Dinox for professionals
We are looking forward to support your project
We provide stand-alone consultancy services (dinox consultancy bv) in the field of reproductive endocrinology and female health and operate an investigational site (dinox GmbH) where ambulant female health studies can be conducted in healthy subjects or symptomatic patients.
We are specialists in Female Health Research
dinox GmbH is located in Berlin, Germany and offers an experienced team dedicated to women’s health. dinox is equipped to deal with the logistical challenge of large numbers of subjects requiring (up to daily) cycle-dependent transvaginal ultrasonography (TVUS) with frequent blood sampling, e.g. for the assessment of follicular growth.
dinox has been involved in the development of many hormonal contraceptive preparations and fertility drugs for more than 25 years. These comprise combined and progestogen-only oral preparations, vaginal rings, patches, implants and IUDs, treatment for dysmenorrhea, endometriosis and subfertility and hormone replacement therapy. Furthermore, dinox has investigated the potential interaction of several drugs with standard combined oral contraceptives. Many tested IMPs are now brand name medicinal products on the market.
dinox - strength
dinox is known for its outstanding data quality, due to a highly qualified and experienced team with dedicated in-house gynaecologists and a full established Quality Management System. The trial staff consists exclusively of health care professionals, is ICH-GCP and SOP trained and has specialised in conducting clinical trials. All trainings are reappraised and trained on a regular base. An investigator is available 24/7 in case of any subject’s health issue. Over the years, numerous studies, system- and facility audits have been conducted at dinox by well-known pharmaceutical companies. Inspections have been carried out by Dutch, German and American authorities (FDA). These audits and inspections have confirmed the high-quality standards of dinox.
Fast recruitment of healthy study subjects is guaranteed by our in-house developed database (>4000 female subjects) in combination with the recruitment of new subjects on social media in cooperation with an external marketing partner. We also have expertise in the recruitment of postmenopausal women and special populations, e.g. obese women, lactating women, women with dysmenorrhoea, acne, premenstrual syndrome, endometriosis or premenstrual dysphoric disorder. The recruitment response is intensively monitored and recruitment strategies are adapted immediately depending on the response.
All you need to know
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Areas of researchAreas of research* contraception* fertility* endometriosis* fibroids* lactation studies* hormone replacement therapy* dysmenorrhoea* anti-infectious treatments* premenstrual syndrome (PMS)* premenstrual dysphoric disorder (PMDD)* hormonal acne treatment
Clinical assessmentsClinical assessmentsBesides the standard clinical assessments (ECG, Vital Signs, BMI etc.) we offer:* transvaginal ultrasonography- follicular growth- endometrial thickness- antral follicle count- ovulation scores- 3D ultrasonography- Doppler ultrasonography* endometrial biopsy (Pipelle de Cornier®)* cervical smear* vaginal smear* cervical mucus evaluation (Insler, WHO)* IUD insertion/removal* acne lesion count* sexological assessments
LaboratoryLaboratorySampling, processing and temporary storage of blood, urine and other biological samples for determination of:* PK parameters* hormone parameters* lipid metabolism* safety profiles* hemostasis (ECAT procedure)* carbohydrate metabolism (oral glucose tolerance testing)* and many more
FacilitiesFacilities* several consulting and examination rooms including gynecological examination units* laboratory processing rooms, an archive room, a conference room and a waiting lounge for volunteers* In collaboration with other parties additional services (e.g. mammography etc) or overnight stays can be provided.
Technical equipmentTechnical equipment* advanced transvaginal ultrasound devices* equipment for sample collection, handling and storage* equipment to perform vital signs and ECG measurementsAdditional equipment can be installed upon request. Refrigerators, freezers and the IMP storage area are connected to a 24-hour temperature monitoring system which is linked to an external security company. Blood and other biological samples can be picked up daily and taken to local or central laboratories.
Clinical studiesClinical studies* Phase I: single and multiple dose pharmacokinetic trials with and without pharmacodynamic assessments, interaction studies* Phase II: proof of concept: e.g., inhibition of ovulation, ovarian stimulation, sexual functioning* Phase III: large-scale, on-site trials: e.g. Pearl-Index, cycle control, and metabolism studies (hemostasis, carbohydrates and lipids)* Phase IV: post marketing surveillance and comparative trials
Contact us
dinox GmbH
Anklamer Straße 38
10115 Berlin
Tel: +49 (0)30-440 595 22
E-Mail: kontakt(at)dinox.de