Effective endometrial protection was proven in the PEPI* Trial, an NIH-sponsored, independent, 3-year, multicenter, randomized, double-blind, placebo-controlled study of healthy postmenopausal women with an intact uterus (N=596) aged 45 to 64 years.[1]

Protect the endometrium from hyperplastic changes associated with estrogen-only therapy[1]

Estrogen combined with cyclic micronized progesterone:

• Resulted in no statistical difference in the occurrence of abnormal endometrial biopsy compared to placebo (P=0.16).[1]
  

Normal endometrial biopsy results over 36 months[1]


*Postmenopausal Estrogen/Progestin Interventions Trial.
†Statistically significant at P<0.001 vs estrogen alone.
‡P=0.16 vs placebo.

Active regimens contained conjugated equine estrogens (CEE) (0.625 mg/day) alone or in combination with continuous medroxyprogesterone acetate (MPA)
(2.5 mg/day), cyclic MPA (10 mg/day for 12 days/cycle), or cyclic PROMETRIUM® (200 mg/day for 12 days/cycle).

Next: Proven effective treatment for secondary amenorrhea

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. The Writing Group for the PEPI Trial. Effects of hormone replacement therapy on endometrial histology in postmenopausal women: the Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial. JAMA. 1996;275:370-375. 2. PROMETRIUM® [package insert]. Marietta, Ga: Solvay Pharmaceuticals, Inc.; 2009.