services
Dinox conducts clinical trials in the field of reproductive endocrinology and female sexual health and provides consultancy services in these areas of research.
Areas of research
- contraception
- profertility
- interaction of drugs with hormonal contraceptives
- dysmenorrhoea
- premenstrual syndrome (PMS) / premenstrual dysphoric disorder (PMDD)
- acne
- endometriosis
- myoma
- sexology
- gynaecological therapy
- lactation
- hormone replacement therapy
Clinical studies performed by dinox
- 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: postmarketing surveillance and comparative trials
Clinical site
- conduct of phase I-IV studies
- submission to ethics committee and/or competent authority
- subject recruitment
- ICF writing
- all pharmacodynamic methods in female health research
- laboratory logistics
- sample storage and shipment
- interpretation of study results
Pharmacodynamic and clinical assessments
- 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
- bio-impedance measurement (body fat)
- sexological assessments
Laboratory
Sampling, processing and 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
Recruitment
We use an in-house developed database in combination with an online platform (social media). The database allows for an historical overview of trials per subject and follow-up of individuals. We have in excess of 4000 healthy female volunteers included in our database. In addition, we have access to postmenopausal women and to special populations, e.g. obese women, lactating women, women with dysmenorrhoea, acne, premenstrual syndrome or premenstrual dysphoric disorder. The recruitment response is intensively monitored and recruitment strategies are adapted immediately depending on the response.
In collaboration with other parties
The following services can be provided in close collaboration with other parties:
- overnight stays
- mammography
- bone densitometry
- laboratory determinations
- pharmacy
- monitoring
- data management
- biometrics
