The injection s must be administered by a health care provider. Lunelle was developed as an alternative to another injectable contraceptive called Depo-Provera that lasts three months. Like many birth control pills, it works through a combination of the hormones progestin and estrogen. Lunelle was approved based on data from a clinical study of 1,103 women at 42 sites in the United States. The 783 women taking Lunelle had no unintended pregnancies, though there were two among the 321 women using the oral contraceptive after 15 cycles of use.
Women taking the contraceptive injection still have monthly menstrual cycles.
There also is a quick return to ovulation, usually within two to four months post cessation of use. A pre-IND meeting is scheduled for the first week in October. Each week, highlights of what is going on at FDA are shared to assure that new information is expeditiously made available. Dr. Kelsey has long been honored for her role in blocking approval of the drug thalidomide in the l960's. Her refusal to approve thalidomide for use in the U.S. earned her national recognition and her work led to strengthened regulation of the pharmaceutical industry.