SAN DIEGO, Sept. 27, 2021 /PRNewswire/ -- Evofem
Biosciences, Inc., (NASDAQ: EVFM) today announced that a
manuscript on the variability of contraceptive clinical trial
design and its impact on efficacy outcomes has been published in
the peer-reviewed journal Advances in Therapy.
"The high degree of variation in the design of contraceptive
clinical trials makes comparison of efficacy outcomes challenging,
particularly when comparing non-hormonal versus hormonal
contraception," said David L.
Einsenberg, MD, of the Department of Obstetrics and
Gynecology, Washington University in
St. Louis School of Medicine, and an author of the paper. "Health
care providers should be aware of the nuances in trial design that
make direct comparisons about relative efficacy challenging in
order to effectively counsel patients choosing a contraceptive
method."
Rules related to cycle length, the absence of documented vaginal
intercourse during the cycle, and the concomitant use of another
birth control method have excluded menstrual cycles from the
efficacy analysis in some trials but not in others. Variations in
the number of menstrual cycles included affect efficacy outcomes,
i.e, fewer menstrual cycles leads to higher failure rates.
For two of the most commonly used methods of calculating
efficacy, the Pearl Index and the time-to-event analysis, inclusion
of fewer menstrual cycles results in higher calculated failure
rates. This is an important consideration when comparing findings
from studies of varying duration, e.g. seven-cycles versus
13-cycles.
Study authors also note that exclusion of cycles in which no
intercourse is documented and/or another method of contraception is
used is not reflective of how contraceptives are used in the
real-world.
"Comparing efficacy across products with varying clinical trial
designs is like comparing apples to oranges," said Brandi Howard, PhD, Evofem Biosciences' Head of
Medical Affairs. "Unfortunately, many clinicians do not understand
the nuances across clinical trials and therefore can provide
misleading contraceptive counseling to women choosing a
contraceptive method. We hope that increasing awareness with
publications such as this one, in addition to our robust Medical
Education activities, will help to improve the accuracy of
contraception counseling messages."
The manuscript, entitled Variability in
Contraceptive Clinical Trial Design and the Challenges in
Making Comparisons Across Trials, is available
online in the Posters & Publications section of Evofem's
website and
at https://link.springer.com/article/10.1007/s12325-021-01915-3
(Open Access).1 The manuscript is expected to
publish in an upcoming print edition of Advances in
Therapy.
About Evofem Biosciences
Evofem Biosciences, Inc.,
(NASDAQ: EVFM) is developing and commercializing
innovative products to address unmet needs in women's sexual
and reproductive health, including hormone-free, woman-controlled
contraception and protection from certain sexually transmitted
infections (chlamydia and gonorrhea). The Company's first
FDA-approved product, Phexxi® (lactic acid, citric acid
and potassium bitartrate), is a hormone-free, on-demand
prescription contraceptive vaginal gel. It comes in a box of 12
pre-filled applicators and is applied 0-60 minutes before each act
of sex. Learn more at phexxi.com and evofem.com.
Phexxi® is a registered trademark of Evofem
Biosciences, Inc.
1 Portman, D. et
al. Variability in Contraceptive Clinical Trial Design and
the Challenges in Making Comparisons Across
Trials. Adv
Ther (2021).
https://doi.org/10.1007/s12325-021-01915-3
Investor Relations Contact
Amy Raskopf
Evofem Biosciences, Inc.
araskopf@evofem.com
Mobile: (917) 673-5775
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SOURCE Evofem Biosciences, Inc.