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Progesterone and Resting Energy Expenditure (P4&REE)

Primary Purpose

Menopause, Progesterone, Weight Gain

Status

Terminated

Phase

Phase 4

Locations

Switzerland

Study Type

Interventional

Intervention

Utrogestan

About this trial

This is an interventional treatment trial for Menopause focused on measuring Resting energy expenditure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
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.

Sites / Locations

Dep. of Obstetrics and Gynecology, Bern University Hospital, Bern

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Utrogestan

Arm Description

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.

Outcomes

Primary Outcome Measures

Mean change in resting energy expenditure

Change in resting energy expenditure (kcal/day) from cycle 1 due to substitution of Utrogestan in luteal phase

Secondary Outcome Measures

Mean change in miRNA expression

Change in miRNA expression (miR-370, miR-29b)

Mean change in energy intake

Change in energy intake (kcal/day)

Mean change in body core temperature

Change in body core temperature (°C)

Mean change in serum hormone profile FSH

Change in serum hormone profile: FSH (U/l)

Mean change in serum hormone profile LH

Change in serum hormone profile: LH (U/l)

Mean change in serum hormone profile estradiol

Change in serum hormone profile: estradiol (pmol/l)

Mean change in serum hormone profile progesterone

Change in serum hormone profile: progesterone (nmol/l)

Mean change in fasting glucose

Change in fasting glucose (mmol/l)

Mean change in fasting Insulin

Change in fasting Insulin (mU/l)

Mean change in blood lipid serum level: cholesterol

Change in cholesterol (mmol/l)

Mean change in blood lipid serum level: LDL

Change in LDL (mmol/l)

Mean change in blood lipid serum level: HDL

Change in HDL (mmol/l)

Mean change in blood lipid serum level: triglycerides

Change in triglycerides (mmol/l)

Full Information

NCT ID

NCT04140968

First Posted

September 27, 2019

Last Updated

March 15, 2022

Sponsor

Insel Gruppe AG, University Hospital Bern

1. Study Identification

Unique Protocol Identification Number

NCT04140968

Brief Title

Progesterone and Resting Energy Expenditure

Acronym

P4&REE

Official Title

Impact of Progesterone Substitution in Luteal Phase on Resting Energy Expenditure in Women During Menopausal Transition.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Terminated

Why Stopped

massive recruitment problems became apparent because of the strict inclusion criteria of our study.

Study Start Date

November 1, 2019 (Actual)

Primary Completion Date

May 27, 2021 (Actual)

Study Completion Date

May 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Insel Gruppe AG, University Hospital Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Menopause, Progesterone, Weight Gain

Keywords

Resting energy expenditure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Utrogestan

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Utrogestan

Intervention Description

300mg Utrogestan (1 tablet 100mg + 1 tablet 200mg) in the second and third menstrual cycle daily from cycle day 15 to 26.

Primary Outcome Measure Information:

Title

Mean change in resting energy expenditure

Description

Change in resting energy expenditure (kcal/day) from cycle 1 due to substitution of Utrogestan in luteal phase

Time Frame

cycle 1 (day 20) to cycle 3 (day 20), (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days)

Secondary Outcome Measure Information:

Title

Mean change in miRNA expression

Description

Change in miRNA expression (miR-370, miR-29b)

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)

Title

Mean change in energy intake

Description

Change in energy intake (kcal/day)

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)

Title

Mean change in body core temperature

Description

Change in body core temperature (°C)

Time Frame

cycle 1-3 during luteal phase, (cycle 1 has individual length, <60 days, cycle 2&3 are 28 days)

Title

Mean change in serum hormone profile FSH

Description

Change in serum hormone profile: FSH (U/l)

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)

Title

Mean change in serum hormone profile LH

Description

Change in serum hormone profile: LH (U/l)

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)

Title

Mean change in serum hormone profile estradiol

Description

Change in serum hormone profile: estradiol (pmol/l)

Time Frame

cycle 1 (day 5; day 20) and cycle 3 (day 5; day 20)

Title

Mean change in serum hormone profile progesterone

Description

Change in serum hormone profile: progesterone (nmol/l)

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)

Title

Mean change in fasting glucose

Description

Change in fasting glucose (mmol/l)

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)

Title

Mean change in fasting Insulin

Description

Change in fasting Insulin (mU/l)

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)

Title

Mean change in blood lipid serum level: cholesterol

Description

Change in cholesterol (mmol/l)

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)

Title

Mean change in blood lipid serum level: LDL

Description

Change in LDL (mmol/l)

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)

Title

Mean change in blood lipid serum level: HDL

Description

Change in HDL (mmol/l)

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)

Title

Mean change in blood lipid serum level: triglycerides

Description

Change in triglycerides (mmol/l)

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)

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Petra Stute, Prof

Organizational Affiliation

University Hospital Berne

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dep. of Obstetrics and Gynecology, Bern University Hospital, Bern

City

Berne

ZIP/Postal Code

3010

Country

Switzerland

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Progesterone and Resting Energy Expenditure

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