MBN, Monte Bubbles Network

-- Sometimes it's the little things in life that really get to you. According to a recent survey, more than three- fourths (78%) of women ages 18 to 49 rank having their period among the top five most annoying items on a list that includes gaining weight, arguing with a spouse or significant other, having a bad hair day, having a bad boss and commuting to and from work. The survey also found that more than two-thirds (68%) of women ages 18 to 49 who still may get a period(1) wish they had a shorter period.

Help for these women is at hand in the form of a new birth control pill that is now available: Loestrin(R) 24 Fe (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets), the first oral contraceptive approved in the United States that provides 24 days of active hormonal pills and four days of placebo pills.

"The clinical data show that monthly periods are shorter and lighter with Loestrin 24 than with a traditional 21-day oral contraceptive," said Dr. Michelle Warren, Professor of Medicine and Obstetrics and Gynecology, Columbia University Medical Center. "This is going to be a significant benefit to many of my patients who look for lifestyle advantages from their birth control pills, in addition to the contraceptive benefits."

Harris Interactive(R), commissioned by Warner Chilcott, conducted an online survey of 1,342 U.S. women ages 18 to 49 in March 2006. Some of the questions were asked only of 1,249 women who still may get a period and some were asked only of 952 women who currently use or have ever used hormonal contraceptives (defined as birth control pills, the birth control patch or the vaginal ring).

The survey asked all women to rank the top five most annoying items, including gaining weight (87%); arguing with my spouse or significant other (80%); having my period (78%); having a bad boss (78%); having a bad hair day (57%); commuting to and from work (48%); doing my taxes (46%), and other (24%).

Periods and Oral Contraceptives

Nearly half (48%) of women ages 18 to 49 who still may get a period said their period was somewhat disruptive to activities of their daily life, and an additional 17% said it was disruptive or very disruptive. Asked to rate the level of discomfort their period causes them, 42% said it causes them a fair amount or a lot of discomfort.

In the survey, 85% of women who are current or former users of hormonal contraception felt that having a shorter period would make a positive difference. In addition, 84% of the 933 women ages 18 to 49 who currently use or have ever used a birth control pill agreed that a monthly period is a natural way for their body to work. More than half (56%) of these current and former oral contraceptive (OC) users wished there were an OC that gave them lighter periods; 55% wished there were an OC that gave them shorter periods.

Methodology

Harris Interactive(R) fielded the online survey on behalf of Warner Chilcott between March 9 and 13 and March 15 and 17, 2006 among a nationwide sample of 1,342 women ages 18 to 49, including women who have not had a hysterectomy (1,249), women who are currently using a hormonal contraceptive (birth control pill, patch or vaginal ring) or have in the past (952), and women who are currently using a birth control pill or have in the past (933). The data were weighted to be representative of the total U.S. adult population on the basis of region, age within gender, education, household income, race/ethnicity and propensity to be online. Though this online sample is not a probability sample, in theory, with a probability sample of this size, one can say with 95 percent certainty that the results for the overall sample have a sampling error of plus or minus 4 percentage points. Sampling error for sub- samples is higher and varies.

Loestrin 24 Fe: Shorter Periods at Last

Loestrin 24 Fe, made by Warner Chilcott, is the first oral contraceptive approved by the U.S. Food and Drug Administration that provides 24 days of active hormonal pills, and only four days of inactive pills. A pivotal clinical trial showed that this regimen produced a shorter menstrual period than a traditional oral contraceptive. Traditional oral contraceptives are taken for 21 days followed by seven days of placebo pills. The clinical data showed that by the end of the sixth cycle studied, women who took Loestrin 24 Fe had periods that were 2.7 days on average, compared to 3.9 days with the traditional 21-day regimen. Women aged 36 and older who took Loestrin 24 Fe had even shorter periods, on average 2.5 days at the end of six cycles, compared to 4.2 days for the women taking the 21-day regimen. In addition, the women taking Loestrin 24 Fe reported that their periods were significantly lighter compared to those on the 21-day therapy.

"More than ninety percent of my patients would want a shorter, lighter period," said Dr. Tyrone Malloy, Medical Director, Metropolitan Atlanta Obstetrics and Gynecology. "My experience with patients on Loestrin 24 has been that it provides the reassurance of a monthly period, and the periods averaged less than three days in length."

Clinical Data

A six cycle, open-label, randomized study of healthy women ages 18 to 45 at risk for pregnancy compared the efficacy of Loestrin 24 Fe with a 21-day birth control pill (Loestrin Fe 1/20 or "Loestrin 1/20") in preventing pregnancy, and evaluated the safety and tolerability of Loestrin 24 Fe. Of 886 study participants, 705 were randomized to take Loestrin 24 Fe and 181 were randomized to take Loestrin 1/20.

The study found that both Loestrin 24 Fe and Loestrin 1/20 were effective in preventing pregnancy. The Pearl Index score, the measure of effectiveness, was 1.82 for Loestrin 24 Fe and 2.98 for Loestrin 1/20. The Pearl Index is defined as the number of pregnancies per 100 women treated for one year.

The most commonly reported adverse events in both groups were headache, vaginal candidiasis, upper respiratory tract infection, nausea and dysmenorrhea. Adverse events were generally mild to moderate in severity and were similar in both groups.

Oral contraceptives are not for everybody. Most side effects of the Pill are not serious and those that are, occur infrequently. Serious risks, which can be life threatening, include blood clots, stroke, and heart attacks, and are increased if women smoke cigarettes. Cigarette smoking increases the risk of serious cardiovascular side effects, especially in women over 35. Women who use oral contraceptives should not smoke. Some women should not use the Pill, including women who have or have had blood clots, certain cancers, a history of heart attack or stroke, as well as those who are or may be pregnant. The Pill does not protect against HIV or sexually transmitted diseases. Additional information about Loestrin 24 Fe is available at www.shortperiod.com.

Warner Chilcott

Warner Chilcott is a specialty pharmaceutical company focused on developing, manufacturing, marketing and selling branded prescription pharmaceutical products in women's healthcare and dermatology in the U.S.

About Harris Interactive(R)

Harris Interactive, the fastest-growing market research firm in the world, is widely known for The Harris Poll(R) and for pioneering online market research methods. Harris Interactive is headquartered in Rochester, New York, and European operations are based in London.

(1) Women who still may get a period are defined as women ages 18 to 49

who have not had a hysterectomy (surgical removal of their uterus).

Source: Warner Chilcott