Contact information
Type
Scientific
Primary contact
Dr Jerilynn Prior
ORCID ID
Contact details
Centre for Menstrual Cycle and Ovulation Research (CeMCOR)
Endocrinology
Department of Medicine
University of British Columbia
and
Vancouver Coastal Health Research Institute
2775 Laurel St.
4th Floor
Vancouver
BC
V5Z 1M9
Canada
+1 604 875 5927
Jerilynn.Prior@vch.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00152438
Protocol/serial number
N/A
Study information
Scientific title
Acronym
VMS Progesterone Study
Study hypothesis
1. Oral micronised progesterone (OMP) will decrease vasomotor symptoms (VMS) scores within-woman by about 75% compared with their baseline score and significantly more than placebo
2. Oral micronised progesterone will increase endothelium-dependent forearm blood flow by plethysmography within-woman over three months compared with no change on placebo
3. Oral micronised progesterone will significantly decrease blood pressure within woman compared with her baseline; there will be no change in the placebo group
4. Oral micronised progesterone will cause no within-woman change in weight, waist circumference, fasting cholesterol, HDL cholesterol, LDL or triglyceride levels compared with her own baseline and any changes in the placebo-treated women
5. Oral micronised progesterone and placebo will improve health related quality of life as documented by the Menopause-Specific Quality of Life Scale (MenQOL) and the SF-36 but the effect of progesterone will be significantly greater than that of placebo on both instruments
Protocol amendment as of 17/05/2006:
6. Oral micronised progesterone in healthy menopausal women will have effects on prothrombin fragments 1 + 2 and other markers of coagulation or fibrinolysis that are equivalent to but no worse than the effects of placebo
7a. Women stopping active therapy with OMP will show a significant increase in vasomotor symptoms compared to the last month of therapy
7b. Vasomotor symptoms will be no worse during the month of therapy discontinuation than they were in the baseline month
7c. Women in the placebo group will show no change in vasomotor symptoms between the baseline and the discontinuation month of the study
Please note that, as of 06/05/2009, the anticipated end date of this trial has been updated from 30/04/2007 to 31/10/2009.
Ethics approval
April 2006
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Menopause
Intervention
The women in this 4-month study are randomised to either the placebo or the oral micronised progesterone. The participants maintain a Daily Menopause Diary© during the period of the study to keep track of their vasomotor symptoms and other factors. Screening tests to rule out heart disease and diabetes include blood pressure and heart rate assessment, fasting blood glucose, cholesterol levels and electrocardiogram (ECG) measurement.
Interventions as of 17/05/2006:
The women in this 5-month study are randomised to either placebo or oral micronised progesterone. Participants maintian a Daily Menopause Diary© during the period of the study to keep track of their vasomotor symptoms and other factors and also to know if there is any change in symptoms when they come off the blinded therapy. Blood tests will be done to measure clotting factors in blood at the baseline and at the end of three months of blinded therapy. Screening tests to rule out heart disease and diabetes include blood pressure and heart rate assessment, fasting blood glucose, cholesterol levels and electrocardiogram (ECG) measurement.
Intervention type
Drug
Phase
Not Specified
Drug names
Progesterone (Prometrium ®)
Primary outcome measures
Current primary outcome measure as of 13/05/2009:
Vasomotor symptoms prospectively recorded during the first month compared with changes in months one, two, three and four of the trial
Previous primary outcome measures:
1. Vasomotor symptoms prospectively recorded during the first month compared with changes in months one, two, three and four of the trial
2. Forearm blood flow by plethysmography prospectively measured before and after three months of Oral micronised progesterone or placebo therapy
3. Clotting factors, fasting lipids, blood pressure, waist circumference and weight; these changes by Oral micronised progesterone and placebo will provide new and important therapy effects
4. Hormone-related and general quality of life measures using the standardised Menopause-Specific Quality of Life Scale, the SF-36 instrument and Daily Menopause Diary items related to sleep, mood and energy
5. Other cardiovascular markers including C-Reactive Protein (CRP) and Apolipoprotein B (ApoB)
Secondary outcome measures
Added as of 13/05/2009:
1. Forearm blood flow by plethysmography prospectively measured before and after three months of Oral micronised progesterone or placebo therapy
2. Clotting factors, fasting lipids, blood pressure, waist circumference and weight; these changes by Oral micronised progesterone and placebo will provide new and important therapy effects
3. Hormone-related and general quality of life measures using the standardised Menopause-Specific Quality of Life Scale, the SF-36 instrument and Daily Menopause Diary items related to sleep, mood and energy
4. Other cardiovascular markers including C-Reactive Protein (CRP) and Apolipoprotein B (ApoB)
Overall trial start date
01/01/2003
Overall trial end date
31/10/2009
Reason abandoned
Eligibility
Participant inclusion criteria
Women past menopause who are between one and ten years of their last menstrual period, not on any hormones for at least the past 6 months, experiencing hot flushes or night sweats and without any history or risk factors of heart disease (smoking, overweight, high lipid levels).
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
165
Participant exclusion criteria
Amendment to protocol as of 17/05/2006:
1. Any menstruation in the preceding year
2. History of hysterectomy without ovariectomy unless she is 60 years of age
3. Use of ovarian hormone therapy (estrogen, progestin, progesterone or androgen) in the preceding six months
4. Any risk factors for heart disease like smoker, high blood pressure, high cholesterol, diabetes, overweight, and history of angina or abnormal electrocardiogram (ECG)
Recruitment start date
01/01/2003
Recruitment end date
31/10/2009
Locations
Countries of recruitment
Canada
Trial participating centre
Centre for Menstrual Cycle and Ovulation Research (CeMCOR)
Vancouver, BC
V5Z 1M9
Canada
Sponsor information
Organisation
Centre for Menstrual Cycle and Ovulation Research (CeMCOR) (Canada)
Sponsor details
Endocrinology
Department of Medicine
University of British Columbia
and
Vancouver Coastal Health Research Institute
2775 Laurel St.
4th Floor
Vancouver
BC
V5Z 1M9
Canada
+1 604 875 5927
cemcor@interchange.ubc.ca
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
This study is independently funded, by donations to the Centre for Menstrual Cycle and Ovulation Research (CeMCOR).
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24465425
Publication citations
-
Results
Prior JC, Elliott TG, Norman E, Stajic V, Hitchcock CL, Progesterone therapy, endothelial function and cardiovascular risk factors: a 3-month randomized, placebo-controlled trial in healthy early postmenopausal women., PLoS ONE, 2014, 9, 1, e84698, doi: 10.1371/journal.pone.0084698.