• PROMETRIUM® provides the progesterone your body needs. It is micronized (made easier for the body to process) progesterone made exclusively from yam plant sources. PROMETRIUM® is also bio-identical to progesterone.[1]
  
  However, the clinical significance of this is unknown.
  Click here to see how PROMETRIUM is bio-identical to your body’s own progesterone.
  
  
• Progesterone, like estrogen, is a hormone produced in abundance by the ovaries before a woman goes through menopause. If you are taking estrogen, your healthcare provider may counter some of estrogen’s effect on your uterus by prescribing a progestogen, such as PROMETRIUM®.[1]
  
  
• In a clinical study, PROMETRIUM® given with estrogen therapy protected women from abnormal thickening of the lining of the uterus (hyperplasia) that is associated with estrogen-only therapy. While 62% of women in the study taking estrogen alone had abnormal test results, only 5% of women taking estrogen and PROMETRIUM® together had similar results. Similarly, only 3% of women taking a placebo (neither estrogen nor PROMETRIUM®) had abnormal test results.[2]
  
  
• Your healthcare provider may have also prescribed you PROMETRIUM® because you stopped having menstrual periods before menopause (secondary amenorrhea).[1]
  
  

Who should not take PROMETRIUM® Capsules?

Do not start taking PROMETRIUM® Capsules if you:[1]

• Are allergic to peanuts.
  
  
• Have unusual vaginal bleeding.
  
  
• Currently have or have had certain cancers. Estrogens/progestins may increase the chance of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should take PROMETRIUM® Capsules.
  
  
• Had a stroke or heart attack.
  
  
• Currently have or have had blood clots.
  
  
• Currently have or have had liver problems.
  
  
• Are allergic to any of the ingredients in PROMETRIUM® Capsules. See the list of ingredients in the PROMETRIUM® Patient Information.
  
  
• Think you may be pregnant.

What can you expect when you take PROMETRIUM®?

• If you have stopped having your menstrual cycle prior to menopause (secondary amenorrhea), a clinical study has shown that you may likely have your period within 7 days of taking your last dose of PROMETRIUM®.[1]
  
  
• Some women who take PROMETRIUM® as a part of their hormone therapy (HT) regimen have a menstrual period each month, which may disappear over time. Therefore, you may not have periods while taking PROMETRIUM®. However, the protective effect of progesterone on the uterus is still present.[3]
  

What is the most IMPORTANT SAFETY INFORMATION I should know about PROMETRIUM®?

Estrogens with progestins should not be used to prevent heart disease, heart attacks, strokes, or dementia. Using estrogens with progestins may increase your chance of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens with progestins may increase your chance of getting dementia, based on a study of women age 65 years and older. You and your healthcare professional should talk regularly about whether you still need treatment with PROMETRIUM® Capsules.[1]

Do not take PROMETRIUM® Capsules if you are allergic to peanuts or any of the ingredients in PROMETRIUM®, have unusual vaginal bleeding, currently have or have had certain cancers, had a stroke or heart attack, currently have or have had blood clots, currently have or have had liver problems, or think you may be pregnant.[1]

PATIENTS WHO ARE ALLERGIC TO PEANUTS SHOULD NOT USE PROMETRIUM® CAPSULES.[1]

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.[1]

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.[1]

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 PROMETRIUM® Patient Information.

References:
1. PROMETRIUM® package insert. Marietta, Ga: Solvay Pharmaceuticals, Inc.; 2009. 2. 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. 3. Beers MH, Berkow R, eds. The Merck Manual. 17th ed. Whitehouse Station, NJ: Merck Research Laboratories; 1999.