Heavy menstrual bleeding (HMB) affects approximately one in five women and accounts for approximately one in three outpatient visits to gynecologists. Effects on women’s health and quality of life vary but can be profound. While existing drugs, devices and procedures moderate symptoms for many women with HMB, there is a clear need for better treatments.
This webinar – scheduled during National Women’s Health Week – will provide background on HMB and discuss HMB trials from the PI and patient perspectives. Andrea Lukes, MD, MHSc, FACOG, Chief Medical Officer of Health Decisions, will provide a medical overview of HMB and a PI perspective on running successful HMB trials. Dr. Lukes will then introduce a patient who will discuss her experiences in an HMB trial through recruitment and screening, randomization, the treatment period and completion of all study obligations. Dr. Lukes and her patient will participate in a Q&A and then Dr. Lukes will close with a discussion of why CRO choice is important in HMB studies.
Webinar topics will include:
Medical Background on HMB
- Anatomical (PALM) and nonanatomical (COEIN) disorders
- Current treatments, including:
- Antifibrinolytics and NSAID preparations
- Hormonal treatments, including contraceptive and noncontraceptive estrogen-progestin formulations, progesterone and progestogens
- Gonadotropin-releasing hormone agonists (GnRHs) and selective progesterone receptor modulators (SPRMs) such as ulipristal acetate (UPA)
- Surgical procedures such as endometrial ablation, myomectomy, uterine artery embolization and hysterectomy
- A levonorgestrel-releasing intrauterine system (LNG-IUS)
HMB in Women with Bleeding Disorders
- Overview of bleeding disorders
- Disorders of primary and secondary hemostasis
- Disorders of the fibrinolytic system
- Bleeding disorders in
- Premenopausal women
- Postmenopausal women
A PI’s Perspective on HMB Clinical Trials
- Differences between trials that include and exclude women with bleeding disorders
- Considerations in choice of inclusion/exclusion criteria
- Strategies for patient recruitment, prescreening and screening
- Operational challenges in HMB clinical trials, including high screen failure rates and distribution and collection of feminine hygiene products
- Menstrual blood loss endpoints in HMB trials and requirements for demonstration of efficacy
- Issues with assessments, including the spectrophotometric alkaline hematin method and qualitative visual scoring systems such as the pictorial blood loss assessment chart (PBAC)
- Regulatory perspectives on investigational drugs and medical devices/procedures
A Patient’s Experiences in an HMB Trial
- The patient tells her story
- Audience and speaker Q&A
Why CRO Choice is Important in HMB Trials
- Site selection
- Key issues: patient screening and recruitment in placebo-controlled trials, endpoints and more
An audience poll at the outset of the webinar will allow the speakers to adjust their presentations for those in attendance. The webinar will conclude with a Q&A session to allow discussion of specific issues of interest to individual attendees.
Andrea S. Lukes, MD, MHSc, FACOG, Chief Medical Officer, Health Decisions
Dr. Lukes is a board-certified OB/GYN, a Fellow of the American Congress of Obstetricians and Gynecologists and an expert on clinical development of women’s health products across a wide range of indications across the female lifecycle, including heavy menstrual bleeding and bleeding disorders. Dr. Lukes co-founded and served as the Director of Gynecology for the Women’s Hemostasis and Thrombosis Clinic at the Duke University Medical Center. She also founded the Carolina Women’s Research and Wellness Center (CWRWC), a leading private gynecologic practice and clinical research center.
Dr. Lukes has conducted or overseen more than 80 clinical trials of investigational women’s health products, including both drugs and devices, in the last ten years. Recent experience includes studies of treatment of anemia associated with uterine leiomyomas, transcervical ablation of uterine fibroids, combination drug therapy for management of menstrual bleeding associated with uterine fibroids in premenopausal women, a vapor treatment for excessive uterine bleeding, sedation during hysteroscopic tissue removal, analgesia for endometriosis-associated pain, pain management during endometrial biopsy, treatment of vulvovaginal atrophy and migraine and contraception. Dr. Lukes advises Health Decisions, biopharma and medical device companies on development and implementation of research protocols as well as facilitates communications and presentations to the FDA.
A patient and subject in a heavy menstrual bleeding trial
A patient who enrolled in and completed a heavy menstrual bleeding trial will give her perspective on considerations in going through screening, recruitment, informed consent and the experience of study participation.
Who Should Attend?
Pharmaceutical, Biotech and Diagnostic companies, with emphasis on the following titles:
- Chief Executive Officer
- Director of Research and Development
- Executive Vice President for Clinical Development
- Director of Clinical Operations
- Vice President, Clinical and Regulatory Affairs
- Directory, Regulatory and Clinical Affairs
- Vice President, Clinical Affairs
- Director of Product Development
What You Will Learn
- Medical background on HMB
- HMB in women with bleeding disorders
- A PI’s perspective on HMB clinical trials
- A patient’s experiences in a HMB trial
- Why CRO choice is important in HMB trials
Health Decisions (www.Healthdec.com) is a full-service women’s health specialty CRO dedicated to improving healthcare outcomes for all women globally. Health Decisions has 28 years of experience conducting studies of drugs, diagnostics, medical devices and combination drug/devices for reproductive-health indications. As the only full-service women’s health specialty CRO, Health Decisions provides efficient, high-quality services enabling developers of women’s health products to bring new products to market with maximum quality, speed and efficiency. Experience includes successfully executing studies and supporting regulatory submissions of a variety of women’s health products for the full spectrum of indications in women’s health, including major OB/GYN indications, infectious conditions, contraception and infertility as well as breast cancer and gynecologic oncology indications. Health Decisions has supported successful NDA, 505(b)(2), PMA and 510(k) submissions for many types of women’s health products. Health Decisions’ clients include biopharmaceutical and medical device companies, governmental agencies and non-profit organizations worldwide. Health Decisions is headquartered in Durham, NC.