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]
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P<0.001 for 300 mg vs placebo. Subjects had secondary amenorrhea for at least 90 days.
Bleeding response includes bleeders and spotters. |
- 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]
PROMETRIUM® is contraindicated in patients with known or suspected pregnancy.[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]
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]
Next: Protect your patients with bio-identical progesterone
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.; 2004.
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