ENDOMETRIOSIS

Ready for research into new effective therapies

Diagnosis and treatment of endometriosis – a medical challenge

Endometriosis is a chronic inflammatory hormone-dependent disease defined as endometrial glands or stroma in ectopic locations outside the uterus. It is a common condition affecting 10 percent of premenopausal women globally and 70 percent of women with chronic pelvic pain.

Its pathogenesis remains unclear, but hypotheses regarding the origin of ectopic endometrial implants (so-called lesions) comprise retrograde menstruation, implanted stem cells, Müllerian remnants and transdifferentiating blood cells. Confounding etiologic factors identified were genetic predisposition, progesterone resistance, inflammation, angiogenesis, vascularization processes, oxidative stress, resistance to apoptosis, and immunological processes.

Symptoms include chronic and cycle-dependent severe pain, dysmenorrhea, dyspareunia, dysuria, infertility, and fatigue among others. Despite this range of symptoms, a diagnosis is often delayed, resulting in unnecessary suffering and reduced quality of life.

Women suffering endometriosis hope for better therapies

Usually, endometriosis is initially suspected clinically and possibly confirmed by imaging methods. Still, the diagnostic gold standard is a visual inspection during laparoscopy and the histopathological analysis of lesions collected. This surgical method can serve as therapy as well but may not be overall effective and comes with risk factors.

In general, treatment aims at mitigating symptoms and achieving pregnancies if desired by affected individuals.

Systemic hormone therapy and analgesics are offered to treat endometriosis-related pain, both with limited efficacy and potential adverse side effects. Recognition of the full scope of the disease will allow for a more comprehensive treatment to optimize and personalize endometriosis care. However, research for new effective therapies is desirable.

CRS is a clinical trials‘ expert in endometriosis and other women’s health concerns

CRS offers outstanding expertise and extensive experience in the conduct of women’s health studies with healthy volunteers and patients not only in the indication of endometriosis, but also in polycystic ovary syndrome (PCOS), contraception, heavy menstrual bleeding, hormone replacement / postmenopausal status, sexual dysfunction, uterine fibroids, and in vitro fertilization among others.

Besides a strong network of referral gynecologists, CRS has contracted five experienced and Board-certified gynecologists to perform examinations in house.

The methods used by CRS comprise

• Gynecological examination
• Transvaginal ultrasound
• Vaginal cytology
• Endometrial biopsy
• Insler score
• Hoogland score
• Monitoring of follicular growth/ovulation
• Rating scales / questionnaires (e.g. QoL, sleep, pain)

CRS collaborates with numerous central laboratories and also has a long-lasting cooperation with a certified local laboratory that offers standardized safety examinations and a broad spectrum of hormone assays. CRS also has specialized partners for analyzing PAP smears and endometrial histology at its disposal.

CRS provides excellent support at all levels of clinical research

CRS’ basis of its highly effective recruitment for clinical trials in endometriosis and women’s health is the maintenance of a powerful volunteers and patients database together with a solid network of collaborating medical specialists and office-based family doctors and gynecologists.

CRS’ excellent equipped and strictly quality controlled early phase units lay the groundwork for the conduct of clinical trials in accordance with Good Clinical Practice (GCP) and with all requirements of competent authorities and ethics commitees, e.g., the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Together with selected external clinical centers of excellence CRS is able to provide a wide range of studies bridging from preclinical evidence to proof-of-concept in healthy humans or patients with endometriosis or other women’s diseases.

CRS is well experienced in being responsible for the submission of the request to the competent authorities for authorization of a clinical trial. Upfront of the submission process, CRS is also committed to engage with the sponsor at any scientific advice meetings with the competent authorities.

Our experienced scientists, medical experts, investigators, statisticians and medical writers will provide essential support in creating meaningful study outlines or writing study protocols and investigational brochures, finalizing study reports, and drafting manuscripts for publication in scientific journals after completion of the clinical trial.

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