Research & Development

Research & Development

Uterine Fibroids

Uterine fibroids (myoma) are the most common benign, solid tumours of the female genital tract in women of reproductive age. The cardinal symptoms of uterine fibroids are excessive uterine bleeding, heavy menstrual bleeding, anaemia, abdominal pain and pressure, increased urinary frequency and infertility1. Beyond its physical morbidity, the condition is a frequent cause of significant impairment of quality of life2 and a leading reason for hysterectomy3.

Until now, uterine fibroids were commonly treated surgically with or without short-term pre-operative medical treatments with either SPRM (ulipristal acetate 5mg – Esmya®) or GnRh Agonists.

 

There was a growing demand from patients for a long-term medical treatment, as surgery may not be a suitable option for all of them, e.g. for medical or personal reasons or in peri-menopausal women who would rather wait for the symptoms of uterine fibroids decrease as result of menopause or women who are planning to become pregnant in the future.

Since 2015, Esmya® is approved for the intermittent use in moderate to severe symptoms of uterine fibroids4 providing the first long-term medical treatment option for many women.

Uterine Fibroid Fact Sheet

1 Vercellini P, Bocciolone L, Colombo A, Vendola N, Meschia M, Bolis G, “Gonadotropin releasing hormone agonist treatment before hysterectomy for menorrhagia and uterine leiofibroids”, Acta Obstet Gynecol Scand. 1993 Jul;72(5):369-73

2 Spies JB, Coyne K, Guaou GN, Boyle D, Skyrnarz-Murphy K, Gonzalves SM. “The UFS-QOL, a new disease specific symptom and health related quality of life questionnaire for leiomyomata”. Obstet. Gynecol. 2002; 99:209-300

3 Jacobson GF, Shaber RE, Armostrong MA, Hung YY. “Hysterectomy rates for benign indications”. Obstet. Gynecol. 2006; 107:1278-1283

4 Esmya® SmPC. May 2015

Endometriosis

Endometriosis is a benign gynaecological disease characterised by the presence of functional endometrial tissue fragments growing outside the uterus cavity, most frequently on the peritoneum, the ovaries, and the bowel. Like the eutopic endometrium, endometriotic tissue is oestrogen-dependent and proliferates during the menstrual cycle. At each menstruation lesions will bleed internally leading to pain, inflammation and adhesion formation. The major symptoms are chronic pelvic pain, painful menstruations and dyspareunia (painful sexual intercourse). Endometriosis is also a leading cause of infertility, with many patients seeking treatment for infertility being diagnosed with endometriosis.

Endometriosis is a highly prevalent condition in women of reproductive age affecting over 20 million women of reproductive age (EU & USA) with 5 million suffering with chronic pelvic pain. A high proportion of patients are asymptomatic, therefore the treatable patient population visiting Obstetricians and Gynaecologists is estimated at 6-7 million. The main reasons for patient visits are pain or the inability to conceive. Among women consulting for infertility, the incidence of endometriosis is 30-50%, and the incidence is as high as 70-80% among women consulting for chronic pelvic pain.

Current therapies are inadequate and range from symptom management with oral contraceptives or progestins to more aggressive treatments such as danazol or suppression of ovarian activity using GnRh agonists. The latter leads to a suppression of circulating oestrogens and its usage is restricted due to significant negative side effects.

Infertility

Infertility is a condition described as the failure to conceive after regular unprotected intercourse during at least one year for couples below 35 years, and during 6 months for couples above 35 years1. Infertility is largely unexplained in about 30% of couples, but in the remaining 70% infertility may be caused by ovulatory dysfunction, deficit in sperm count and volume, tubal damage and endometriosis. The incidence of infertility is on the rise, mostly among women in the oldest reproductive age group (35 to 44 years of age), resulting from the trend of women to delay childbearing. 10% of couples experience some form of infertility problems1. These figures translate into 10 million infertile couples in the EU, 6 million in the USA and 80 million worldwide.

1 WHO Technical Report Series 820, 1992