Berlex introduces new 20 mcg birth control pill

Add another 20 mcg oral contraceptive (OC) to the list of low-dose pills: Levlite from Berlex Laboratories of Wayne, NJ. The new OC, which received federal Food and Drug Administration approval in August, should be on pharmacy shelves in this month, reports Berlex senior product manager Ellen Schoenberger.

The pill is the first OC from Berlex, the U.S. pharmaceutical affiliate of Berlin, Germany-based Schering AG, since the mid-1980s debut of Tri-Levlen, says Peter Boerrigter, MD, Berlex senior associate director of clinical research, endocrinology, and fertility control. The Levlite introduction marks the first of a new series of products in the Berlex pipeline, with more to come, he says.

Levlite, which contains 20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel, joins Alesse, a similar formulation manufactured by Wyeth-Ayerst of Philadelphia. (For complete information on Alesse, see Contraceptive Technology Update, August 1997, p. 93.) Until August 1997, the 20 mcg spot was held by Loestrin 1/20, a 20 mcg pill manufactured by Parke-Davis of Morris Plains, NJ. Loestrin 1/20 differs from Levlite and Alesse in its progestin, a 1 mg formulation of norethindrone acetate.

While Mircette, a new OC introduced earlier this year by Organon of West Orange, NJ, also contains 20 mcg of ethinyl estradiol, it differs in both its dosing regimen and progestin. The pill relies on 21 days of 20 mcg of ethinyl estradiol and 150 mcg of the progestin desogestrel, followed by two days of placebo pills, and completed by five days of 10 mcg pills of ethinyl estradiol. (For more on Mircette, see CTU, July 1998, p. 85.)

According to Contraceptive Technology (CT), the low-dose pills provide a woman with 33.3% less ethinyl estradiol than in a 30 mcg pill and 43% less estrogen than in all the 35 mcg OCs. CT reminds clinicians that there are two potential problems with any of these 20 mcg pills: spotting and a smaller margin of error for missed pills.1

"The major reason for bringing out our low-dose OC is that we discovered with lower hormonal exposure to women, you can achieve the same efficacy," notes Boerrigter. "Hopefully, you also will be able to reduce the subjective complaints people may have about using the pill."

Eighteen centers participated in the U.S. trial of Levlite, with 755 women enrolled in the study, Boerrigter confirms. This database has been merged with that of a similar German study,2 with results scheduled for publication in the near future. He says the U.S. results are in line with those found in the German study.

In the German trial, data from 805 treated women resulted in 4,400 treatment cycles. One pregnancy occurred during the trial as a result of method failure, resulting in a Pearl index of 0.29.

Spotting, alone or in combination with breakthrough bleeding, was reported in 13.8% of cycles, and breakthrough bleeding alone or combination with spotting was reported in 5.9% of cycles, the German researchers found. Throughout the treatment period, 81.7% of cycles were free from any irregular bleeding.

Dysmenorrhea decreased considerably during treatment, with nearly all women who had reported severe symptoms in the first treatment cycle experiencing improvement. A total of 86 of the 134 women who had mild dysmenorrhea in the first cycle reported no such effect in the last treatment cycle.

Headache, breast tenderness, and nausea were the most common side effects in the overseas trial, reported by 17.3%, 11%, and 7.7% of women, respectively. A total of 8.4% of women discontinued due to adverse events, which were noted as intermenstrual bleeding (33 cases), nausea (seven cases), and weight gain (seven cases.)

The major side effect noted in the U.S. trial was headache, a common side effect of low-dose pills, says Boerrigter. "Breast tenderness and nausea are typically symptoms that occur mostly in the beginning of pill taking. If you follow them over time, you will see a reduction to less than half of the original complaints in the cycle. It is a matter of adjustment of the body’s system to the new pill."

More clinicians are moving toward the low-dose pills, says Michael Rosenberg, MD, MPH, clinical professor of OB/GYN and epidemiology at the University of North Carolina and president of Health Decisions, a private research firm, both in Chapel Hill. Rosenberg is conducting studies of clinicians’ usage of the 20 mcg pills.

"I think the market has been moving toward the low dose," agrees Schoenberger. "They provide the same efficacy as the higher-dose pills, so it makes sense to lower the dose."

References

1. Hatcher RA, Trussell J, Stewart F, et al. Contraceptive Technology. 17th ed. New York City: Ardent Media; 1998.

2. Bannemerschult R, Hanker JP, Wunsch C, et al. A multicenter, uncontrolled clinical investigation of the contraceptive efficacy, cycle control, and safety of a new low dose oral contraceptive containing 20 micrograms ethinyl estradiol and 100 micrograms levonorgestrel over six treatment cycles. Contraception 1997; 56:285-290.

Resource

For more information on Levlite, contact:

Berlex Laboratories, 300 Fairfield Road, Wayne, NJ 07470-7358. Telephone: (888) BERLEX-4 or (201) 694-4100. Fax: (201) 942-1610.