• PROMETRIUM® is micronized (made easier for the body to process) progesterone made exclusively from yam plant sources.[1] PROMETRIUM® is bio-identical to progesterone and can supply a woman’s need for progesterone.[2] The clinical significance 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®.[2]
  
  
• 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.[3]
  
  
• Your healthcare provider may have also prescribed you PROMETRIUM® because you stopped having menstrual periods before menopause (secondary amenorrhea).[2]
  
  
• IF YOU ARE ALLERGIC TO PEANUTS, DO NOT TAKE PROMETRIUM®
  CAPSULES.[2]

What you can 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®.[2]
  
  
• 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.[4]
  
  
• The most common adverse events reported in patients receiving varying dosages of PROMETRIUM® (100 mg/day to 400 mg/day) were: dizziness, breast pain, headache, abdominal pain, chest pain, and diarrhea.[2]
  
  
• If you are pregnant or have any history of abnormal blood clotting, liver disease, undiagnosed abnormal genital bleeding, or breast cancer, you should not take PROMETRIUM®.[2]

Transient dizziness may occur in some patients; they should use caution when driving or operating machinery; for these women, bedtime dosing may be advised.[2]

The most common adverse events reported in postmenopausal women receiving PROMETRIUM® 200 mg were: breast tenderness, dizziness, abdominal bloating, vaginal discharge, chest pain, and diarrhea.[2]

The most common adverse events reported in postmenopausal women receiving PROMETRIUM® 400 mg were: headache, dizziness, breast pain, musculoskeletal pain, and viral infection.[2]

Progesterone with or without estrogens should not be used to prevent heart attacks or heart disease. Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens with progestins may increase your risk of dementia. You and your healthcare provider should talk regularly about whether you still need treatment with PROMETRIUM® Capsules.

References:
1. Data on file, Akzo Nobel letter. 2. PROMETRIUM® package insert. Marietta, Ga: Solvay Pharmaceuticals, Inc.; 2004. 3. 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. 4. Beers MH, Berkow R, eds. The Merck Manual. 17th ed. Whitehouse Station, NJ: Merck Research Laboratories; 1999.