Consider Participating in an Elagolix Study

Uterine fibroids (UF) are very common in women of reproductive age, affecting approximately 70% and 80% in white and black women, respectively, across the lifecycle. If you have been diagnosed with uterine fibroids and the doctor recommends surgery, you should know there are non-surgical methods to treat this condition. Before making an important health decision of any kind, it’s good to have all the facts, so that you can make an informed decision. Get a second opinion. Concerned that you might offend the physician by wanting a second opinion? Don’t be! Doctors want to ensure that patients get the best care based on the most accurate diagnosis. A recent study from the Mayo Clinic says that not only are diagnoses fine-tuned with a second opinion, they help cut down on unnecessary procedures which can have unintended consequences such as hampered sexual function.

A Monthly Hindrance
Are you someone who, during your monthly period, need to change pads, tampons, and also clothes so frequently you don’t want to leave the house? This puts a serious damper on work and lifestyle. The pain and heavy bleeding associated with conditions such as fibroids are the leading reasons why women undergo hysterectomy in the United States, which affects  fertility and puts women at risk for early bone loss. So, keeping your ovaries, if you can, offers the benefit of maintaining bone density that otherwise begins to decline with a hysterectomy or naturally-occurring menopause.

Menorrhagia is the medical term for menstrual periods with abnormally heavy or prolonged bleeding. Although heavy menstrual bleeding is a common concern among premenopausal women, most women don’t experience blood loss severe enough to be defined as menorrhagia. But for others, it is a show-stopper every month. With menorrhagia, every period you have causes enough blood loss and cramping that you can’t maintain your usual activities. Does this sound familiar?

Reducing Symptoms with Elagolix
If you have menstrual bleeding so heavy that you dread your period, a new and effective treatment for the disease’s most common symptoms, including pain related to menstruation and chronic pelvic pain throughout the menstrual cycle, is being tested in clinical trials and I was a part of a trial for Elagolix. Elagolix, is an oral medication that treats symptoms of uterine fibroids.  Elagolix has been shown to work well to reduce severe menstrual pain (dysmenorrhea, DYS) and non-menstrual pelvic pain (NMPP) by suppressing the hormones that feed the fibroid growth according to Abbvie’s new study. This hormone suppression is reversible when the medication is stopped.

Participants
• Women were premenopausal, 18‐51 years of age
• Women had HMB of >80mL menstrual blood loss
• Women were diagnosed with uterine fibroids with a total uterine volume of ≥200 cm 3 to ≤2,500 cm 3
• Women had no evidence of or recent history of cervical malignancy or endometrial pathology
• Women agreed to use two forms of non‐hormonal contraceptives
• Women were required to take 400 IU vitamin D and 500 to 1000 mg of calcium supplements during treatment and follow‐up periods, and if their hemoglobin concentration

The women were separated into two groups:
Elagolix alone
300mg twice daily (BID) in cohort 1
600mg once daily (QD) in cohort 2
Placebo
Elagolix with low dose add‐back (LDA) therapy of estradiol (E2)/norethindrone acetate (NETA), 0.5mg
E2/0.1mg NETA
Elagolix with standard dose add‐back (SDA) therapy of 1.0mg E2/0.5mg NETA

Women treated with elagolix with or without additional hormonal therapy (e.g,estradiol or norethindrone acetate)  had significant reductions in menstrual blood loss, compared to placebo. Trial results presented during the annual scientific meeting of The American Congress of Obstetricians and Gynecologists (ACOG) show that after six months of continuous treatment, Elagolix therapy was able to mitigate the painful symptoms and heavy bleeding and offer relief.  Some patients experienced nausea, headaches, and hot flashes, but these side effects were tolerable. We concluded that Elagolix treatment with and without add‐back therapy was superior to placebo in significantly reducing menstrual blood loss.

Weight and Race Influence Health
Risk of uterine fibroids is three times higher in black women, who tend to have an earlier age of onset, larger (number and size), more rapidly growing fibroids, and greater symptom severity than white women. Obesity is also a well-established risk factor for fibroids, with studies suggesting higher disease burden. I conducted a   phase 3 study of a new therapy that is available for these patient populations. The medication, ulipristal acetate (UPA) is an oral selective progesterone-receptor modulator (SPRM) that acts on endometrial and fibroid tissue progesterone receptors to reduce bleeding and fibroid size.
Participants
Women, 18-50 years of age
Premenopausal (follicle stimulating hormone ≤20 mIU/mL)
Excessive/prolonged uterine bleeding in ≥4 of last 6 menstrual cycles
Cyclic bleeding ≥22 days but ≤35 days
Menstrual blood loss ≥80 mL
Discrete uterine fibroid of any size and location, by transvaginal ultrasound
Uterine size ≤20 weeks by clinical exam

Of 157 women randomly selected, 148 completed treatment and 133 completed treatment-free follow-up. Patients, regardless of race or weight, who participated in the UPA trial had a significant decrease in fibroid-related bleeding, reporting an improvement to their quality of life. This is a very promising therapy that can help women who experience these health issues.

We are continuing studies on these two therapeutic options and are actively recruiting new patients to try these and related therapies.

Our Clinical Studies
If you have been diagnosed with uterine fibroids, an oral medication for the disease’s most common symptoms, including pain related to menstruation and chronic pelvic pain throughout the menstrual cycle, is available through our research study.

Eligible participants are women who are:
between 18 and 49 years of age
in good general health
experiencing heavy menstrual bleeding (menorrhagia) from uterine fibroids
be willing to discontinue current hormonal treatments for the course of screening and up to six months of treatment. Our goal, as part of a compassionate medical practice, is to maintain or regain optimal health and, shrinking, if not, eliminating, painful fibroids.

Medical insurance is not required for study participation and compensation for time and travel is provided. To learn more about the study or if you’re interested in enrolling, please contact Alisha Lutat, Vanessa Lukas, or Carol Mack, PA-C at 202-293-1000 or email us at info@jamesasimondmd.com