In a single-center, randomized, double-blind clinical study of premenopausal women (N=60) with secondary amenorrhea, administration of PROMETRIUM® resulted in a greater incidence of withdrawal bleeding within 7 days of last dose than in those subjects taking placebo.[1]

Incidence of withdrawal bleeding for secondary amenorrhea[1]

• Serum progesterone concentrations appear linear
  and dose-proportionate.[2]
• Approved dose for secondary amenorrhea: 400 mg (two 200-mg capsules) at bedtime for 10 days.[2]
• Pregnancy Category B.[2]

Next: Protect your patients with bio-identical progesterone

IMPORTANT SAFETY INFORMATION

Estrogens plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia. The Women’s Health Initiative (WHI) study reported increased risks of stroke, deep vein thrombosis (DVT), pulmonary embolism, myocardial infarction, and invasive breast cancer in postmenopausal women (ages 50–79 years) during 5.6 years of treatment with daily conjugated estrogens 0.625 mg combined with medroxyprogesterone acetate (MPA) 2.5 mg relative to placebo. The WHI Memory Study, an ancillary study of WHI, reported an increased risk of probable dementia in postmenopausal women 65 years of age or older.[2]

PROMETRIUM® is contraindicated for patients with any of the following conditions: known hypersensitivity to its ingredients; 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 (i.e. stroke, myocardial infarction) or a history of these conditions; known liver disease or dysfunction; known or suspected pregnancy.[2]

PROMETRIUM® is contraindicated in patients with known or suspected pregnancy.[2]

Pregnancy Category B

PATIENTS WHO ARE ALLERGIC TO PEANUTS SHOULD NOT USE PROMETRIUM® CAPSULES.[2]

The most common adverse events reported at a rate greater than placebo in a clinical trial by postmenopausal women receiving conjugated estrogens 0.625 mg daily plus cyclic PROMETRIUM® 200 mg capsules were: headache, breast tenderness, depression, dizziness, abdominal bloating, chest pain, and diarrhea.[2]

The most common adverse events reported at a rate greater than placebo in a clinical trial by postmenopausal women receiving PROMETRIUM® 400 mg capsules were: dizziness, abdominal pain, headache, breast pain, musculoskeletal pain, and viral infection.[2]

You are encouraged to report suspected adverse reactions. Please contact Solvay Pharmaceuticals, Inc. at 1-800-241-1643 or the FDA at www.fda.gov/medwatch or by calling 1-800-FDA-1088.

Please click here for the PROMETRIUM® Full Prescribing Information.

References:
1. PROMETRIUM® data on file [Study T91-006 Synopsis and Table B-1]. Solvay Pharmaceuticals, Inc.; 1995. 2. PROMETRIUM® [package insert]. Marietta, Ga: Solvay Pharmaceuticals, Inc.; 2009.