Minimal occurrence of abdominal bloating
Similar incidence of abdominal bloating vs placebo in estrogen-primed, postmenopausal women taking PROMETRIUM® 400 mg/day[1]
Low occurrence of emotional instability and irritability
Low incidence of irritability in estrogen-primed, postmenopausal women taking PROMETRIUM® 400 mg/day[1]
The Women’s Health Initiative Memory Study (WHIMS), a substudy of the WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during four years of treatment with oral conjugated estrogens plus medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.[1]
The most common adverse events reported in postmenopausal women receiving PROMETRIUM® 400 mg were: headache, dizziness, breast pain, musculoskeletal pain, and viral infection.[1]
Proven safety profile
Common adverse events[1] (Percentage of patients reporting)
Fewer episodes of excess bleeding*
- Results from the PEPI Trial demonstrated that women on CEE alone had 6 times the number of excess bleeding episodes (n=192) than those taking cyclic PROMETRIUM® plus CEE (n=34) or placebo (n=32).[2]
- Treatment with cyclic MPA plus CEE resulted in 2 times the amount of excess bleeding episodes (n=67) than with cyclic PROMETRIUM® plus CEE or placebo.[2]
- 23% more bleeding days were associated with cyclic MPA during the critical first 6 months of treatment, when adherence patterns were established.[2]
*Excess bleeding was defined as any bleeding for placebo (n=119) and estrogen-only groups (n=119), and greater than 6 bleeding episodes within the 6-month interval for the estrogen + cyclic MP group (n=120) or cyclic MPA (n=118).
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References:
1. PROMETRIUM® [package insert]. Marietta, Ga: Solvay Pharmaceuticals, Inc.; 2004.
2. Lindenfeld EA, Langer RD. Bleeding patterns of the hormone replacement therapies in the Postmenopausal Estrogen and Progestin Interventions Trial. Obstet Gynecol. 2002;100:853-863.
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