Table 3.
Adverse events on oral micronized progesterone (300 mg at bedtime) or Placebo in perimenopausal women participating in a randomized double blind 12-Week trial for hot flushes and night sweats (n = 189).
| Adverse event | Progesterone N = 93 |
Control N = 96 |
|
|---|---|---|---|
| 1 | Musculoskeletal, arthritis, connective tissue issues | 6 (6.5%) | 1 (1.1%) |
| 2 | Nausea, GI tract problems | 8 (8.3%) | 1 (1.1%) |
| 3 | Dizziness^ | 1 (1.0%) | 1 (1.1%) |
| 4 | Edema, **atrial fibrillation, increased blood pressure, and headache | 5 (5.2%) | 3 (3.2%) |
| 5 | Worsening VMS | 0 | *1 (1.1%) |
| 6 | Post-traumatic stress | 0 | 1 (1.1%) |
| 7 | Probable depression | 1 (1.0%) | 0 |
| 8 | Facial acne | 1 (1.0%) | 0 |
*Discontinuation related to an adverse event on placebo.
**Family Physician-mandated discontinuation from progesterone experimental therapy.
^The only experience potentially related to progesterone therapy in blinded adjudication.