Skip to main content

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety data reflect exposure to Endometrin in 808 infertile women (74.9% White, 10.3% Hispanic, 5.4% Black, 5% Asian, and 4.6% Other) in a single Assisted Reproductive Technology 10 week clinical study conducted in the U.S. Endometrin was studied at doses of 100 mg twice daily and 100 mg three times daily. The adverse reactions that occurred at a rate greater than or equal to 2% in either Endometrin group are summarized in Table 1.

Table 1: Number and Frequency of Reported Adverse Reactions in Women Treated with Endometrin in an Assisted Reproductive Technology Study

Body System Preferred Term Endometrin 100 mg twice daily (N=404) Endometrin 100 mg three times daily (N=404)
Gastrointestinal Disorders
  Abdominal pain 50 (12%) 50 (12%)
  Nausea 32 (8%) 29 (7%)
  Abdominal distension 18(4%) 17(4%)
  Constipation 9(2%) 14 (3%)
  Vomiting 13(3%) 9(2%)
General Disorders and Administration Site Conditions
  Fatigue 7(2%) 12 (3%)
Infections and Infestations
  Urinary tract infection 9(2%) 4 (1%)
Injury, Poisoning and Procedural Complications
  Post-ooctye retrieval pain 115(28%) 102 (25%)
Nervous System Disorders
  Headache 15(4%) 13(3%)
Reproductive System and Breast Disorders
  Ovarian hyperstimulation syndrome 30 (7%) 27 (7%)
  Uterine spasm 15(4%) 11 (3%)
  Vaginal bleeding 13(3%) 14 (3%)

Other less common reported adverse reactions included vaginal irritation, itching, burning, discomfort, urticaria, and peripheral edema.

Expected Adverse Reaction Profile Seen with Progesterone

Endometrin is also expected to have adverse reactions similar to other drugs containing progesterone that may include breast tenderness, bloating, mood swings, irritability, and drowsiness.