A Phase 4 interventional study of Utrogestan in Menopause, Progesterone and Weight Gain, sponsored by Insel Gruppe AG, University Hospital Bern. Terminated at 1 site in Switzerland. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-31.
Sponsored by Insel Gruppe AG, University Hospital Bern · Phase 4, Interventional, and Treatment
This study evaluates the effect of micronized progesterone substitution in the luteal phase on resting energy expenditure in women during menopausal transition.
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.
405 studies on the registry are indexed under Weight Gain; 52 are open to participants now.
This study's enrollment of 2 is below the median of 83 across 324 interventional studies indexed under Weight Gain.
Browse Weight Gain studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Utrogestan
300mg Utrogestan (1 tablet 100mg + 1 tablet 200mg) in the second and third menstrual cycle daily from cycle day 15 to 26.
Mean change in resting energy expenditure
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)
Mean change in miRNA expression
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)
Mean change in energy intake
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)
Mean change in body core temperature
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)
Mean change in serum hormone profile FSH
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)
Mean change in serum hormone profile LH
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)
Mean change in serum hormone profile estradiol
Change in serum hormone profile: estradiol (pmol/l)
Time frame: 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)
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
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)
Mean change in fasting Insulin
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)
Mean change in blood lipid serum level: cholesterol
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)
Mean change in blood lipid serum level: LDL
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)
Mean change in blood lipid serum level: HDL
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)
Mean change in blood lipid serum level: triglycerides
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)
Plan to share: No
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Insel Gruppe AG, University Hospital Bern