Levonorgestrel and Ethinyl Estradiol Birth Control Pills Reviews

April 17, 2022 Post a Comment

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New Drug Reviews

Levonorgestrel/Ethinyl Estradiol (Lybrel) for Continuous Contraception

LISA McCARTHY, PharmD, Leslie Dan Kinesthesia of Phamacy, University of Toronto, Toronto, Ontario, Canada

Am Fam Dr.. 2008 Jan xv;77(2):222-225.

Each tablet of Lybrel is composed of 90 mcg of levonorgestrel and twenty mcg of ethinyl estradiol. It is labeled for use every bit a continuous-cycle oral contraceptive. There is no physiologic reason for cyclic employ of monophasic oral contraceptives, and research has demonstrated the safe and effectiveness of other estrogen/progestin combinations.ane

Proper name	Starting dosage	Dose course	Approximate monthly cost*
Levonorgestrel/ethinyl estradiol (Lybrel)	i tablet daily	Tablet containing 90 mcg of levonorgestrel and 20 mcg of ethinyl estradiol	$54

Rubber

Levonorgestrel and ethinyl estradiol are used in several other combination products that accept demonstrated long-term prophylactic. Rubber of the continuous use of combined hormonal contraceptives has non been followed across ii years. Even so, if at that place are greater safety risks associated with long-term use of extended or continuous-bicycle combined hormonal contraceptives than with cyclic contraceptives, they are likely minimal.2

Cautions and contraindications of Lybrel are similar to those of other combined oral contraceptives. It is contraindicated for patients with a history of thromboembolic disorder, undiagnosed vaginal haemorrhage, active liver illness, or uncontrolled hypertension.3 In that location besides is an increased hazard of thrombosis; smoking increases this gamble, particularly in women older than 35 years.3 In a 12-month phase 3 report, two cases of deep venous thrombosis and 1 case of pulmonary embolism were reported in 2,134 patients taking Lybrel.4

As with other oral contraceptives, Lybrel does non protect against sexually transmitted infections,3 and use during pregnancy is contraindicated because the production volition be ineffective. Exposure to other combined oral contraceptives has non been shown to increment the gamble of fetal malformations.5,6 Use during lactation is non recommended for the first half-dozen weeks postpartum; after this time, it is considered safety, but it may affect the quantity of breast milk because of the ethinyl estradiol component.7,8

On abeyance of Lybrel, 38.5 percent of women experienced return to menses or pregnancy within 30 days, and 99 pct experienced this inside 90 days.ix

TOLERABILITY

Studies accept found that extended or continuous-cycle combined hormonal oral contraceptive regimens have fewer bleeding days than cyclic regimens; however, there is no difference in the number of spotting days.1,x,11 Patients should be advised that they will likely feel unpredictable bleeding (spotting or more), which will gradually subtract with time. In the largest study to date, after 12 months of continuous use, lx percent of patients were amenorrheic and 79 percent reported an absence of bleeding (i.e., did not require the employ of feminine hygiene products) but may have still experienced spotting. Seventeen percent of patients discontinued therapy because of adverse furnishings, with 1 one-half attributing discontinuation to unexpected uterine bleeding.4

It tin can be determined from the limited published data that tolerability of Lybrel is similar to that of other combined oral contraceptives. The most common adverse effects include headache, dysmenorrhea, abdominal pain, and back hurting.four Continuous-wheel combined oral contraceptives take also been associated with decreased rates of headache, genital itch, bloating, and menstrual hurting compared with circadian regimens; however, some studies take shown no difference.one

EFFECTIVENESS

The effectiveness of Lybrel is likely similar to that of other continuous-bike combined oral contraceptives, which are every bit constructive equally cyclic regimens in preventing pregnancy.1,ten–12 Based on Due north American data, 2.38 per 100 typical women taking Lybrel for one year will become unintentionally pregnant, which is a rate similar to that of other combined oral contraceptives.3,13 Perfect users will have a lower charge per unit of pregnancy (well-nigh 1.sixty pregnancies per 100 women per twelvemonth).four As with all medications, it is reasonable to expect that effectiveness outside a structured clinical trial setting will exist less than that observed in studies. Continuous-cycle combined oral contraception is also useful for decreasing dysmenorrhea in patients with endometriosis.14,fifteen

PRICE

Lybrel costs approximately $54 per month. Alesse and Desogen, which are combined oral contraceptives that can be taken continuously, cost approximately $38 and $44 per month, respectively.

SIMPLICITY

Lybrel is taken at the aforementioned time each day, continuously without a 7-day break.three Most women will proceed to experience menstrual bleeding for the first several months; even so, it may exist less predictable than information technology is with other circadian combined oral contraceptive regimens. Women should expect menstrual bleeding at any time and need to be counseled about this possibility.

Bottom Line

Lybrel appears to exist every bit safe and constructive every bit other combined oral contraceptives; however, at this time, there is little published data nearly this specific production. Other combined monophasic oral contraceptives, some of which cost less than Lybrel, can exist used continuously and accept been shown to produce like results. Patients who cull to take contraceptives continuously should be advised that they may experience spotting or irregular menses at whatever time.

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Address correspondence to Lisa McCarthy, PharmD, at lmccart@mcmaster.ca. Reprints are not available from the authors.

Author disclosure: Nix to disclose.

REFERENCES

show all references

1. Edelman AB, Gallo MF, Jensen JT, Nichols MD, Schulz KF, Grimes DA. Continuous or extended bike versus circadian use of combined oral contraceptives for contraception. Cochrane Database Syst Rev. 2005;three:CD004695. ...

2. Guilbert E, Boroditsky R, Blackness A, et al., for the Social club of Obstetricians and Gynecologists of Canada. Canadian consensus guideline on continuous and extended hormonal contraception, 2007. J Obstet Gynaecol Can. 2007;29(7 suppl ii):S1–32.

3. Lybrel (ninety mcg levonorgestrel and twenty mcg ethinyl estradiol) tablets [Product information]. Philadelphia, Pa.: Wyeth Pharmaceuticals, Inc. http://www.wyeth.com/content/showlabeling.asp?id=489. Accessed September 24, 2007.

4. Archer DF, Jensen JT, Johnson JV, Borisute H, Grubb GS, Constantine GD. Evaluation of a continuous regimen of levonorgestrel/ethinyl estradiol: phase iii study results. Contraception. 2006;74(6):439–445.

five. Lammer EJ, Cordero JF. Exogenous sex hormone exposure and the run a risk for major malformations. JAMA. 1986;255(22):3128–3132.

6. Raman-Wilms Fifty, Tseng AL, Wighardt S, Einarson TR, Koren G. Fetal genital effects of beginning-trimester sex hormone exposure: a meta-assay. Obstet Gynecol. 1995;85(1):141–149.

7. Kelsey JJ. Hormonal contraception and lactation. J Hum Lact. 1996;12(iv):315–318.

8. Contraceptives, oral, combined. Record No. 422. Bethesda, Md.: U.S. National Library of Medicine. http://toxnet.nlm.nih.gov/. Accessed September 24, 2007.

nine. Davis AR, Kroll R, Soltes B, Haudiquet V, Constantine G, Grubb K. Render to menses later on continuous employ of a low-dose oral contraceptive. Obstet Gynecol. 2006;107(4 suppl):3S.

10. Miller 50, Notter KM. Menstrual reduction with extended use of combination oral contraceptive pills: randomized controlled trial. Obstet Gynecol. 2001;98(5 pt 1):771–778.

11. Kwiecien M, Edelman A, Nichols Md, Jensen JT. Haemorrhage patterns and patient acceptability of standard or continuous dosing regimens of a low dose oral contraceptive: a randomized trial. Contraception. 2003;67(1):nine–13.

12. Anderson FD, Hait H. A multicenter, randomized study of an extended cycle oral contraceptive [published correction appears in Contraception. 2004;69(2):175]. Contraception. 2003;68(2):89–96.

13. Seasonale (levonorgestrel/ethinyl estradiol tablets) 0.15 mg/0.03 mg [Product information]. Pomona, North.Y.: Duramed pharmaceuticals, 2003; http://www.seasonale.com/pdf/Seasonale_prescribing_info.pdf. Accessed September 24, 2007.

14. Vercellini P, Frontino Thousand, De Giorgi O, Pietropaolo Chiliad, Pasin R, Crosignani PG. Continuous utilise of oral contraceptive for endometriosis associated recurrent dysmenorrhea that does not respond to a cyclic pill regimen. Fertil Steril. 2003;80(3):560–3.

15. Vercellini P, De Giorgi O, Mosconi P, Stellato Thou, Vicentini S, Crosignani PG. Cyproterone acetate versus a continuous monophasic oral contraceptive in the treatment of recurrent pelvic pain after conservative sugery for symptomatic endometriosis. Fertil Steril. 2002;77(1):52–61.

STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided past authors who have no fiscal association with the drug manufacturer.

The series coordinator for AFP is Allen F. Shaughnessy, PharmD, Tufts University Family Medicine Residency Program at Cambridge Health Alliance, Malden, Mass.

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