Home » Drug Information » FDA Approved Drugs » 1998
Medical Areas: Endocrinology | Obstetrics/Gynecology (Women’s Health)
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved December 1998
Treatment Area: Gynecology
Prometrium Capsules are indicated for use in the prevention of
endometrial hyperplasia in non-hysterectomized postmenopausal women
who are receiving conjugated estrogens tablets. They are also
indicated for use in secondary amenorrhea.
In a randomized double-blind clinical trial, 358 postmenopausal
women, each with an intact uterus, received treatment for up to 36
months. The treatment groups were: Prometrium Capsules at the dose
of 200 mg/day for 12 days per 28 day cycle in combination with
conjugated estrogens 0.625 mg/day (n=120); conjugated estrogens
0.625 mg/day only (n=119); or placebo (n=119). The subjects in all
three treatment groups were primarily Caucasian women (87% or more
of each group). The results for the incidence of endometrial
hyperplasia in women receiving up to 3 years of treatment are
shown. A comparison of the Prometrium Capsules plus conjugated
estrogens treatment group to the conjugated estrogens only group
showed a significantly lower rate of hyperplasia (6% combination
product vs. 64% estrogen alone) in the Prometrium Capsules plus
conjugated estrogens treatment group, throughout 36 months of
Known sensitivity to Prometrium Capsules or its ingredients.
Prometrium Capsules contain peanut oil and should never be used by
patients allergic to peanuts.
SIDE EFFECTS REPORTED IN GREATER THAN OR EQUAL TO 5% OF
PATIENTS AT DOSES OF 100 MG/DAY to 400 MG/DAY:
- Muscle or Bone Pain / Back Pain / Joint Pain
- Chest Pain
- Upper Respiratory Tract Infection / Viral Infection
- Hot Flashes
- Urinary Problems
- Vaginal Discharge / Vaginal Dryness
- Night Sweats
- Abdominal Pain (Cramping)
- Breast Pain / Breast Tenderness
- Nausea / Vomiting
- Irritability / Mood Swings / Depression/ Worry
International Agency for Research on Cancer (IARC) V.6, 1974; IRAC
K.S. Larrson and D. Machin, Safety requirements for contraceptive
steroids. F. Michal (ed.) Cambridge University Press, Cambridge.
Pp. 30-269, 1989.
Sixth Annual Report on Carcinogens V.2, pp 693-696, 1991.
Med. Sci. Res. 1987; 15:703-704