Journal of Women's Health Report Confirms Satisfaction, Safety of Softcup

New Study Reveals Women Prefer Menstrual Cup to Other Protection Methods

SAN DIEGO, CA—(March 2, 2011)—A report appearing in the March 2011 issue of the Journal of Women’s Health shows that women who tried a Softcup menstrual cup preferred it to their usual method of sanitary protection.  While many women remain unaware of menstrual cups, the evaluation of 406 women shows that trial and use of the product may result in higher satisfaction than found with the current forms of protection.  The report also confirms a strong safety profile for Softcup.

The Softcup is a simple single-size disposable over-the counter (OTC) menstrual cup that compresses to tampon shape to facilitate insertion and can be worn during intercourse. The study describes preclinical evaluation, clinical testing, and post-marketing monitoring of the Softcup.

“We found that women preferred a Softcup to their usual method of sanitary protection in comfort, dryness, irritation, odor, length of wear, and interference with various activities. In addition, they were more satisfied with cup performance on light flow days,” explained Barbara B. North, M.D., Ph.D. and author of the report. “The cup received a lower rating than women’s current method in terms of convenience and disposal; leakage was rated as slightly lower. However, women preferred the cup overall.”

The study reported that 81% of enrolled women were able to insert and remove their first cup using only written instructions.  After three cycles of menstrual cup use, 37% of subjects rated the cup as better than, 29% as worse than, and 34% as equal to pads or tampons.

The study also examined the presence and frequencies of microorganisms recovered from vaginal flora before and after use of the Softcup.  Use of the cup over three successive menstrual cycles had no effect o vaginal colonization by S. aureus, the etiological agent of toxic shock syndrome (TSS).  Similarly, use of the cup does not lead to increased colonization by microorganisms associated with bacterial vaginosis (G. vaginalis and Bacteroides spp.), vulvovaginitis (Candida and other yeast), or urinary tract infections (E. coli).

 “The research revealed that menstrual cup is extremely safe; use of a Softcup does not elevate the frequency of vaginal bacteria and yeast,” said Dr. North.  “Unlike tampons, menstrual cups do not appear to significantly impact the presence of microorganisms associated with health conditions such as TSS, bacterial vaginosis or urinary tract infections.”

“Customer feedback after using the Softcup is very much in line with the findings of this study,” said Joe Pike, CEO of Evofem, Inc., the San Diego-based company that sells the Softcup.  “Our customers consistently say that once they try our product, they prefer it to their old method of menstrual protection.”

The latest study is part of a growing body of research supporting the trial of menstrual cups in the U.S. as well as globally.

“There is growing evidence that a simple, well-designed, inexpensive menstrual cup could play an important role both in developed countries and in the developing world,” continued Dr. North.  “The advantages of the menstrual cup include overall convenience, portability and easy storage, extended wear time, and greater freedom of movement.”

About the Study

The study appears in the Journal of Women’s Health, Vol. 20, No. 2, and is authored by Barbara B. North, Ph.D., M.D. and Michael J. Oldham, Ph.D.  The study examines preclinical testing complied with U.S. Food and Drug Administration (FDA) guidelines and used standard United States Pharmacopoeia methodologies for assessment of potential toxicity. Clinical testing enrolled 406 women in seven U.S. centers. A detailed written questionnaire assessed safety, acceptability, and effectiveness for menstrual collection. Study safety parameters included pelvic examinations, Pap smears, colposcopy, urinalysis, vaginal pH, wet mounts, gram stain, and vaginal microflora cultures. Post-marketing surveillance of over 100 million Softcups has been conducted by the manufacturer and by the FDA Medwatch system.

About Softcup

Softcup is a body-friendly, convenient alternative to pads and tampons. Designed by a woman, Softcup is a flexible menstrual cup worn internally, around the cervix, which collects rather than absorbs menstrual fluid. Women can wear Softcups for up to 12 hours, making it perfect for moms, runners, athletes, college students, women with irregular periods, peri-menopausal women, or any busy woman. It can be worn confidently during any type of activity, including sleeping, swimming, sports, and even during intercourse for mess-free sex. Unlike tampons, Softcup doesn't change the body's natural pH balance or contain dioxins, and is made of a non-irritating, latex-free, non-absorbent plastic material that isn't linked to toxic shock syndrome (TSS). Softcup is available at CVS (NYSE:CVS), Duane Reade, Fred Meyer, Kroger (NYSE:KR), Rite Aid (NYSE:RAD), Walgreen’s (NYSE:WAG), Walmart (NYSE:WMT) and other retailers. To order online, visit www.softcup.com.

About Evofem

Evofem, Inc., formerly Instead Inc., advances women's sexual and reproductive health through personal care, disease prevention, contraception and conception products.  Evofem provides women with greater freedom, comfort and control of their reproductive and sexual health. With dedication and passion about the struggles and issues facing all women, Evofem strives to improve their lives through innovation, charity, good will, and working with other people and organizations with similar missions.