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Inhibition of Menses (Bleeding Profile)

In a clinical trial (313-NA) that evaluated the safety and efficacy of LYBREL® in 2,134 women aged 18 to 49 years, the bleeding profile was also assessed.10 This study enrolled women who were new users of combination oral contraceptives (COCs) or had previously used COCs and did not exclude those with a history of breakthrough bleeding and/or spotting.9 Women recorded their bleeding experiences during 13 pill packs (1 year) of therapy with LYBREL in a daily diary as breakthrough bleeding, spotting, or amenorrhea.9 The definitions of breakthrough bleeding (requiring sanitary protection), spotting (not requiring sanitary protection), and amenorrhea used in this study were as proposed by the World Health Organization11 and may vary from those used in other OC studies.

In those subjects who provided complete bleeding data for all 13 pill packs (n=779), the percentage of patients who were amenorrheic in a given pill pack and remained amenorrheic through pill pack 13 (cumulative amenorrhea rate) was determined (Figure 1). 1,9 Approximately 21% of women were amenorrheic from pill pack 7 through pill pack 13.9

FIGURE 1. Percentage of subjects with cumulative amenorrhea for each pill pack through pill pack 13.1,9

A separate analysis evaluated bleeding during each pill pack. Figure 2 shows the percentage of women by pill pack who experienced unscheduled bleeding, spotting only, or amenorrhea. At pill pack 3 (n=1,671), 27% of women had amenorrhea, and an additional 26% of women had spotting only9; 48% of women had unscheduled bleeding.9 At pill pack 13 (n=860), 59% of women had amenorrhea, and an additional 20% of women had spotting only9; 21% of women had unscheduled bleeding.9

FIGURE 2. Incidence of amenorrhea, spotting only, and bleeding in each pill pack of LYBREL over 1 year.9

Of the 2,134 women who received LYBREL in clinical trial 313-NA:

  • Approximately 18% of women discontinued prematurely due to vaginal bleeding.1
    • 9.8% of subjects cited vaginal bleeding among their reasons for discontinuation.9
    • 8.3% of subjects discontinued the study because of bleeding-related adverse events (AEs).9

Overall, 56.8% of women discontinued LYBREL over 1 year of treatment1—including 4.8% who were discontinued by the study sponsor.9 The most common reasons for discontinuation included adverse events (17.0%) and subject request (15.7%).10

Unplanned breakthrough bleeding is common in the first 3 months with many COCs.12 A recent review of the literature13 identified 4 factors that may contribute to breakthrough bleeding in women using COCs. These factors include the physiologic effects of COCs on the endometrium; COC-related factors (including dose, formulation, and regimen); patient behavior (including adherence, use of concomitant medications, and smoking); and the presence of underlying conditions (eg, endometrial polyps)14 or infection (eg, Chlamydia trachomatis).15

The percentage of women taking LYBREL who experienced ≥4 or ≥7 days of breakthrough bleeding or spotting per pill pack decreased over time during clinical trial 313-NA.1 During pill pack 2, 67% of subjects experienced 4 or more days of bleeding and/or spotting, and 54% of these subjects experienced 7 or more days of bleeding and/or spotting.1 During pill pack 13, these percentages were 31% and 20%, respectively.1

FIGURE 3. Percentage of subjects reporting greater than or equal to 4 or 7 days of bleeding and/or spotting per pill pack.1

When prescribing LYBREL, the convenience of having no scheduled menstrual bleeding should be weighed against the inconvenience of unscheduled breakthrough bleeding and spotting.1 Unscheduled bleeding or spotting is likely to occur while taking LYBREL. Unscheduled bleeding or spotting occurs most often during the first seven pill packs of LYBREL use. It tends to decrease with subsequent pill packs of use, but may occur after taking LYBREL for some time. In a study of LYBREL, 60% of women had bleeding and/or spotting during the sixth pill pack of use. Bleeding and/or spotting decreased to 48% during pill pack 9, and to 41% during pill pack 13.1

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Important Safety Information

  • Oral contraceptives (OCs) do not protect against HIV infection or other sexually transmitted diseases.
  • When prescribing LYBREL, the convenience of having no scheduled menstrual bleeding should be weighed against the inconvenience of unscheduled breakthrough bleeding and spotting.
  • OCs are contraindicated in women who have blood clots; breast, uterine, or liver cancers; a history of heart attack, stroke, or breast cancer; as well as those who are or may be pregnant.
The risks of serious cardiovascular side effects are substantially increased in women who smoke and use OCs, especially in women over age 35. Women who use oral contraceptives should be strongly advised not to smoke.
  • Serious risks associated with OCs include blood clots, heart attack, and stroke.
  • LYBREL provides women with more hormonal exposure on a yearly basis (13 additional weeks of hormone intake per year) than conventional cyclic oral contraceptives containing the same strength of synthetic estrogens and similar strength of progestins.
  • Scheduled withdrawal bleeding does not occur with the use of LYBREL, therefore, the absence of withdrawal bleeding cannot be used as a sign of an unexpected pregnancy and as such, unexpected pregnancy may be difficult to recognize. Although pregnancy is unlikely if LYBREL is taken as directed, if for any reason, pregnancy is suspected in a woman using LYBREL, a pregnancy test should be performed.
  • The most commonly reported treatment emergent adverse events reported with LYBREL in a clinical trial were headache, dysmenorrhea, upper respiratory infection, vaginal bleeding (defined as metrorrhagia and vaginal hemorrhage), and nausea.

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