Obstetrics and Gynecology Clinical Trials Ongoing at University Hospitals

Trials enroll participants for menstrual, pre-eclampsia and other therapies

Innovations in Obstetrics & Gynecology | Winter 2020

James Liu, MD

Women struggling with gynecological challenges may be eligible to participate in one of several clinical trials at University Hospitals, says James Liu, MD, reproductive endocrinologist and Chair, Obstetrics & Gynecology, University Hospitals Cleveland Medical Center, and professor and Chair, Department of Reproductive Biology, Case Western Reserve University School of Medicine.

ENDOMETRIOSIS

Endometriosis, the growth of endometrial lining cells outside the uterus, affects roughly 1 in 10 U.S. women and can cause pain, bleeding, gastrointestinal problems and adhesions. The prevalence is even higher in women who delay childbearing, and approximately 40 percent of women with infertility have endometriosis, according to the American College of Obstetricians and Gynecologists (ACOG).
UH is currently enrolling patients in two trials for new endometriosis therapies:

Linzagolix. This clinical trial will assess the efficacy and safety of linzagolix in women with moderate to severe endometriosis pain. The trial is sponsored by ObsEva SA.

“Linzagolix is a pill that treats endometriosis by targeting the pituitary gland, which lowers the estrogen produced in the ovaries and essentially starves the endometriosis,” Dr. Liu explains.

Linzagolix is a once-a-day oral medication that researchers hope will maintain estradiol levels in a range that protects bone mineral density, a shortcoming of GnRH agonist therapies.

MT-2990. “MT-2990 is a monoclonal antibody,” says Dr. Liu. “It targets one specific protein associated with endometriosis. Although monoclonal antibodies are used in other applications, such as cancer and osteoporosis, this trial will assess the safety and efficacy of a monoclonal antibody in treating endometriosis.”

The investigational study is sponsored by Mitsubishi Tanabe Pharma Development America Inc. and targets women 18- to 49-years-old with diagnosed endometriosis.

UTERINE FIBROIDS/HEAVY MENSTRUAL BLEEDING

Uterine fibroids are benign, smooth muscle growths on the uterus. They occur with greater frequency in African American women and often are associated with increased uterine bleeding. Nearly 1 in 3 women seek treatment for heavy menstrual bleeding. Left untreated, it can lead to iron-deficient anemia.

UH clinical trials in this area are:

Elagolix. UH is participating in a Phase III study to evaluate the safety and efficacy of elagolix (Orilissa), an active, nonpeptidic GnRH antagonist, in combination with norethindrone acetate or estradiol/norethindrone acetate. The trial is sponsored by AbbVie.

“Elagolix is a daily tablet that shuts down stimulation to the ovaries so they produce very little estrogen,” says Dr. Liu. “It causes uterine fibroids to shrink in size and reduces uterine bleeding."

New IUD. The 52-mg levonorgestrel-releasing intrauterine system (52-LNG-IUS) may treat idiopathic heavy menstrual bleeding, a condition especially common in women who’ve had several children, says Dr. Liu. UH is enrolling patients in a Phase III trial to assess the safety and efficacy of 52-LNG-IUS.

“The IUD controls the bleeding by inducing a thin uterine lining due to the progesterone released from the IUD,” says Dr. Liu. “This is a new design, a generic-type version of the popular Mirena IUD, but much less expensive. We’re testing it for the manufacturer, Medicines360.”

PRE-ECLAMPSIA

According to ACOG, pre-eclampsia and hypertensive disorders in pregnancy are on the rise and complicate up to 10 percent of pregnancies worldwide, contributing to significant maternal and perinatal morbidity and mortality.

UH is participating in a clinical trial sponsored by AMAG Pharmaceuticals Inc. to determine if infused DigiFab (digoxin immune FAB) treats pre-eclampsia and helps reduce the number of infants who have severe intraventricular hemorrhage, necrotizing enterocolitis or death by 36 weeks gestation.

“DigiFab is an antibody directed against a protein that appears to be triggering pre-eclampsia,” Dr. Liu says.

CONTRACEPTION

The options for women who want permanent birth control traditionally have been limited to surgically tying off the Fallopian tubes.

“UH is testing FemBloc, a permanent contraception system for in-office application,” Dr. Liu explains. “We insert a little balloon in the uterus, orient it much like an IUD, and inject a superglue-like substance, a biopolymer. It induces scar tissue at the entrance to the Fallopian tubes where they join the uterus. Eventually, the biopolymer falls out.

“After a few months, we do an ultrasound to confirm the Fallopian tubes are blocked,” he says. “UH has performed several of these procedures already and is one of only five sites in the country participating in the second phase of this trial.”

The FemBloc Contraception Pivotal Trial is sponsored by Femasys Inc.

HOT FLASHES

Approximately 70 percent of menopausal women suffer from hot flashes. Fezolinetant, a nonhormonal therapy, may help.

“Fezolinetant is an oral medication and a neurokinin receptor antagonist,” Dr. Liu explains. “It works at the level of the brain, targeting chemicals that stimulate hot flashes.”

He expects this trial, sponsored by Astellas Pharma Global Development Inc., to begin recruiting participants later this spring.