Progesterone and Resting Energy Expenditure

NCT04140968 | Terminated Phase 4 DMC

• 1 other identifier: 2018-01240
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effect of micronized progesterone substitution in the luteal phase on resting energy expenditure in women during menopausal transition.

Conditions

Menopause; Progesterone; Weight Gain

Keywords

Resting energy expenditure

Outcome Measures

Primary Outcomes (1)

• Mean change in resting energy expenditure

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

  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

  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

  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

  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

  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

  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)

Study Arms (1)

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.

Drug: Utrogestan

Interventions

Utrogestan DRUG

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

Utrogestan

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

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

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Weight Gain

Interventions

Utrogestan

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Petra Stute, Prof

  University Hospital Berne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2019
• First Posted: October 28, 2019
• Study Start: November 1, 2019
• Primary Completion: May 27, 2021
• Study Completion: May 27, 2021
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)