Services

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 (haemostasis, carbohydrates and lipids)
  • Phase IV: postmarketing surveillance and comparative trials

 

Clinical sites

  • 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
  • haemostasis (ECAT procedure)
  • carbohydrate metabolism (oral glucose tolerance testing)
  • etc.

 

Recruitment

Both clinical sites use an in-house developed database which allows for an historical overview of trials per subject and a follow-up of individuals. Per site approximately 3000 actively participating healthy young volunteers are included in the database. In addition, the sites 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. Subject recruitment is performed by the medical staff. The recruitment response is intensively monitored and recruitment strategies are adapted immediately, if required, 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

 

dinox consultancy

dinox consultancy advises on study design, data interpretation and other issues in the area of research, on recruitment and on all issues concerning the female population in clinical studies. Additionally, medical writing services and training sessions are provided.