Progesterone

Progesterone is a female sex hormone produced mainly in the ovaries after ovulation, with smaller amounts made by the adrenal glands and during pregnancy by the placenta. It supports the menstrual cycle, fertility, and early pregnancy, and it also affects mood, sleep, and heart and bone health.

Medically, progesterone is available in several forms, including oral capsules, vaginal gels or suppositories, and injectables. It’s commonly prescribed as part of hormone replacement therapy (HRT) for menopausal women, often in combination with estrogen. Progesterone is also used in fertility treatments, to help regulate menstrual irregularities, and to support pregnancy in women with certain hormonal deficiencies.

While generally well tolerated, progesterone can cause side effects such as breast tenderness, bloating, mood changes, fatigue, and headaches. In some cases, higher doses may increase the risk of blood clots or other complications, especially when combined with estrogen therapy. Progesterone should be used under medical supervision, with dosing tailored to a person’s needs and medical history.

Progesterone is indicated for:

• Use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets

• Secondary amenorrhea

Progestogen

Less serious but common side effects include:

• Headaches

• Breast pain

• Irregular vaginal bleeding or spotting

• Stomach/abdominal cramps, bloating

• Nausea and vomiting

• Hair loss

• Fluid retention

• Vaginal yeast infection

The cost of progesterone varies depending on the dosage, form, brand, where you buy it, and your insurance coverage. Generic oral and injectable progesterone may cost between $20 and $40 per month, while brand-name vaginal progesterone may cost between $300 and $400. Health insurance may cover all or some of the cost of progesterone.

• Progesterone capsules should not be used in patients with known hypersensitivity to its ingredients. Progesterone capsules contain peanut oil and should never be used by patients allergic to peanuts

• Undiagnosed abnormal genital bleeding

• Known, suspected, or history of breast cancer

• Active deep vein thrombosis, pulmonary embolism or history of these conditions

• Active arterial thromboembolic disease (for example, stroke and myocardial infarction), or a history of these conditions

• Known liver dysfunction or disease

• Known or suspected pregnancy

• Drug interactions: Ketoconazole and other known inhibitors of cytochrome P450 3A4 may increase the bioavailability of progesterone

• An increased risk of pulmonary embolism, deep vein thrombosis (DVT), stroke, and myocardial infarction has been reported with estrogen plus progestin therapy

• Malignant neoplasms, including breast cancer, endometrial cancer, and ovarian cancer

• Probable dementia

• Vision abnormalities

• Fluid retention

• Dizziness and drowsiness

• This product contains peanut oil and should not be used if you are allergic to peanuts

• Some lab results may be altered by the use of estrogen plus progestin therapy

• Pregnancy: Progesterone capsules should not be used during pregnancy

• Breastfeeding: Detectable amounts of progestin have been identified in the milk of nursing women receiving progestins. Caution should be exercised when progesterone capsules are administered to a nursing woman

WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA FOR ESTROGEN PLUS PROGESTIN THERAPY

Cardiovascular Disorders and Probable Dementia

Estrogens plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia.

The Women's Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of deep vein thrombosis, pulmonary embolism, stroke and myocardial infarction in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo.

The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.

Breast Cancer

The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer.

In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA, and other combinations and dosage forms of estrogens and progestins.

Progestins with estrogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

*This information is from progesterone label used by Bionpharma Inc. See the Full Prescribing Information for more complete information. This information may not be accurate for all medications that include progesterone.