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)|
|Abdominal pain||50 (12%)||50 (12%)|
|Nausea||32 (8%)||29 (7%)|
|General Disorders and Administration Site Conditions|
|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|
|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.