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Oral Micronized Progesterone for Perimenopausal Vasomotor Symptoms

Phase 3
35 Years
58 Years
Open (Enrolling)
Hot Flushes, Night Sweats

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Trial Information

Oral Micronized Progesterone for Perimenopausal Vasomotor Symptoms

This is a randomized, 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.

Inclusion Criteria:

1. Between 35-58 years of age

2. 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.

3. Perimenopausal status either based on irregularity of menstrual periods, or by onset
of new perimenopausal symptoms in women with regular periods.

4. Ability and willingness to complete the Daily Perimenopause Diary recording

5. Ability to understand, speak, read and write English.

6. Normal clinical breast examination within the 12 months of study enrollment (Health
Canada requirement).

7. If over 40, normal mammogram within 12 months of study enrollment (Health Canada

Exclusion Criteria:

1. Less than 35 or greater than 58 years of age

2. No VMS, or VMS not meeting inclusion criteria, or VMS without perimenopausal etiology

3. More than 1-yr without menstrual flow, including those with a hysterectomy, +/-

4. Peanut allergy (because peanut oil is used in the progesterone formulation)

5. Current or recent (within the last 6-mos.) use of hormonal therapies (estrogen,
progesterone, progestin-releasing IUD, hormonal contraceptives, hormonal fertility
treatments), or plans to initiate use during the study period

6. Planned pregnancy or fertility treatment during the study period

7. Inability to understand, speak, read and write English

8. Women age 40 or older without a normal mammogram within 12 months of study enrollment
(Health Canada requirement).

9. Women who have not had a normal clinical breast examination within 12 months of study
enrollment (Health Canada requirement).

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Vasomotor Symptoms (VMS)/ VMS Score

Outcome Description:

Participants will complete a daily diary (Daily Perimenopause Diary; to record frequency and severity (quantified by numerical 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.

Outcome Time Frame:

12 weeks

Safety Issue:


Principal Investigator

Jerilynn C Prior, MD FRCPC

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of British Columbia


Canada: Health Canada

Study ID:




Start Date:

October 2011

Completion Date:

June 2014

Related Keywords:

  • Hot Flushes
  • Night Sweats
  • hot flushes
  • night sweats
  • sleep problems
  • negative mood
  • anxiety
  • perimenopause
  • progesterone
  • vasomotor symptoms
  • premenopause
  • Flushing
  • Hot Flashes