Extended-use OCs pose 'educational challenge': warn about breakthrough bleeding

OB/GYN News,  Oct 15, 2003  by Doug Brunk

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LA JOLLA, CALIF. -- Suppressing menstrual periods with extended-use hormonal contraceptives such as the recently approved Seasonale sounds great, but isn't that unhealthy?

"The answer is a resounding 'no,'" Dr. Andrew Kaunitz said at the annual meeting of the Association of Reproductive Health Professionals.

"This is a big educational challenge, because most women aren't familiar with the practice of hormone suppression techniques," said Dr. Kaunitz, professor of obstetrics and gynecology at the University of Florida Health Science Center Jacksonville.

"There is no medical rationale for monthly withdrawal bleeding while on hormonal contraceptives," he added.

"The menstrual blood does not build up in women using hormone contraceptives and the lining of the uterus remains healthy."

At the same time, women need to be counseled to expect early onset, unscheduled spotting and bleeding when they begin the 91-day oral contraceptive Seasonale or another other form of extended contraception. In the Phase III study of Seasonale, for example, the median number of bleeding and spotting days per month was comparable to Nordette by cycle 4.

"Over time, this will reduce and be identical to the amount of unscheduled bleeding or spotting experienced by women using conventional oral contraceptives," Dr. Kaunitz said. "This is a critical counseling point."

Women who find this unacceptable "may not be good candidates for it," he said. "The better we help women anticipate this unpredictable spotting and bleeding, the less anxiety they will experience when it occurs and the more likely they will hang in there long enough to enjoy the advantages of menstrual suppression with long-acting hormonal contraceptives."

The common breakthrough bleeding and spotting that occurs during the first 3 months of Seasonale use "is not medically consequential, but it can be very lifestyle consequential," Dr. Kaunitz added. "It can be a real hassle and make women want to quit their treatments."

He added that the packaging of Seasonale, which contains a 3-month supply of hormone pills, is a clear benefit to many patients who try to orchestrate an extended use regimen with a 21-day supply of pills.

"A lot of my patients have been hassled by their pharmacists and their managed care organization using extended oral contraceptives because they need more than one pack of pills each month," he said. "They get hassled and are denied. This packaging will be a huge plus."

Other medical options besides extended use oral Contraceptives for reducing menstruation include injectable progestin-only contraceptives, the levonorgestrel intrauterine device, oral progestins, danazol, and gonadotropin-releasing hormone.

Extended use studies of the contraceptive vaginal ring and the transdermal contraceptive patch are currently underway.

Results from two recent polls indicate that increasing numbers of women favor medically regulating their menstrual cycles.

In the first study, a phone survey of 964 Dutch women aged 15-57, over 75% of menstruating respondents preferred altered bleeding for less painful periods, shorter periods, less heavy periods, and amenorrhea (Contraception 59[6]:357-62, 1999).

A Harris Interactive poll of 491 North American women aged 18-49 commissioned by the Association of Reproductive Health Professionals in 2002 found that 44% would prefer never to menstruate, increasing to 59% for women aged 40-49. Only 29% preferred to menstruate once a month.

In addition, more than one in four women missed professional, social, athletic, or family-oriented events because of their period, menstrual cramps, or other menstrual effects.

But Dr. Kaunitz noted that not everyone supports the notion of less frequent periods. Some women "value" their monthly periods and are "emotionally attached" to them.

"We need to acknowledge and respect that," he said. "For many women, monthly menstruation is the only natural way to go. Other women see [their period] as a symbol of femininity, fertility, and youth."

Dr. Kaunitz disclosed that he receives grants and research support from Barr Laboratories Inc., which manufactures Seasonale. He added that the company supported his presentation with an unrestricted educational grant.

Who Might Benefit From Reduced Frequency Of Menstruation?

* Women with menstrual-related gynecologic or medical disorders.

* Adolescents.

* Perimenopausal women.

* Athletes.

* Women in the military.

* Developmentally delayed women.

Any women who choose to menstruate less frequently.

Source: Dr. Andrew Kaunitz

BY DOUG BRUNK San Diego Bureau

COPYRIGHT 2003 International Medical News Group
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