Medical Education Library

Extended Regimen Oral Contraceptives—Practical Management

This supplement is supported by a grant from Duramed Pharmaceuticals Inc.
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References

Disclosures (prior 12 months)

Dr Sulak has received research grants from Barr Pharmaceuticals, Inc., Berlex Laboratories, and Organon Inc; is a consultant to Barr Pharmaceuticals, Inc., Berlex Laboratories, and Wyeth; and is a speaker for Barr Pharmaceuticals, Inc., Berlex Laboratories, Merck, and Wyeth.

Dr Kaunitz has received support for clinical trials (funding to University of Florida Research Foundation) from Berlex, Duramed Pharmaceuticals, Johnson and Johnson, and Warner Chilcott. He serves as a speaker for and/or a consultant to the American College of Obstetricians and Gynecologists, Berlex, Duramed Pharmaceuticals, Johnson and Johnson, Merck, Organon, and Pfizer. He holds stock in Barr, Noven, Procter and Gamble, Roche, and sanofi-aventis.

Dr London is a speaker for and/or consultant to Berlex, Duramed, Eli Lilly and Co, Merck, Solvay Pharmaceuticals, and Wyeth.

Ms Moore is a speaker for and/or consultant to Berlex, Duramed, Organon, Ortho, and Wyeth.

Dr Nelson has served as a speaker for Barr, Berlex, FEI Women’s Health, Merck, Organon, Ortho McNeil, Pfizer, Ther-Rx, and Wyeth. She has served as an advisor for Ascend Therapeutics, Barr, Berlex, Church and Dwight, Organon, and Wyeth. She also has received research support from Berlex, Organon, Pfizer, and Wyeth.

A roundtable discussion among key thought leaders in the area of hormonal contraception was held on October 20, 2006, in New Orleans, Louisiana. These experts addressed the critical questions regarding the practical management of extended regimen oral contraceptives based on information in the medical literature.

Oral contraceptives (OCs) have been available in the United States for nearly 50 years. It is easy to forget that the introduction of reliable oral contraception—a widely available method that allows women control of their fertility—was revolutionary at that time. The decision to use a 28-day pill regimen was not a response to a physiologic need for 13 cycles per year but was dictated by the social norms and pregnancy testing technology of the day. At a time when pregnancy testing was neither easy to perform nor highly sensitive, the 7-day hormone free interval (HFI) provided a monthly reassurance to the OC user that she was not pregnant. Over the ensuing years numerous improvements in oral contraception have taken place—lowering of estrogen content due to safety concerns, confirmation of the efficacy of low-dose pills, introduction of new progestins, and phasic regimens. These changes came about due to a large number of clinical trials and other scientific assessments of OC regimens. Now with research shifted toward reducing the HFI and maximizing ovarian follicular suppression, oral contraception is undergoing a second revolution. By altering or eliminating the HFI, the goal of reducing withdrawal bleeding and minimizing hormone withdrawal can be accomplished.

Both spontaneous menstrual bleeding associated with ovulatory cycles and iatrogenically induced scheduled bleeding associated with OCs are due to endogenous or exogenous hormone withdrawal. However, the similarity ends abruptly, as menstrual bleeding fulfills a physiologic need to slough the secretory endometrium after ovulation in preparation for a new cycle and possible pregnancy. In contrast, there is no health-related reason to bleed while taking OCs. Monthly menstruation in reproductive-age women is necessary unless the patient is pregnant, using hormonal contraception, breastfeeding, or has undergone hysterectomy. A lack of cyclical menstrual bleeding in women not taking hormonal contraception is indicative of a pathologic state, whether it is the hypoestrogenic state of premature ovarian failure or the unopposed estrogen anovulatory state characteristic of women with polycystic ovarian syndrome (TABLE 1). Conversely, the recurrent ovulation and menstruation that is common among today’s post-industrial women is associated with health risks (TABLE 2).

The focus on alteration of the HFI to further improve OC therapy began with the introduction of Mircette® in 1998.1 This was followed by the introduction of Seasonale®, the first extended OC regimen2 and subsequently 2 OC products, Yaz® and Loestrin® 24 Fe, that maintained the 28-day cycle with a shortened HFI.3-5 A recently introduced OC product, Seasonique®, uses an extended 91-day regimen with low-dose ethinyl estradiol (EE) during the HFI, thus eliminating the HFI completely (TABLE 3).6

TABLE 1

Conditions Associated With Oligomenorrhea/Amenorrhea

Polycystic ovarian syndromeAnorexia nervosa
Premenarchal statusAthletic amenorrhea
Uterine adhesionsCervical stenosis
PregnancyOvarian failure
PerimenopauseOvarian tumor
Emotional stressBrain tumor
Endocrine disorders (thyroid, pituitary, adrenal)

TABLE 2

Health Risks

Recurrent Ovulation/Bleeding
Bleeding/anemiaEndometriosis with associated pain and infertility
Ovarian cancerOvarian cysts
Premenstrual syndromePremenstrual dysphoric disorder
Amenorrhea
OsteoporosisAtrophic vaginitis
Cardiac arrhythmia
Oligomenorrhea
Endometrial hyperplasiaEndometrial cancer
Infertility

TABLE 3

OC Products With Extended Regimens or Altered Hormone Free Interval

Product ContentBrandRegimenDuration of HFINo. Withdrawal Bleeding Episodes/Year
30 mcg EE/150 mcg LNG and 10 mcg EESeasonique91 days: 84 days active + 7 days low-dose EENo HFI4
20 mcg EE/1 mg NETALoestrin 24 Fe28 days: 24 days active + 4 days placebo4 days13
20 mcg EE/3 mg DRSPYaz28 days: 24 days active + 4 days placebo4 days13
20 mcg EE/150 mcg DSG and 10 mcg EEMircette28 days: 21 days active + 2 days placebo + 5 days low-dose EE2 days13
30 mcg EE/150 mcg LNGSeasonale*91 days: 84 days active + 7 days placebo7 days4
DRSP=drosperinone, DSG=desogestrel, EE=ethinyl estradiol, HFI=hormone-free interval, LNG=levonorgestrel, NETA=norethindrone acetate, OC=oral contraceptive.
*Seasonale is the only extended regimen OC for which there is a generic substitute.

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