Hot FlushesPhase 3NCT01464697
Progesterone for Perimenopausal Night Sweats
A Phase 3 study testing Oral micronized progesterone in people with Hot Flushes and Night Sweats, run by University of British Columbia at 1 site in Canada.
Trial summary
The purpose of this study is to test whether a oral micronized progesterone reduces the Vasomotor Symptom Score comprised of the number and severity of hot flushes and night sweats in perimenopausal women. Oral micronized progesterone is molecularly identical to human progesterone, a steroid hormone. Read more about this study
- Who is it for?
- Ages 35 to 58 years, women only
- Conditions the study is for
- Hot Flushes, Night Sweats
- What is being tested?
- Oral micronized progesterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 249 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2011to 1 Jun 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 58 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Between 35-58 years of age
- At least 4 vasomotor symptoms (VMS) per day, on average, for at least 2/4 weeks or at least 56 over a four-week period. In addition, women should report having VMS of moderate or severe rather than mild intensity. Women reporting fewer VMS than this, but who report night sweats that awaken them from sleep on two or more nights per week will also be included.
- Perimenopausal status either based on irregularity of menstrual periods, or by onset of new perimenopausal symptoms in women with regular periods.
- At least one menstrual period within 12 months of study enrollment
- Ability and willingness to complete the Daily Perimenopause Hot Flush Calendar recording instrument.
- Ability to understand, speak, read and write English.
- Women who are at high risk for breast cancer (ie first degree relative with breast cancer, known/suspected history of breast cancer) will be required to have a normal mammogram and clinical breast examination within 12 months of study enrollment.
Who cannot join
- VMS without perimenopausal etiology.
- Women who have had a hysterectomy and/or ovariectomy.
- Peanut allergy (because peanut oil is used in the progesterone formulation.)
- Current or recent (within the last 6-mos.) use of hormonal therapies (estrogen, progesterone, hormonal contraceptives, hormonal fertility treatments), or plans to initiate use during the study period. Two exceptions: women using progestin-releasing intrauterine device (IUD) will not be excluded as it is felt that level of hormone released will not have an effect on VMS and women taking very low-dose transdermal progesterone therapies who have VMS and meet inclusion criteria will be considered on a case-by-case basis. If enrolled, women with these exclusion exceptions will be required to continue and document use of these therapies throughout the entire trial.
- Planned pregnancy or fertility treatment during the study period.
- Women who are breastfeeding.
- Participants with a score greater or equal to 15 on the Personal Health Questionnaire (PHQ-9) will be assessed on a case-by-case basis. Women assessed as needing further investigation and/or treatment for depression will be excluded.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Participation from home or in-person at University of British Columbia/Centre for Menstrual Cycle and Ovulation Research (CeMCOR)/Women's Health Research Institute
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: Oral Micronized Progesterone for Perimenopausal Vasomotor Symptoms
The purpose of this study is to test whether a oral micronized progesterone reduces the Vasomotor Symptom Score comprised of the number and severity of hot flushes and night sweats in perimenopausal women. Oral micronized progesterone is molecularly identical to human progesterone, a steroid hormone. It is sold by prescription for use to prevent endometrial cancer in women taking estrogen in menopause. This research study will test whether progesterone reduces perimenopausal hot flushes and night sweats. It will also test whether progesterone improves sleep disturbances and anxiety.
Read the detailed description
This is a randomized, double-blind placebo-controlled trial of oral micronized progesterone (300 mg daily at bedtime) for perimenopausal women living anywhere in Canada. Using the self-reported maximum menstrual cycle length in the previous year, women will be stratified as in Early Perimenopause (<60 days) or Late Perimenopause (>=60 days). The design includes a 28-day baseline run-in followed by 12 weeks of randomized therapy.
- Conditions
- Hot Flushes, Night Sweats
- Being tested
- Oral micronized progesterone, placebo
- Keywords
- hot flushes/hot flashes, night sweats, sleep problems, negative mood, anxiety, perimenopause, progesterone, vasomotor symptoms, depression, women's perceived change, perimenopause interference questionnaire
- Medical subject headings
- Hot Flashes, Parasomnias, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral micronized progesteroneDrug
Also called Prometrium, Utrogestan
300 mg as 3-100 mg capsules taken orally at bedtime daily for 12 weeks
placeboDrug
placebo comparator, taken as 3 round capsules at bedtime daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| oral micronized progesterone | Experimental | Oral micronized progesterone is Prometrium 300 mg at bedtime daily Receives: Drug: Oral micronized progesterone |
| Placebo Comparator | Placebo comparator | Placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vasomotor Symptoms (VMS)/ VMS Score - at 12 Weeks
Participants will complete a daily calendar (Daily Perimenopause Hot Flush Calendar) to record frequency (actual number) and severity (quantified by ordinal scale ie 0=none to 4=extreme) of hot flushes and night sweats. The VMS Score will be calculated as follows:
Daily VMS Score = (# night sweats) x (severity) + (#hot flushes) x (severity).
Outcome is the average daily VMS Score during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate.
Measured: 12 weeks
Frequency of VMS
Frequency (count) of hot flushes/hot flashes and night sweats per day from prospective daily calendar records. Outcome is the average daily VMS Frequency (day + night) during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate.
Measured: 12 weeks
Severity of VMS
Severity (0-4, 0=no intensity, 4=extreme intensity) of hot flushes/hot flashes and night sweats per day from prospective daily calendar records. Daily summary score is the maximum of daytime and nighttime severity. Outcome is the average daily severity during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate.
Measured: 12 weeks
VMS Score by Early Perimenopause
subgroup analysis of VMS Score by Early Perimenopause (no skipped period or <60 day cycle length). Outcome is the average daily VMS Score during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate. Participants will complete a daily calendar (Daily Perimenopause Hot Flush Calendar) to record frequency (actual number) and severity (quantified by ordinal scale ie 0=none to 4=extreme) of hot flushes and night sweats. The VMS Score will be calculated as follows: Daily VMS Score = (# night sweats) x (severity) + (#hot flushes) x (severity).
Measured: 12 weeks
VMS Score by Late Perimenopause
subgroup analysis of VMS Score by Late Perimenopause (those with skipped or ≥60 day cycle lengths). Outcome is the average daily VMS Score during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate. Participants will complete a daily calendar (Daily Perimenopause Hot Flush Calendar) to record frequency (actual number) and severity (quantified by ordinal scale ie 0=none to 4=extreme) of hot flushes and night sweats. The VMS Score will be calculated as follows: Daily VMS Score = (# night sweats) x (severity) + (#hot flushes) x (severity).
Measured: 12 weeks
Subgroup Analysis for Those With Frequent and Severe VMS - VMS Score
VMS Score for those with more frequent (≥7 per day and moderate to severe episodes of intensity 2-4) at baseline. Participants will complete a daily calendar (Daily Perimenopause Hot Flush Calendar) to record frequency (actual number) and severity (quantified by ordinal scale ie 0=none to 4=extreme) of hot flushes and night sweats. The VMS Score will be calculated as follows:
Daily VMS Score = (# night sweats) x (severity) + (#hot flushes) x (severity).
Measured: 12 weeks
Secondary outcomes (18)
Sleep Problems
Daily average rating of sleep problems (0-4) from prospective daily calendar records.
Outcome is the average daily rating during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate. Scale name: Sleep Problems (4=Worst, 0=None)
Measured: 12 weeks
Anxiety
Daily average rating of anxiety (0-4) from prospective daily calendar records. Outcome is the average daily rating during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate. Scale name: Anxiety (4=Worst, 0=None)
Measured: 12 weeks
Women's Perceived Changes in Daytime Hot Flushes for Whole Population
Women's Perceived Changes Questionnaire of changes (from -5 to 0 to +5) in Daytime Hot Flushes (both number and severity) as recorded on the Final Questionnaire.
Scale Name: Daytime Hot Flush Change Decrease is -5 to -1; No change is 0; Increase is +1 to +5. This is women's perception of the change from run-in to when they recorded it at the end of the trial (at 12 weeks).
No calculation is needed.
Measured: 12 weeks
Women's Perceived Changes in Night Sweats for Whole Population
Women's Perceived Changes Questionnaire of changes (from -5 to 0 to +5) in Nighttime Night Sweats (both number and severity) as recorded on the Final Questionnaire.
Scale Name: Night Sweats Change Decrease is -5 to -1; No change is 0; Increase is +1 to +5. This is women's perception of the change from run-in to when they recorded it at the end of the trial (at 12 weeks).
No calculation is needed.
Measured: 12 weeks
Women's Perceived Changes in Quality of Sleep for Whole Population
Women's Perceived Changes Questionnaire of changes (from -5 to 0 to +5) in the quality of sleep over the three months of the trial as assessed by the Final Questionnaire based on their random assignment to the progesterone or placebo arms of this RCT (Randomized Controlled Trial) and by Early/Late perimenopause.
Scale Name: Quality of Sleep Change Decrease is -5 to -1; No change is 0; Increase is +1 to +5. This is women's perception of the change from run-in to when they recorded it at the end of the trial (at 12 weeks).
No calculation is needed.
Measured: 12 weeks
Perception of Interference of Overall Perimenopausal Changes With Usual Activities in Women
Final perceptions of interference of overall perimenopausal changes with usual activities (as recorded by the CeMCOR PIQ - Centre for Menstrual Cycle and Ovulation Research Perimenopause Interference Questionnaire) at 12 weeks in women randomized to the progesterone versus to placebo.
Scale Name: Perceived Interference Score: 100 mm line (0 = No Interference; 100 = Severe Interference)
Measured: 12 weeks
Perception of Interference of Overall Perimenopausal Changes With Usual Activities in Women - Early Perimenopause
Final perceptions of interference of overall perimenopausal changes with usual activities (as recorded by the CeMCOR Perimenopause Interference Questionnaire [CeMCOR PIQ]) at 12 weeks in women randomized to the progesterone versus to placebo.
Scale Name: Perceived Interference Score: 100 mm line (0 = No Interference; 100 = Severe Interference)
Measured: 12 weeks
Perception of Interference of Overall Perimenopausal Changes With Usual Activities in Women - Late Perimenopause
Final perceptions of interference of overall perimenopausal changes with usual activities (as recorded by the CeMCOR Perimenopause Interference Questionnaire [CeMCOR PIQ]) at 12 weeks in women randomized to the progesterone versus to placebo.
Scale Name: Perceived Interference Score: 100 mm line (0 = No Interference; 100 = Severe Interference)
Measured: 12 weeks
Perception of Interference of Perimenopausal Body Changes With Usual Activities in Women
Final perceptions of interference of perimenopausal body changes with usual activities (as recorded by the CeMCOR Perimenopause Interference Questionnaire [CeMCOR PIQ]) in women randomized to the progesterone versus to placebo.
Scale Name: Perceived Interference Score: 100 mm line (0 = No Interference; 100 = Severe Interference)
Measured: 12 weeks
Perception of Interference of Perimenopausal Mood Changes With Usual Activities in Women
Final perceptions of interference of perimenopausal mood changes with usual activities (as recorded by the CeMCOR Perimenopause Interference Questionnaire [CeMCOR PIQ]) in women randomized to the progesterone versus to placebo.
Scale Name: Perceived Interference Score: 100 mm line (0 = No Interference; 100 = Severe Interference)
Measured: 12 weeks
Women's Perceived Changes in Daytime Hot Flushes in Early Perimenopause
Women's Perceived Changes Questionnaire of changes (from -5 to 0 to +5) in Daytime Hot Flushes (both number and severity) as recorded on the Final Questionnaire and by subgroup for Early Perimenopause.
Scale Name: Perceived Daytime Hot Flush Change Decrease is -5 to -1; No change is 0; Increase is +1 to +5.
Measured: 12 weeks
Women's Perceived Changes in Night Sweats in Early Perimenopause
Women's Perceived Changes Questionnaire of changes (from -5 to 0 to +5) in Nighttime Night Sweats (both number and severity) as recorded on the Final Questionnaire and by subgroup for Early Perimenopause.
Scale Name: Perceived Night Sweats Change Decrease is -5 to -1; No change is 0; Increase is +1 to +5.
Measured: 12 weeks
Women's Perceived Changes in Daytime Hot Flushes in Late Perimenopause
Women's Perceived Changes Questionnaire of changes (from -5 to 0 to +5) in Daytime Hot Flushes (both number and severity) as recorded on the Final Questionnaire and by subgroup for Late Perimenopause.
Scale Name: Perceived Daytime Hot Flush Change Decrease is -5 to -1; No change is 0; Increase is +1 to +5.
Measured: 12 weeks
Women's Perceived Changes in Night Sweats in Late Perimenopause
Women's Perceived Changes Questionnaire of changes (from -5 to 0 to +5) in Nighttime Night Sweats (both number and severity) as recorded on the Final Questionnaire and by subgroup for Late Perimenopause.
Scale Name: Perceived Night Sweats Change Decrease is -5 to -1; No change is 0; Increase is +1 to +5.
Measured: 12 weeks
Depression Related to Progesterone Therapy in Whole Population
Final PHQ9 (Personal Health Questionnaire 9) Score for Depression related to progesterone therapy in perimenopause will be assessed based on the Personal Health Questionnaire-9 (PHQ-9) score changes within-woman from baseline to the end-of-trial on progesterone compared with placebo.
Scale Name: PHQ9 Scale (0 = No Depression; 27 = Severe Depression)
Measured: 12 weeks
Depression Related to Progesterone Therapy in Early Perimenopause
Final PHQ9 Score for Depression related to progesterone therapy in Early Perimenopause will be assessed based on the Personal Health Questionnaire-9 (PHQ-9) score changes within-woman from baseline to the end-of-trial on progesterone compared with placebo.
Scale Name: PHQ9 Scale (0 = No Depression; 27 = Severe Depression)
Measured: 12 weeks
Depression Related to Progesterone Therapy in Late Perimenopause
Final PHQ9 Score for Depression related to progesterone therapy in Late Perimenopause will be assessed based on the Personal Health Questionnaire-9 (PHQ-9) score changes within-woman from baseline to the end-of-trial on progesterone compared with placebo.
Scale Name: PHQ9 Scale (0 = No Depression; 27 = Severe Depression)
Measured: 12 weeks
Percentage of Women With Perceived Changes in Menstrual Flow
Menstrual flow related to progesterone therapy in perimenopause was assessed based on Women's Perceived Changes Questionnaire of changes in the experience of menstrual flow/vaginal bleeding from the Final Questionnaire.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2011 (estimated)
- Study startOct 2011
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hot FlushesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jerilynn Prior, University of British Columbia
- Investigators
- Jerilynn C Prior, MD, FRCPC, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01464697
- Sponsor's protocol ID
- H10-02975
- Status last verified
- Nov 2019
- First submitted
- 31 Oct 2011
- Last updated
- 16 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Prior JC, Hitchcock, CL. Progesterone for Vasomotor Symptoms: A 12-week Randomized, Masked Placebo-controlled Trial in Healthy, Normal-Weight Women 1-10 Years Since Final Menstrual Flow (Abstract). Endocrine Reviews 31(3): S51, 2010.
Hitchcock CL, Prior JC. Oral micronized progesterone for vasomotor symptoms--a placebo-controlled randomized trial in healthy postmenopausal women. Menopause. 2012 Aug;19(8):886-93. doi: 10.1097/gme.0b013e318247f07a.
PubMed 22453200Prior JC, Cameron A, Hitchcock CL, et al. Oral Micronized Progesterone Beneficial for Perimenopausal Hot Flushes/Flashes and Night Sweats. Endocrine Reviews 2018;39(2) Abstract-oral presentation at Endocrine Society Conference, Chicago, 2018.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Micronized Progesterone for Perimenopausal Vasomotor Symptoms
- ClinicalTrials.gov ID
- NCT01464697
- Acronym / sponsor ID
- H10-02975
- Conditions
- Hot Flushes, Night Sweats
- Keywords
- hot flushes/hot flashes, night sweats, sleep problems, negative mood, anxiety, perimenopause, progesterone, vasomotor symptoms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 3 Nov 2011 (estimated)
- Results
- Posted 16 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test whether a oral micronized progesterone reduces the Vasomotor Symptom Score comprised of the number and severity of hot flushes and night sweats in perimenopausal women. Oral micronized progesterone is molecularly identical to human progesterone, a steroid hormone. It is sold by prescription for use to prevent endometrial cancer in women taking estrogen in menopause. This research study will test whether progesterone reduces perimenopausal hot flushes and night sweats. It will also test whether progesterone improves sleep disturbances and anxiety.
Detailed description
This is a randomized, double-blind placebo-controlled trial of oral micronized progesterone (300 mg daily at bedtime) for perimenopausal women living anywhere in Canada. Using the self-reported maximum menstrual cycle length in the previous year, women will be stratified as in Early Perimenopause (<60 days) or Late Perimenopause (>=60 days). The design includes a 28-day baseline run-in followed by 12 weeks of randomized therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral micronized progesterone | Experimental | Drug: Oral micronized progesteroneOral micronized progesterone is Prometrium 300 mg at bedtime daily |
| Placebo Comparator | Placebo comparator | Drug: placeboPlacebo |
Who may qualify
- Ages
- 35 to 58 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Between 35-58 years of age
- At least 4 vasomotor symptoms (VMS) per day, on average, for at least 2/4 weeks or at least 56 over a four-week period. In addition, women should report having VMS of moderate or severe rather than mild intensity. Women reporting fewer VMS than this, but who report night sweats that awaken them from sleep on two or more nights per week will also be included.
- Perimenopausal status either based on irregularity of menstrual periods, or by onset of new perimenopausal symptoms in women with regular periods.
- At least one menstrual period within 12 months of study enrollment
- Ability and willingness to complete the Daily Perimenopause Hot Flush Calendar recording instrument.
Key exclusion criteria (7 listed)
- VMS without perimenopausal etiology.
- Women who have had a hysterectomy and/or ovariectomy.
- Peanut allergy (because peanut oil is used in the progesterone formulation.)
- Current or recent (within the last 6-mos.) use of hormonal therapies (estrogen, progesterone, hormonal contraceptives, hormonal fertility treatments), or plans to initiate use during the study period. Two exceptions: women using progestin-releasing intrauterine device (IUD) will not be excluded as it is felt that level of hormone released will not have an effect on VMS and women taking very low-dose transdermal progesterone therapies who have VMS and meet inclusion criteria will be considered on a case-by-case basis. If enrolled, women with these exclusion exceptions will be required to continue and document use of these therapies throughout the entire trial.
- Planned pregnancy or fertility treatment during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral micronized progesteroneAlso: Prometrium, Utrogestan300 mg as 3-100 mg capsules taken orally at bedtime daily for 12 weeks | Drug | oral micronized progesterone |
| placeboplacebo comparator, taken as 3 round capsules at bedtime daily for 12 weeks | Drug | Placebo Comparator |
Primary outcome
Vasomotor Symptoms (VMS)/ VMS Score - at 12 Weeks
Time frame: 12 weeks
Participants will complete a daily calendar (Daily Perimenopause Hot Flush Calendar) to record frequency (actual number) and severity (quantified by ordinal scale ie 0=none to 4=extreme) of hot flushes and night sweats. The VMS Score will be calculated as follows: Daily VMS Score = (# night sweats) x (severity) + (#hot flushes) x (severity). Outcome is the average daily VMS Score during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate.
Frequency of VMS
Time frame: 12 weeks
Frequency (count) of hot flushes/hot flashes and night sweats per day from prospective daily calendar records. Outcome is the average daily VMS Frequency (day + night) during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate.
Severity of VMS
Time frame: 12 weeks
Severity (0-4, 0=no intensity, 4=extreme intensity) of hot flushes/hot flashes and night sweats per day from prospective daily calendar records. Daily summary score is the maximum of daytime and nighttime severity. Outcome is the average daily severity during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate.
VMS Score by Early Perimenopause
Time frame: 12 weeks
subgroup analysis of VMS Score by Early Perimenopause (no skipped period or <60 day cycle length). Outcome is the average daily VMS Score during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate. Participants will complete a daily calendar (Daily Perimenopause Hot Flush Calendar) to record frequency (actual number) and severity (quantified by ordinal scale ie 0=none to 4=extreme) of hot flushes and night sweats. The VMS Score will be calculated as follows: Daily VMS Score = (# night sweats) x (severity) + (#hot flushes) x (severity).
VMS Score by Late Perimenopause
Time frame: 12 weeks
subgroup analysis of VMS Score by Late Perimenopause (those with skipped or ≥60 day cycle lengths). Outcome is the average daily VMS Score during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate. Participants will complete a daily calendar (Daily Perimenopause Hot Flush Calendar) to record frequency (actual number) and severity (quantified by ordinal scale ie 0=none to 4=extreme) of hot flushes and night sweats. The VMS Score will be calculated as follows: Daily VMS Score = (# night sweats) x (severity) + (#hot flushes) x (severity).
Subgroup Analysis for Those With Frequent and Severe VMS - VMS Score
Time frame: 12 weeks
VMS Score for those with more frequent (≥7 per day and moderate to severe episodes of intensity 2-4) at baseline. Participants will complete a daily calendar (Daily Perimenopause Hot Flush Calendar) to record frequency (actual number) and severity (quantified by ordinal scale ie 0=none to 4=extreme) of hot flushes and night sweats. The VMS Score will be calculated as follows: Daily VMS Score = (# night sweats) x (severity) + (#hot flushes) x (severity).
18 secondary outcomes
Sleep Problems
Time frame: 12 weeks
Anxiety
Time frame: 12 weeks
Women's Perceived Changes in Daytime Hot Flushes for Whole Population
Time frame: 12 weeks
Women's Perceived Changes in Night Sweats for Whole Population
Time frame: 12 weeks
Women's Perceived Changes in Quality of Sleep for Whole Population
Time frame: 12 weeks
Perception of Interference of Overall Perimenopausal Changes With Usual Activities in Women
Time frame: 12 weeks
Perception of Interference of Overall Perimenopausal Changes With Usual Activities in Women - Early Perimenopause
Time frame: 12 weeks
Perception of Interference of Overall Perimenopausal Changes With Usual Activities in Women - Late Perimenopause
Time frame: 12 weeks
Perception of Interference of Perimenopausal Body Changes With Usual Activities in Women
Time frame: 12 weeks
Perception of Interference of Perimenopausal Mood Changes With Usual Activities in Women
Time frame: 12 weeks
Women's Perceived Changes in Daytime Hot Flushes in Early Perimenopause
Time frame: 12 weeks
Women's Perceived Changes in Night Sweats in Early Perimenopause
Time frame: 12 weeks
Women's Perceived Changes in Daytime Hot Flushes in Late Perimenopause
Time frame: 12 weeks
Women's Perceived Changes in Night Sweats in Late Perimenopause
Time frame: 12 weeks
Depression Related to Progesterone Therapy in Whole Population
Time frame: 12 weeks
Depression Related to Progesterone Therapy in Early Perimenopause
Time frame: 12 weeks
Depression Related to Progesterone Therapy in Late Perimenopause
Time frame: 12 weeks
Percentage of Women With Perceived Changes in Menstrual Flow
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundPrior JC, Hitchcock, CL. Progesterone for Vasomotor Symptoms: A 12-week Randomized, Masked Placebo-controlled Trial in Healthy, Normal-Weight Women 1-10 Years Since Final Menstrual Flow (Abstract). Endocrine Reviews 31(3): S51, 2010.
- Background: PubMed 22453200Hitchcock CL, Prior JC. Oral micronized progesterone for vasomotor symptoms--a placebo-controlled randomized trial in healthy postmenopausal women. Menopause. 2012 Aug;19(8):886-93. doi: 10.1097/gme.0b013e318247f07a.
- BackgroundPrior JC, Cameron A, Hitchcock CL, et al. Oral Micronized Progesterone Beneficial for Perimenopausal Hot Flushes/Flashes and Night Sweats. Endocrine Reviews 2018;39(2) Abstract-oral presentation at Endocrine Society Conference, Chicago, 2018.
- Centre for Menstrual Cycle and Ovulation ResearchLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerilynn C Prior, MD, FRCPC principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oral micronized progesterone in people with Hot Flushes and Night Sweats, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vasomotor Symptoms (VMS)/ VMS Score - at 12 Weeks (time frame: 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01464697, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2019; AzTrials last refreshed its copy on 26 Oct 2026.