Brand Name: Plan B
Active Ingredient: levonorgestrel
Indication: Emergency contraception
Dosage Form(s): 0.75mg tablets
Company Name: Women’s Capital Corporation
Plan B (levonorgestrel), a progestin-only emergency contraceptive regimen, is the first drug specifically designed as emergency contraceptive to receive FDA approval. The only other approved emergency contraception regimen is Preven. Preven, marketed by Gynetics, follows the Yuzpe regimen, which contains two 0.25 mg levonorgestrel tablets and one 0.05 mg ethinyl estradiol tablet.
The Women’s Capital Corporation (WCC), a privately owned company, was organized in 1997 exclusively to develop and launch Plan B (levonorgestrel). Initially, the regimen will be available by prescription through Planned Parenthood agencies. The product will be nationally accessible by the end of 1999.
How It Works
Plan B (levonorgestrel) prevents pregnancy by modifying the tubal transport of sperm and/or ova, hence affecting ovulation or fertilization. It is also capable of inhibiting implantation by altering the endometrium (the inner mucous membrane of the uterus).
Plan B (levonorgestrel): Clinical Study Results
A double-blind, controlled clinical trial was conducted that included 1955 women. The study compared the safety and efficacy of Plan B to the Yuzpe regimen. Plan B (levonorgestrel) reduced the pregnancy rate of 8% after one act of unprotected intercourse to 1.1%; whereas, the pregnancy rate among Yuzpe patients was reduced to 3.2%.
Comparing the number of expected pregnancies without treatment to the number of that occurred pregnancies with treatment demonstrated that Plan B and Yuzpehelped reduce the number of pregnancies by 85% and 57%, respectively. Incidents of nausea and vomiting were greatly reduced among Plan B patients. A significantly lower percentage of women who received Plan B (levonorgestrel) experienced nausea (23.1% vs. 50.5%) and vomiting (5.6% vs. 18.8%) compared to Yuzpe patients (p < 0.01). The efficacy of both regimens significantly (p = 0.01) reduced with increasing time since unprotected intercourse.
What the Patient Should Know
Plan B (levonorgestrel) is not recommended for use as a routine form of contraceptive, nor is it effective in terminating an existing pregnancy. Like all other oral forms of contraception, Plan B (levonorgestrel) does not protect against HIV/AIDS or other sexually transmitted diseases. It is possible to experience spotting a few days after treatment or abnormal bleeding during the patient’s period.
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