Benefits of reduced menstruation
Research at OHSU has led to new treatments available to women seeking relief from heavy menstrual bleeding and other menstrual complications.
Menstrual disorders account for over 12% of total GYN emergency room visits. The most frequent menstrual complaints are heavy menstrual bleeding (HMB) and cramping pelvic pain. While surgical options such as hysterectomy and endometrial ablation are effective treatments for heavy menstrual bleeding, both approaches have significant risks and costs. Many women with normal cycles also wish to decrease the number or intensity of menstrual bleeds or eliminate menstruation completely for lifestyle reasons. The environmental aspects of menstrual hygiene provide an additional argument for menstrual suppression. The most widely used sanitary protection products are disposable tampons and napkins. These are typically produced from virgin paper with little to no recycled content that produce environmental pollution during production and bleaching. Every year over 6.5 billion tampons and 13.5 billion sanitary pads, plus their packaging, end up in landfills or sewer systems in the United States, and over 170,000 tampon applicators are collected along U.S. coastal areas. While reusable alternatives are available, these are not practical for women with excessive bleeding. If a women with normal bleeding uses 3 menstrual hygiene products/day for 5 days each month, this translates to 195 products per year. This can easily exceed 1000 products per year in women with heavy bleeding that requires use of both a tampon and pad that is changed every hour!
Hormonal therapies are useful in alleviating menstrual symptoms in women with excessively heavy or symptomatic menstrual periods. However, until recently the only FDA approved therapies for heavy or prolonged periods had been oral medroxy progesterone acetate (MPA) and norethindone (NET). Unfortunately, neither of these treatments is highly effective, nor do they provide contraceptive protection.
Two recently completed studies done at the WHRU have led to new FDA-approved treatments for heavy menstrual bleeding. These studies were quite rigorous, requiring subjects to collect all sanitary protection used over several menstrual cycles before, and during treatment so that blood loss could be accurately measured. The first of these studies compared the levonorgestrel intrauterine system (LNG IUS, Mirena®) to MPA. Over 80% of the women treated with the LNG-IUS achieved normal or light bleeding compared to only 22.2% in the MPA group. In October 2009 the US FDA approved use of the LNG IUS as a treatment for heavy menstrual bleeding.
Although birth control pills are commonly prescribed to manage abnormal bleeding, few studies have been completed. A study performed at OHSU and other centers in North America, Europe, and Australia provided conclusive evidence for the first time that an oral contraceptive is an effective treatment for HMB. A novel extended oral contraceptive regimen containing estradiol valerate and dienogest (E2VDNG) demonstrated a clinically and statistically significant reduction in bleeding over placebo (-353.1 vs -130.4mL over a 90 day evaluation interval) in women with heavy and prolonged menstrual bleeding. Women at OHSU also participated in a separate contraceptive with this new pill. Results of these 2 studies have been presented to the FDA, and this new pill (Natazia® (Qlaira® outside of the USA)) has recently been approved for contraception, and it is expected that a duel indication for treatment of heavy bleeding will also be approved. Looking at the results from both bleeding studies, the reduction in bleeding with Natazia® is similar to Mirena® at 3 months. This new pill will also be the first to use estradiol valerate (circulates as estradiol, the same estrogen produced by the normal ovary) rather than the synthetic ethinyl estradiol (used in all other OCs). Expect to see Natazia® available sometime this summer.
So let us thank the participants in these important studies for bringing new treatment options to women. Remember that advances in women's health require the dedication of clinical trial participants. How can you become involved in the next advances in women's health? Please call our confidential recruitment number (503-494-3666) with questions or to discuss study opportunities.