Progesterone for Perimenopausal Night Sweats
Condition: Hot Flushes; Night Sweats
MeSH terms: Hot Flashes
Intervention: Oral micronized progesterone; placebo
Intervention description: 300 mg as 3-100 mg capsules taken orally at bedtime daily for 12 weeks; placebo comparator, taken as 3 round capsules at bedtime daily for 12 weeks
Intervention MeSH terms: Progesterone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 249.0
Sex: Female
Minimum age: 35 Years
Maximum age: 58 Years
Healthy volunteers: No
Keywords: hot flushes/hot flashes; night sweats; sleep problems; negative mood; anxiety; perimenopause; progesterone; vasomotor symptoms; depression; women's perceived change; perimenopause interference questionnaire

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. 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.
    

Eligibility criteria:

        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. At least one menstrual period within 12 months of study enrollment

          5. Ability and willingness to complete the Daily Perimenopause Hot Flush Calendar
             recording instrument.

          6. Ability to understand, speak, read and write English.

          7. 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.

        Exclusion Criteria:

          1. VMS without perimenopausal etiology.

          2. Women who have had a hysterectomy and/or ovariectomy.

          3. Peanut allergy (because peanut oil is used in the progesterone formulation.)

          4. 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.

          5. Planned pregnancy or fertility treatment during the study period.

          6. Women who are breastfeeding.

          7. 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.