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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
|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%)|
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.
Read the Endometrin (progesterone) Side Effects Center for a complete guide to possible side effects
No formal drug-drug interaction studies have been conducted for Endometrin. Drugs known to induce the hepatic cytochrome-P450-3A4 system (such as rifampin, carbamazepine) may increase the elimination of progesterone. The effect of concomitant vaginal products on the exposure of progesterone from Endometrin has not been assessed. Endometrin is not recommended for use with other vaginal products (such as antifungal products) as this may alter progesterone release and absorption from the vaginal insert [see WARNINGS AND PRECAUTIONS].
Read the Endometrin Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 4/22/2013
Additional Endometrin Information
Endometrin - User Reviews
Endometrin User Reviews
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Report Problems to the Food and Drug Administration
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