Ongoing Research Studies re Endometriosis

research

Figured I’d put together a list of facilities and companies that are presently conducting research studies about Endometriosis.  I’ll update this often (some of these studies may overlap)…

All of the descriptions about these studies is directly from their websites.  If interested in participating or want more information, click on the name of the study below:

Updated 07/11/16:

AbbVie: A randomized study evaluating the safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female subjects.  The study consists of 4 periods: 1) Washout Period (if applicable); 2) a Screening Period of up to 100 days prior to first dose; 3) a 6 month Treatment Period; and 4) a Post treatment Follow-up Period of up to 12 months (if applicable). An electronic diary will be dispensed and training provided to record endometriosis-associated pain, uterine bleeding, and analgesic medication use for endometriosis-associated pain on a daily basis. Pregnancy testing will be performed monthly throughout the study. Subjects will be required to use nonhormonal dual contraception during the study, and will be counseled on appropriate and effective forms of birth control to promote pregnancy prevention.

Aljazeera Hospital: Egypt.  The aim of this randomized controlled trial is to compare operative data and early postoperative outcomes of laparoscopic excision of endometrioma using barbed sutures with those of laparoscopic excision of endometrioma using conventional sutures.

Assistance Publique – Hospitaux de Paris: France. The investigators performed a prospective multicenter comparative study to assess the maternal and fetal risks related to endometriosis during pregnancy, regarding disease phenotype, This study will evaluate with sufficient power the risk of prematurity and obstetrical complications associated with endometriosis according to disease phenotype.  This study aims to provide new informations to pregnant women with endometriosis, guide the monitoring of pregnancy, optimize management strategies based on the nature of complications and ultimately to improve the health of women and their unborn child

Australian National University: Australia (online).  We are inviting you to complete an online Endometriosis Impact Questionnaire (EIQ) developed based on 10 focus group discussions with 35 women with endometriosis.  Your valuable participation will contribute towards better understanding of the impact of endometriosis on women’s lives and to better meet the needs of women with this condition.

Bayer: Purpose of the study is to test efficacy and safety of BAY98-7196 intravaginal ring as a new treatment option for patients with endometriosis-associated pelvic pain

Brigham and Women’s Hospital: Massachusetts. We are doing this research study to find out if intravenous (in your vein, “IV”) lidocaine can lessen pain from endometriosis. The U.S. Food and Drug Administration (FDA) has approved intravenous lidocaine to treat irregular heart beats, but the FDA has not approved intravenous lidocaine to treat pain from endometriosis. Intravenous lidocaine has been used for more than 25 years to treat different acute and chronic pain conditions but has not yet been studied for endometriosis pain. This is a cross-over trial over two months where one month you will receive the active medication (lidocaine) and one month you will receive the active placebo (diphenhydramine, commonly known as benadryl). We will compare the effect on pain from endometriosis of lidocaine to active placebo.

Center for Epidemiology and Health Research: Germany.  The study assesses safety aspects of Dienogest (DNG) 2mg/day (Visanne) used as endometriosis therapy and of other hormonal treatments for endometriosis.  This study investigates the safety of DNG for endometriosis with regard to medical interventions for anemia and worsening of depressive symptoms associated with the disease. It is a prospective, controlled, non-interventional cohort study with two cohorts: users of DNG and users of other medications for the treatment of endometriosis. The study will be implemented in several European countries.

Children’s Hospital Boston: Massachusetts.   The purpose of this study is to determine whether dietary supplementation with Vitamin D or Fish Oil can help to reduce physical and emotional symptoms in adolescent girls with endometriosis.

End to Endo: The purpose of this research study is to investigate the genes responsible for predisposing women to endometriosis. By identifying these genetic variants, our team of health professionals and scientists plan to develop noninvasive diagnostics and earlier and more effective therapies for this often-debilitating condition.  We will send you a saliva sample kit.  After completion, you will send these items back to our laboratory in the postage-paid envelope we’ve provided.

Esparios:  Pennsylvania.  Qualified individuals will receive the investigational study medication, study-related medical exams, and laboratory services at no charge. They will also receive compensation for time and travel.

Florida Hospital: Florida.  The purpose of this study is to evaluate the use of fluorescence imaging + Indocyanine Green (ICG) dye (“Firefly”), compared to standard white light imaging in 2D and 3D, for accurate visual diagnosis of endometriosis during a da Vinci robotically guided endometriosis resection procedure.  The ability to accurately visualize all the lesions of endometriosis, typical and atypical in appearance, and thus facilitate complete resection of the disease, may have a significant impact on symptomatic relief and disease recurrence. The Firefly Imaging System of fluorescence imaging + ICG dye may allow for more accurate visual diagnosis of endometriosis during a robotic-assisted endometriosis resection procedure, and therefore may have a positive impact for patients with this disease.

Highland Clinical Research: Utah.  We are conducting a clinical research study to investigate the effects and effectiveness of a new oral medication indicated for the treatment of endometriosis.

Institut Universitari Dexeus: Spain.  To study the recurrences After Surgery for Deep Endometriosis Depending on the Involvement of the Surgical Margins in the Specimen

Ipsen:  China.  The purpose of this study is to describe changes in the intensity of specific endometriosis symptoms from baseline pre-surgery to after surgery and subsequent continuous Diphereline (Triptorelin Acetate) treatment for up to 24 weeks.

Northwestern University: Illinois.   The aim of this research is to assess the benefit of a medication (ulipristal) for alleviation of symptoms in women with chronic, endometriosis-related pelvic pain.  25 patients with chronic, endometriosis-related pelvic pain refractory to medical and/or surgical therapies will receive 15mg ulipristal every other day (three times a week- Monday, Thursday, Saturday) for three months.

ObsEva SA: The primary objective of this study is to assess the efficacy and safety of a range of oral doses of OBE2109 versus placebo, in reducing endometriosis associated pain.

P3 Research:  New Zealand.  Elagolix is an oral medication being developed for the management of endometriosis-associated pain and other hormone-related disorders. This study is designed to look at the safety and efficacy of Elagolix.  Elagolix is oral tablets taken twice daily. The treatment period is for six months, with a follow-up of up to 12m. Subjects complete a daily electronic diary entry (provided) and attend monthly clinic visits.

Physicians’ Research Options: Utah, Colorado.  Do you suffer from the agonizing symptoms of endometriosis? A double-blind, placebo controlled study of an investigational GnRh antagonist (non-hormone) medication. A up to 18 month study (up to six months of study participation with a one-year extension study). Participant time and travel compensation up to $2,290.00.

Repros Therapeutics Inc.: The primary objective of this study is to determine the safety and efficacy of two oral doses of Proellex administered to premenopausal women with pelvic pain associated with endometriosis confirmed within the last seven years and using prescription analgesics for symptomatic pain.

Research OutSmarts Endometriosis (ROSE): New York.  Researchers involved in ROSE are using several approaches to study endometriosis. These include efforts to better understand the genetic basis of the disease and relate this what is occurring at the cellular level in the disease, with particular emphasis on the role of stem cells and the immune system. Women both living with and living without endometriosis can participate in the ROSE study to help us find answers for those who are suffering.

Royal Surrey County Hospital: To determine the quality of life following the radical excision of recto-vaginal endometriosis.

Solstice: This study is being conducted at approximately 200 research centers worldwide.  The purpose of the study is to evaluate the safety and effectiveness of an investigational drug for moderate to severe endometriosis pain symptoms.  The investigational drug is a tablet taken by mouth that is designed to reduce the production of estrogen in the ovaries, one of the hormones associated with endometriosis pain. This study will evaluate whether the investigational drug may help manage the painful symptoms associated with endometriosis. The investigational drug is not approved by regulatory agencies as a treatment for endometriosis pain.  In this study, the investigational drug will be compared to placebo. Placebo looks the same as the investigational drug but has no active drug in it.

The Women’s Health Study: Massachusetts.  We are trying to understand the factors that affect the health of girls and women. You would be helping us by giving us one piece of this huge jigsaw puzzle.  Volunteers are asked for participation once per year. Up to $35 gift cards from Target or a major online gift card retailer is provided each time you participate.

Universitaire Ziekenhuizen Leuven: Belgium.  The purpose of the study is to evaluate the value of MRI in preoperative stratification of endometriosis patients needing surgical approach by gynaecologists only or multidisciplinary approach by gynaecologists, urologists or/and abdominal surgeons.

University Hospital, Angers: France.  The aim of this multicenter, prospective, open study is to assess sensitivity of PET with [18F] -FES for diagnosing endometriosis compared to the gold standard (histological confirmation on biopsy or excision of lesions performed during laparoscopy) in women care for suspected endometriosis and for whom laparoscopy is already scheduled.

University Hospital, Montpellier: France. A prospective cohort study would give access to clinical data of patients followed in our center, so as to identify clinical factors predicting pregnancy and to help treatment decision for women with endometriosis suffering from infertility.

University Hospital, Rouen: France.  Information is obtained from surgical and histological records and from self-questionnaires completed before surgery. Standardized gastrointestinal questionnaires (KESS, GIQLI, WEXNER, FIQL and Bristol) are routinely used to assess bowel function. Data recording, patient contact and follow-up are carried out by a clinical research technician. Postoperative follow-up is based on data from the afore-mentioned questionnaires completed at 1, 3, 5 and 7 years.

University Hospital, Rouen: France.  The purpose of this study is to determine whether, in women with deep endometriosis involving the rectum and not intending to get pregnant, continuous hormonal treatment would be followed by better digestive functional outcomes than curative rectal surgery.

University of Aarhus: Denmark.  To investigate parameters related to fertility in women with endometriosis in relation to food items.

University of Aarhus: Denmark.  A subgroup of patients with DIE has an infiltration into the rectosigmoid bowel wall (4-37%). Knowledge of the growth pattern of rectosigmoid lesions related to subjective symptoms is mandatory in order to assess the need for follow-up with transvaginal ultrasound during medical treatment.  Two different cohorts of women, based on time of diagnosis of rectosigmoid endometriosis and treatment with hormonal intrauterine device or continuous oral contraceptives will receive a questionnaire and a transvaginal ultrasound scan (measuring size and volume) at inclusion, (6) and 12 months later.

University of Aarhus: This project will investigate worsening of symptoms in endometriosis patients undergoing artificial reproductive techniques (ART). The study compares patients with peritoneal/ovarian and deep infiltrating endometriosis to relevant reference groups. Symptoms are monitored with a questionnaire with the categories quality of life, pain and bowel habits. The EHP-30® questionnaire is included in the questionnaire.

University of Aarhus: Denmark.  This study evaluates the effects of psychological treatment on pain, quality of life and work ability among women with endometriosis related chronic pelvic pain in a three-armed, randomised study. One group will receive mindfulness-based psychological treatment, the second group will receive a non-specific general psychological treatment (a psychological placebo) and the third group will be a waiting list control (treatment as usual).

University of Athens: Greece.  To evaluate the efficacy of oral contraceptives in a continuous fashion versus the usual cyclic fashion in the recurrence of endometriosis related symptoms and endometriomas following fertility-sparing surgery.

University of Cagliari: Italy.  The aim of the present study is to validate the italian version of EPH 30, a self reported questionnaire, already used internationally, in order to determine the quality of life in women with endometriosis, assess their psychological health and the effectiveness of therapies.

University of North Carolina School of Medicine: North Carolina. The purpose of this study is to determine the effects of progesterone (a naturally occurring hormone) on the endometrium during the time when embryo attachment typically occurs.  This will be compared to women with endometriosis to improve clinical diagnostics and treatments for those suffering from the condition.

University of Zurich: Switzerland.  The current study investigates the quality of life and several risk factors for the development of endometriosis as well as satisfaction with medical support in a minimum of 600 women with different stages of endometriosis and the same number of control women matched for age (± 3 years) and nationality. To evaluate specific features of endometriosis-associated pain a second group of 100 women with chronic abdominal/pelvic pain not related to endometriosis is investigated. Recruitment takes place in different university clinics, and districts hospitals in Switzerland, Germany. And Austria. Control women i.e. women without any evidence for endometriosis presenting for annual routine gynaecological controls are collected at the same places.  A composition of different internationally validated questionnaires as well as specific questions on dealing with endometriosis is used to collect information on the quality of life and potential risk factors for endometriosis. Questions on sexuality and partnership are also distributed to women’s partners.

Women’s Health Care at Frost Street:  California.  Women’s Health Care Research is seeking volunteers to take part in a clinical trial. Qualified participant may receive study-related procedures and study medication at no cost. Compensation up to $1350.00 may also be provided.

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