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Home » Drug Information » FDA Approved Drugs » 1998
Medical Areas: Endocrinology | Obstetrics/Gynecology (Women’s Health)

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Prometrium

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Schering-Plough
Approval Status: Approved December 1998
Treatment Area: Gynecology

General Information

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.

Clinical Results

Endometrial Protection:

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 treatment.

Side Effects

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:

  • Dizziness
  • Headache
  • Muscle or Bone Pain / Back Pain / Joint Pain
  • Fatigue
  • Diarrhea
  • Chest Pain
  • Coughing
  • Upper Respiratory Tract Infection / Viral Infection
  • Hot Flashes
  • Urinary Problems
  • Vaginal Discharge / Vaginal Dryness
  • Night Sweats
  • Abdominal Pain (Cramping)
  • Breast Pain / Breast Tenderness
  • Bloating
  • Nausea / Vomiting
  • Irritability / Mood Swings / Depression/ Worry

Literature References

1.
International Agency for Research on Cancer (IARC) V.6, 1974; IRAC V.21, 1979.

2.
K.S. Larrson and D. Machin, Safety requirements for contraceptive steroids. F. Michal (ed.) Cambridge University Press, Cambridge. Pp. 30-269, 1989.

3.
Sixth Annual Report on Carcinogens V.2, pp 693-696, 1991.

4.
Med. Sci. Res. 1987; 15:703-704