From the Guidelines
Progesterone alone is not FDA-approved for the treatment of hot flash symptoms 1.
Key Points
- The FDA has approved hormone therapy for short-term treatment of menopausal symptoms, such as vasomotor hot flashes or urogenital atrophy, and prevention of osteoporosis 1.
- Progesterone is a component of certain FDA-approved combination hormone therapy products, which are indicated for the treatment of moderate to severe vasomotor symptoms, including hot flashes, in postmenopausal women.
- There are no FDA-approved products that contain progesterone as the sole active ingredient for the treatment of hot flashes, as the current indications for use from the U.S. Food and Drug Administration include combination regimens of estrogen and progestin for women with a uterus 1.
- The use of hormone therapy is guided by the U.S. Preventive Services Task Force (USPSTF) recommendations, which were updated after the Women’s Health Initiative (WHI) trials showed important adverse health effects of hormone therapy 1.
Treatment Considerations
- Estrogen alone or combined with progestin is used for the treatment of menopausal symptoms, including hot flashes 1.
- The choice of hormone therapy should be based on the individual patient's needs and medical history, and should be used at the lowest effective dose for the shortest duration consistent with treatment goals 1.
From the Research
FDA Approval for Hot Flash Symptoms
- The FDA has approved paroxetine mesylate for the management of moderate to severe postmenopausal vasomotor symptoms 2, 3.
- There is no evidence to suggest that progesterone alone is FDA-approved for treating hot flash symptoms.
- Non-hormonal treatment options, such as selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs), have been shown to reduce the frequency and severity of hot flashes in menopausal women 4, 3.
Treatment Options for Hot Flash Symptoms
- Paroxetine mesylate is the only non-hormonal treatment that has been approved by the FDA for the management of moderate to severe postmenopausal vasomotor symptoms 2, 3.
- Other treatment options, such as phytoestrogens, have been studied but there is no evidence to suggest that they are effective in alleviating menopausal symptoms 5.
- Hormone replacement therapy is also an option, but it may not be suitable for all women 6.
Key Findings
- The recommended dosage of paroxetine mesylate for the treatment of vasomotor symptoms is 7.5 mg once daily at bedtime 3.
- Side effects of paroxetine mesylate include nausea, fatigue, and dizziness, which are typically dose-dependent 3.
- It is essential to consider potential medication interactions, such as with medications that can lead to serotonin syndrome, when prescribing paroxetine mesylate 3.