What are the uses of Prometrium (progesterone)?

From the Guidelines

Prometrium is primarily used to treat hormone imbalances in women, including conditions such as amenorrhea, abnormal uterine bleeding, and to provide endometrial protection for women taking estrogen during menopause, with typical dosages ranging from 100-400 mg daily. The medication works by mimicking natural progesterone, which helps regulate the menstrual cycle, supports pregnancy, and counterbalances estrogen's effects on the uterine lining 1. Some of the key uses of Prometrium include:

• Treating amenorrhea (absence of menstrual periods) with a typical dosage of 400 mg daily taken at bedtime for 10 days to induce menstrual bleeding
• Providing endometrial protection for women taking estrogen during menopause, typically at doses of 100-200 mg daily for 12-14 days per month
• Helping maintain early pregnancy in women with a history of recurrent miscarriage due to luteal phase defects, typically at doses of 200-400 mg daily
• Supporting pregnancy and reducing the risk of preterm birth in women with a short cervix, as evidenced by studies such as 1, which found that vaginal progesterone reduced the likelihood of preterm birth in asymptomatic individuals with a singleton gestation and a transvaginal cervical length of ≤20 mm. Common side effects of Prometrium include drowsiness, dizziness, and breast tenderness, which is why it's often recommended to take it at bedtime 1. Unlike synthetic progestins, Prometrium has a molecular structure identical to the body's natural progesterone, potentially offering a more favorable side effect profile for some women 1. It's worth noting that the use of progestogens, including Prometrium, in certain populations, such as women with multiple gestations or a history of preterm labor, is not universally recommended and should be considered on a case-by-case basis, as evidenced by studies such as 1 and 1.

From the FDA Drug Label

What is Progesterone Capsules used for? Treatment of Menstrual Irregularities Progesterone Capsules are used for the treatment of secondary amenorrhea (absence of menstrual periods in women who have previously had a menstrual period) due to a decrease in progesterone Protection of the Endometrium (Lining of the Uterus) Progesterone Capsules are used in combination with estrogen-containing medications in a postmenopausal woman with a uterus (womb).

The uses of Prometrium (progesterone) are:

• Treatment of menstrual irregularities: secondary amenorrhea due to a decrease in progesterone.
• Protection of the endometrium: used in combination with estrogen-containing medications in postmenopausal women with a uterus to reduce the chance of getting cancer of the uterus. 2

From the Research

Uses of Prometrium (Progesterone)

• Prometrium, a form of progesterone, is used to prevent miscarriage in women with recurrent miscarriage of unclear etiology 3, 4, 5, 6.
• It is also used to support pregnancy and prevent spontaneous miscarriage in women with a history of recurrent miscarriage 5, 6.
• Additionally, Prometrium may be used to treat women with threatened miscarriage, although the evidence for its effectiveness in this context is limited 4, 7.
• The medication is typically administered in the first trimester of pregnancy, and the route, dosage, and duration of treatment may vary depending on the specific clinical scenario 3, 4, 5, 6.

Benefits and Risks

• The use of Prometrium to prevent miscarriage in women with recurrent miscarriage may reduce the risk of miscarriage and increase the live birth rate 3, 6, 7.
• However, the evidence for its effectiveness in women with threatened miscarriage is less clear, and more research is needed to fully understand its benefits and risks in this context 4, 7.
• The medication is generally well-tolerated, but it may cause side effects such as dizziness, drowsiness, and breast tenderness 3, 4, 5, 6.
• Women with a history of miscarriage who present with bleeding in early pregnancy may benefit from the use of Prometrium, and the decision to use the medication should be made in consultation with a healthcare provider 7.

Clinical Evidence

• Several studies have investigated the use of Prometrium to prevent miscarriage, including the PROMISE and PRISM trials, which found that the medication may increase the live birth rate in women with recurrent miscarriage 7.
• A Cochrane review of 12 trials found that progestogen supplementation, including Prometrium, may reduce the risk of miscarriage in women with recurrent miscarriage 6.
• Another Cochrane review of 9 trials found that progestogen supplementation, including Prometrium, probably makes little or no difference in the miscarriage rate for women with recurrent miscarriage, but may increase the live birth rate 3.