Abstract
To address limitations that exist with existing definitions of menstrual bleeding
changes that occur with contraceptive methods, we assembled a panel to develop new
recommendations for standardization of bleeding data analyses associated with contraceptive
use to better inform users, clinicians, investigators, pharmaceutical companies, and
regulatory agencies. We propose three criteria for assessing bleeding outcomes: pattern,
flow, and duration. The descriptors within each criterion depend on whether the contraceptive
is designed to result in a predictable or unpredictable bleeding pattern. Predictable
pattern outcomes quantify days of scheduled, unscheduled and no bleeding, while unpredictable
pattern outcomes assess frequency. Flow is quantified based on patient comparisons
to their typical flow when not using contraception, with spotting representing no
menstrual products use. Duration of a prolonged bleeding and/or spotting episode is
more than 7 days. Studies should assess bleeding characteristics for a minimum of
12 months for 21/7, 24/4, extended cycle or continuous regimens, two years for injectables,
and the full duration of use for long-acting contraceptives. Describing pattern, flow
and duration as independent categories allows a fuller understanding of the bleeding
outcomes and better future assessments of acceptability and continuation. Standardization
of outcomes permits better comparison between studies and data synthesis; standardization
will also improve the ability of clinicians and patients to understand differences
between products.
Keywords
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Article info
Publication history
Published online: May 28, 2022
Accepted:
May 24,
2022
Received in revised form:
May 20,
2022
Received:
January 28,
2022
Identification
Copyright
© 2022 Elsevier Inc. All rights reserved.
