Medically reviewed by Dr. Kimberly Langdon Cull, M.D. on Oct. 4, 2023
Oral micronized progesterone did not yield significant improvement in vasomotor symptom scores in perimenopausal women compared to placebo in a recent study. Progesterone treatment was associated with significant perceived improvement in sleep quality, night sweats, and daytime vasomotor symptom intensity without any serious adverse events.
A double-blind, randomized, controlled trial investigated the safety and efficacy of oral micronized progesterone for reducing hot flushes and night sweats in perimenopausal women. Oral micronized progesterone was found to be an effective and well-tolerated therapy for vasomotor symptoms. The study concludes that progesterone can serve as a replacement-type therapy for perimenopausal women who are still menstruating. The study’s findings are published in the journal Scientific Reports.
A total of 189 perimenopausal women were randomized into control and progesterone groups. Approximately two-thirds of the women were in late menopause, whereas the remaining were in early menopause. The mean age of the study participants was 49.9 ± 4.6 years, and the mean body mass index (BMI) was 26.7 ± 5.9 kg/m2.
Intensity, Score, and Frequency of Vasomotor Symptoms
The mean vasomotor symptom score was 12.2 ± 11.3 years, and the average daily frequency of vasomotor symptoms was 4.9 ± 3.8 at baseline. The daytime scores were higher compared to the nighttime scores for vasomotor symptoms. There were no statistically significant differences in the experimental and control groups for vasomotor symptoms score, frequency, and intensity, measured during the third month.
Perceived Changes in Vasomotor Symptoms
There was no significant difference in the overall daytime vasomotor symptoms with progesterone treatment. However, women in the treatment group perceived a significantly greater decrease in overall night sweats, frequency of night sweats, intensity of night sweats, and daytime vasomotor symptom intensity.
Sleep, Depression, and Anxiety in Perimenopausal Women
There were no significant differences in sleep and anxiety in perimenopausal women across the two groups in the third month of treatment; however, women taking progesterone perceived a significant improvement in sleep quality and cessation of menstrual flow with progesterone compared to placebo. However, perimenopausal women reported no differences in the perceived menstrual flow changes with progesterone.
The Perimenopause Interference Questionnaire results indicated a significant improvement with progesterone compared to placebo. On the contrary, there were statistically no significant differences in the two groups for the Personal Health Questionnaire (PHQ-9) for depression in the third month.
Safety Profile of Oral Micronized Progesterone
The clinical trial did not report any serious adverse events in the study participants. Treatment discontinuation was associated with one instance of new-onset atrial fibrillation in a progesterone-treated participant and four instances of treatment ineffectiveness in placebo-treated participants. One woman from each group experienced dizziness, which may be associated with progesterone. Approximately 91.4% and 84.4% of the study participants in the progesterone and control groups demonstrated medication adherence, respectively. Mild-to-moderate side effects were more frequent in the progesterone-treated women.
Prior, J. C., Cameron, A., Fung, M., Hitchcock, C. L., Janssen, P., Lee, T., & Singer, J. (2023). Oral micronized progesterone for perimenopausal night sweats and hot flushes a Phase III Canada-wide randomized placebo-controlled 4 month trial. Scientific reports, 13(1), 9082. https://doi.org/10.1038/s41598-023-35826-w