Trial · NCT01464697

Progesterone for Perimenopausal Night Sweats

NCT01464697, Phase 3, Completed, University of British Columbia; results first posted 2019-12-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Progesterone for Perimenopausal Night Sweats. Trials, record NCT01464697. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01464697

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Progesterone for Perimenopausal Night Sweats
NCT number: NCT01464697
Status: Completed
Phases: Phase 3
Enrollment: 249 participants, actual
Lead sponsor: University of British Columbia
Conditions: Hot Flushes, Night Sweats
Interventions: Oral micronized progesterone, placebo
First posted: 2011-11-03
Last updated: 2019-12-16
Results first posted: 2019-12-16
Limitations and caveats: Given no previous RCT of VMS only in perimenopause, despite a blinded study assessment, we were still under powered. Women's Perceived Changes assessments, were not congruent with the VMS Score.

Source ClinicalTrials.gov

Registered outcomes24

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Vasomotor Symptoms (VMS)/ VMS Score - at 12 Weeks	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.
Primary	Frequency of VMS	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.
Primary	Severity of VMS	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.
Primary	VMS Score by Early Perimenopause	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).
Primary	VMS Score by Late Perimenopause	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).
Primary	Subgroup Analysis for Those With Frequent and Severe VMS - VMS Score	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).
Secondary	Sleep Problems	12 weeks	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)
Secondary	Anxiety	12 weeks	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)
Secondary	Women's Perceived Changes in Daytime Hot Flushes for Whole Population	12 weeks	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.
Secondary	Women's Perceived Changes in Night Sweats for Whole Population	12 weeks	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.

1 to 10 of 24Source ClinicalTrials.gov

See all 24 registered outcomes

Outcomes24

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Vasomotor Symptoms (VMS)/ VMS Score - at 12 Weeks	12 weeks	Intent to Treat Population	Units of Vasomotor Symptom Score	MEAN
PRIMARY	Frequency of VMS	12 weeks		episodes per day	MEAN
PRIMARY	Severity of VMS	12 weeks		Units on a Scale of 0-4	MEAN
PRIMARY	VMS Score by Early Perimenopause	12 weeks		Units of Vasomotor Symptom Score	MEAN
PRIMARY	VMS Score by Late Perimenopause	12 weeks		Units of Vasomotor Symptom Score	MEAN
PRIMARY	Subgroup Analysis for Those With Frequent and Severe VMS - VMS Score	12 weeks		Units of Vasomotor Symptom Score	MEAN
SECONDARY	Sleep Problems	12 weeks		Units on a ordinal Scale	MEAN
SECONDARY	Anxiety	12 weeks		Units on a ordinal Scale	MEAN
SECONDARY	Women's Perceived Changes in Daytime Hot Flushes for Whole Population	12 weeks		Change Scale -5 to +5, no change is 0	MEAN
SECONDARY	Women's Perceived Changes in Night Sweats for Whole Population	12 weeks		Change Scale -5 to +5, no change is 0	MEAN

1 to 10 of 24Source ClinicalTrials.gov

See all 24 outcomes

Results by group48

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Vasomotor Symptoms (VMS)/ VMS Score - at 12 Weeks	Oral Micronized Progesterone	5.5	Standard Deviation 8.2	Units of Vasomotor Symptom Score
Vasomotor Symptoms (VMS)/ VMS Score - at 12 Weeks	Placebo Comparator	7.1	Standard Deviation 10.4	Units of Vasomotor Symptom Score
Frequency of VMS	Oral Micronized Progesterone	2.4	Standard Deviation 2.7	episodes per day
Frequency of VMS	Placebo Comparator	3.0	Standard Deviation 3.7	episodes per day
Severity of VMS	Oral Micronized Progesterone	1.4	Standard Deviation 1.0	Units on a Scale of 0-4
Severity of VMS	Placebo Comparator	1.5	Standard Deviation 1.0	Units on a Scale of 0-4
VMS Score by Early Perimenopause	Oral Micronized Progesterone	4.4	Standard Deviation 7.4	Units of Vasomotor Symptom Score
VMS Score by Early Perimenopause	Placebo Comparator	3.9	Standard Deviation 4.0	Units of Vasomotor Symptom Score
VMS Score by Late Perimenopause	Oral Micronized Progesterone	5.9	Standard Deviation 8.5	Units of Vasomotor Symptom Score
VMS Score by Late Perimenopause	Placebo Comparator	8.8	Standard Deviation 12.3	Units of Vasomotor Symptom Score

1 to 10 of 48Source ClinicalTrials.gov

See all 48 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Oral Micronized Progesterone	93
Overall Study	STARTED	Placebo Comparator	96
Overall Study	COMPLETED	Oral Micronized Progesterone	90
Overall Study	COMPLETED	Placebo Comparator	86
Overall Study	NOT COMPLETED	Oral Micronized Progesterone	3
Overall Study	NOT COMPLETED	Placebo Comparator	10

Source ClinicalTrials.gov

Adverse events16

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Musculoskeletal, arthritis, connective tissue issues	Musculoskeletal and connective tissue disorders	Oral Micronized Progesterone	6	93
other	Musculoskeletal, arthritis, connective tissue issues	Musculoskeletal and connective tissue disorders	Placebo Comparator	1	96
other	Nausea, GI tract problems	Gastrointestinal disorders	Oral Micronized Progesterone	8	93
other	Nausea, GI tract problems	Gastrointestinal disorders	Placebo Comparator	1	96
other	Dizziness	General disorders	Oral Micronized Progesterone	1	93
other	Dizziness	General disorders	Placebo Comparator	1	96
other	Edema, atrial fibrillation, increased blood pressure, and headache	Cardiac disorders	Oral Micronized Progesterone	5	93
other	Edema, atrial fibrillation, increased blood pressure, and headache	Cardiac disorders	Placebo Comparator	3	96
other	Worsening VMS	Reproductive system and breast disorders	Oral Micronized Progesterone	0	93
other	Worsening VMS	Reproductive system and breast disorders	Placebo Comparator	1	96

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Oral Micronized Progesterone	0	93
Total, all-cause mortality	Placebo Comparator	0	96
Total, other adverse events	Oral Micronized Progesterone	22	93
Total, other adverse events	Placebo Comparator	8	96
Total, serious adverse events	Oral Micronized Progesterone	0	93
Total, serious adverse events	Placebo Comparator	0	96

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22453200	BACKGROUND

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Oral Micronized Progesterone vs Placebo Comparator: Percentage of Women With Perceived Changes in Menstrual Flow	Trial comparisons
Oral Micronized Progesterone vs Placebo Comparator: deaths from any cause	Trial comparisons
Oral Micronized Progesterone vs Placebo Comparator: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01464697

GET https://conductscience.org/api/trials/v1/NCT01464697/registered?page=2

API reference For AI assistants