in body core temperature
Time frame: cycle 1-3 during luteal phase, (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days)
Mean change in serum hormone profile FSH
Time frame: cycle 1 (day 5; day 20) and cycle 3 (day 5; day 20), (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days)
Mean change in serum hormone profile LH
Time frame: cycle 1 (day 5; day 20) and cycle 3 (day 5; day 20), (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days)
Mean change in serum hormone profile estradiol
Time frame: cycle 1 (day 5; day 20) and cycle 3 (day 5; day 20)
Mean change in serum hormone profile progesterone
Time frame: cycle 1 (day 5; day 20) and cycle 3 (day 5; day 20), (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days)
Mean change in fasting glucose
Time frame: cycle 1 (day 5; day 20) and cycle 3 (day 5; day 20), (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days)
Mean change in fasting Insulin
Time frame: cycle 1 (day 5; day 20) and cycle 3 (day 5; day 20), (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days)
Mean change in blood lipid serum level: cholesterol
Time frame: cycle 1 (day 5; day 20) and cycle 3 (day 5; day 20), (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days)
Mean change in blood lipid serum level: LDL
Time frame: cycle 1 (day 5; day 20) and cycle 3 (day 5; day 20), (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days)
Mean change in blood lipid serum level: HDL
Time frame: cycle 1 (day 5; day 20) and cycle 3 (day 5; day 20), (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days)
Mean change in blood lipid serum level: triglycerides
Time frame: cycle 1 (day 5; day 20) and cycle 3 (day 5; day 20), (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days)
Results and safety
The study was stopped early (reason given: massive recruitment problems became apparent because of the strict inclusion criteria of our study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- 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. This study is not recruiting at the moment.
Petra Stute, Prof principal investigator
University Hospital Berne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Utrogestan in people with Menopause and Progesterone, run by Insel Gruppe AG, University Hospital Bern 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 3 inclusion and 17 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: stopped early, as of the sponsor's last update on 31 Mar 2022. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: massive recruitment problems became apparent because of the strict inclusion criteria of our study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in resting energy expenditure (time frame: cycle 1 (day 20) to cycle 3 (day 20), (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days)). 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 31 Mar 2022.