From the Guidelines
Progesterone FDA Approval for Hot Flash Symptoms
Progesterone is FDA-approved for the treatment of moderate to severe vasomotor symptoms, including hot flashes, associated with menopause, as part of hormone therapy [ 1 ].
- Specifically, progesterone capsules are indicated for this use, with a recommended dose that should be individualized based on risks and the lowest dose possible to control symptoms.
- Combination products, such as those including estrogen and progestin, are also FDA-approved for the treatment of moderate to severe hot flashes, with the choice of formulation (e.g., oral, transdermal) and specific components (e.g., type of estrogen, progestin) depending on patient factors and history [ 1 ].
- Micronized progestin may be preferred over medroxyprogesterone acetate due to lower rates of venous thromboembolism and breast cancer risk [ 1 ].
- It's crucial to consider the patient's medical history, including any history of hormonally mediated cancers, thromboembolic events, or other conditions that may contraindicate the use of hormone therapy [ 1 ].
From the FDA Drug Label
TABLE 6 lists adverse reactions greater than or equal to 2 percent of women who received cyclic progesterone capsules 200 mg daily (12 days per calendar month cycle) with 0. 625 mg conjugated estrogens or placebo. ... Hot Flashes 11 35
The FDA drug label does not explicitly state that progesterone is approved for treating hot flash symptoms, but it does report the incidence of hot flashes in patients receiving progesterone capsules. Key points:
- The label reports hot flashes as an adverse reaction.
- The incidence of hot flashes is lower in the progesterone group (11%) compared to the placebo group (35%). However, this information is not sufficient to conclude that progesterone is FDA-approved for treating hot flash symptoms 2.
From the Research
FDA Approval for Progesterone in Treating Hot Flash Symptoms
- The FDA has approved hormone therapy for the treatment of hot flashes, which includes progesterone 3.
- A specific formulation of bioidentical 17β-estradiol and progesterone in a single capsule, known as Bijuva, was FDA-approved in October 2018 for the treatment of moderate to severe vasomotor symptoms due to menopause 4.
- However, it is essential to note that not all progesterone formulations or combinations are FDA-approved for this specific use.
- Other treatments, such as paroxetine mesylate, have been approved by the FDA for the management of moderate to severe postmenopausal vasomotor symptoms, but these are non-hormonal options 5.
Key Considerations
- The effectiveness and safety of progesterone for treating hot flash symptoms can depend on various factors, including the specific formulation, dosage, and individual patient characteristics.
- Recent studies have investigated the efficacy and safety of various treatments for vasomotor symptoms, including fezolinetant, which has shown promise in reducing VMS frequency and severity 6.
- Hormone therapy, including progesterone, should be considered in the context of individual patient needs and risk factors, taking into account the timing of initiation, type and route of administration, and patient-specific considerations 7.