Condition category
Urological and Genital Diseases
Date applied
09/02/2005
Date assigned
10/05/2005
Last edited
31/01/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.cemcor.ubc.ca

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

  1. 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.

Additional files

Editorial Notes