POLYCYSTIC OVARY SYNDROME
Early therapeutic intervention is crucial
Polycystic ovary syndrome: a significant public health issue
Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age – a significant public health issue. The syndrome is characterized by hyperandrogenism and chronic anovulation/ovarian insufficiency in the absence of other specific diagnoses. Its diagnosis is rather simple and requires the application of a few standardized methods only.
Its etiology, however, remains largely unknown. Genetic, endocrine, environmental, and behavioral factors were identified, causing a complex, heterogeneous syndrome with reproductive, metabolic, and psychological characteristics. PCOS is frequently associated with insulin resistance, obesity, metabolic disorders and cardiovascular risk factors, which carry crucial health risks as age increases.
Treatment should be adapted to the specific needs of the individual patient and involves restoring fertility, treatment of the metabolic problems, therapy of androgen excess as well as endometrial protection. Therapeutic interventions mainly include metformin, combined oral contraceptives, and local treatments for hirsutism and acne.
CRS is a clinical trials‘ expert in PCOS 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 PCOS, but also in endometriosis, 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.