News flash: Add new 25-mcg Cyclessa to triphasic oral contraceptive options
Pill represents lowest estrogen dose in a triphasic pill available in U.S.
When reviewing the choices in triphasic oral contraceptives (OCs), providers now can add another option: Cyclessa from Organon of West Orange, NJ. The pill represents the lowest estrogen dose available in a triphasic pill.
Cyclessa consists of 25 mcg of ethinyl estradiol (EE) per day for 21 days. The daily progestin dose is 100 mcg of desogestrel for days 1-7, 125 mcg for days 8-14, and 150 mcg for days 15-21. The last seven pills in the 28-day blister package are placebo pills.
"The 25-mcg ethinyl estradiol with desogestrel pill is a low-dose triphasic oral contraceptive that offers women yet another choice of oral contraceptives," says Sharon Schnare, RN, FNP, CNM, MSN, women’s health consultant and clinician with the Seattle King County Health Department in women’s and adolescent health care and the International District Com-munity Health Center in Seattle. "With current studies showing low-dose oral contraceptives having similar health benefits as higher-estrogen dose pills, this offers a lower-dose option pill for women."1
While Organon received Food and Drug Administration approval for Cyclessa in December 2000, it chose to make its announcement during
the June 2001 consumer launch to coincide with the stocking of Cyclessa on retail pharmacy shelves, says Nancy Alexander, PhD, director of contraception at Organon. The delay in announcement allowed the company to ensure that Cyclessa is covered by many health insurance plans, she states. Cost of the new pill is comparable to other currently marketed brands, says Alexander.
Add to triphasic list
Cyclessa is making its first appearance in the United States and is not yet available in other countries, confirms Alexander. It joins the following U.S.-marketed triphasic pills: Triphasil (Wyeth-Ayerst Laboratories, Philadelphia), Tri-Levelen (Berlex Laboratories, Montville, NJ), Trivora and Tri-Norinyl (Watson Laboratories, Corona, CA), Ortho-Novum 7/7/7 and Ortho Tri-Cyclen (Ortho-McNeil Pharmaceuticals, Raritan, NJ). Estrostep (Parke-Davis, Morris Plains, NJ) uses a triphasic dose of EE (20, 30, and 35 mcg) with a steady 1 mg dose of the progestin norethindrone acetate.
Ortho Tri-Cyclen, Ortho-Novum 7/7/7, and Tri-Norinyl contain 35 mcg of EE, with Triphasil, Tri-Levelen, and Trivora formulated with a 30 mcg EE dose. The progestins in the triphasic list include norgestimate (Ortho Tri-Cyclen), levonorgestrel (Triphasil, Tri-Levelen, Trivora), and norethindrone acetate (Ortho-Novum 7/7/7, Tri-Norinyl).
A potential advantage of triphasic OCs is the lowering of overall monthly progestin dose while maintaining contraceptive efficacy and reducing cycle control problems such as breakthrough bleeding/spotting, says Andrew Kaunitz, MD, professor and assistant chair in the obstetrics
and gynecology department at the University
of Florida Health Science Center/Jacksonville. Kaunitz authored the report of the contraceptive safety and efficacy trial for Cyclessa.2
"The availability of a reduced estrogen-dose pill with excellent cycle control represents a positive new oral contraceptive choice," states Kaunitz.
For women whose providers wish to prescribe a triphasic pill, Cyclessa’s lower dose of estrogen makes it a suitable choice for both first-start patients and those switching from other pills, says Alexander. The pill joins Organon’s other two OCs, Desogen and Mircette, which also use EE and desogestrel in their formulations.
Review research results
Two identical multicenter, open-label, randomized, parallel group, comparative Phase III six-cycle trials were used to analyze the contraceptive efficacy, cycle control, and safety of Cyclessa. The trials compared Cyclessa against another triphasic, Ortho-Novum 7/7/7.
A total of 5,654 women were enrolled in both controlled trials. Early discontinuation rates (18.4%) were identical for the Cyclessa and Ortho-Novum 7/7/7 group.
In these two trials, which involved a total of 29,130 cycles of exposure, the contraceptive efficacy of Cyclessa was equivalent to that of Ortho-Novum 7/7/7, according to the researchers.
Four pregnancies were reported in the group of 2,353 women who took Cyclessa during all six cycles with proper compliance and used no backup method; eight pregnancies were recorded in the 2,393 women who took Ortho-Novum 7/7/7. The Pearl Index was 0.51 for the Cyclessa group and 1.00 for the Ortho-Novum group, a difference that was not statistically significant. The six-cycle life table cumulative pregnancy rate for Cyclessa was estimated as 0.0051; for Ortho-Novum 7/7/7, it was 0.0039.
Cycle control a plus
In the clinical trial, Cyclessa users reported less breakthrough bleeding and spotting than women who used Ortho-Novum 7/7/7. For each of the months of the study, the incidence of breakthrough bleeding/spotting was lower in the Cyclessa group than the Ortho-Novum 7/7/7 group.
Generally, the incidences of breakthrough bleeding and spotting are reported to increase with lower estrogen doses; however, Cyclessa provided improved cycle control in comparison with Ortho-Novum 7/7/7, states Kaunitz in the clinical trial report.
There was significantly less weight gain and less increase in body mass index in the Cyclessa group, according to the clinical trial findings.
Michael Rosenberg, MD, MPH, clinical professor of obstetrics and gynecology at the school of medicine and adjunct professor of epidemiology at the school of public health at the University of North Carolina at Chapel Hill, says, "As we reduce the dose of estrogen, the question is the balance between cycle control and estrogenic symptoms, from a user perspective. Both of these are among the most common side effects and directly related to user satisfaction and continuation rates." Rosenberg is president of Health Decisions, a Chapel Hill private research firm specializing in reproductive health.
A randomized, open-label multicenter clinical trial compared Alesse (a 20-mcg EE/levonorgestrel pill from Wyeth-Ayerst Laboratories), Mircette (a 20-mcg EE/desogestrel pill from Organon) and Ortho Tri-Cyclen (a 35-mcg EE/norgestimate pill).3 Bloating, breast tenderness, and nausea were approximately 50% more common in women using the 35-mcg pill compared to those taking the 20-mcg pills. Cycle control was similar in all products, although during the first two cycles among starters, users of Mircette and Ortho Tri-Cyclen exhibited better cycle control than Alesse users.
The movement toward lower estrogen-containing OCs places renewed emphasis on proper use of OCs — taking a pill every day, preferably at the same time — and on the need for proper counseling to that effect, states Rosenberg.
References
1. Poindexter A. The emerging use of the 20-microg oral contraceptive. Fertil Steril 2001; 75:457-465.
2. Kaunitz AM. Efficacy, cycle control, and safety of two triphasic oral contraceptives: Cyclessa (triphasic desogestrel/ethinyl estradiol) and Ortho Novum 7/7/7 (norethindrone/ethinyl estradiol): A randomized clinical trial. Contraception 2000; 61:295-302.
3. Rosenberg MJ, Meyers A, Roy V. Efficacy, cycle control, and side effects of low- and lower-dose oral contraceptives: A randomized trial of 20 micrograms and 35 micrograms estrogen preparations. Contraception 1999; 60:321-329.
For more information on Cyclessa, contact:
• Organon, 375 Mount Pleasant Ave., West Orange, NJ 07052. Telephone: (800) 241-8812 or (973) 325-4729. Web: www.organoninc.com.
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