Multiple Dose Study of Transdermal Administration of Teriparatide v01

• Research type

  Research Study

• Full title

  A Multiple-Dose Study to Evaluate Skin Irritation and Sensitisation of Teriparatide Administered Transdermally in Healthy Postmenopausal Women

• IRAS ID

  63062

• Contact name

  Prishil Koovejee

• Sponsor organisation

  ELI LILLY AND COMPANY

• Eudract number

  2010-020001-33

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Teriparatide is a drug used to treat osteoporosis (a disease of the bones that leads to bone fragility and an increased risk of fracture). Osteoporosis is the most common human bone disease. Teriparatide is currently given as an injection under the skin once a day. However, many patients with severe osteoporosis are unable or unwilling to inject themselves and there is therefore a need to develop an alternative method of giving the drug. Some drugs can be given using a patch applied to the skin and this method of giving a drug is being investigated for Teriparatide. Patches and the drugs delivered by the patches can sometimes lead to skin irritation or sensitive skin. As the condition of the skin can affect the delivery of the drug, how well it works and potentially its safety, it is important to investigate the effects of a drug containing patch on the skin. This will be investigated in the two parts of this study: Part A will investigate whether applying a patch containing Teriparatide causes skin irritation when it is used for 6 hours a day for 22 days in a row. Part B will investigate whether applying a patch containing Teriparatide causes skin sensitisation when used for 6 hours a day on 4 days a week for 3 weeks. Both parts of the study will also investigate how well the Teriparatide patch adheres to the skin and the safety and tolerability of the Teriparatide patch. Study participants will be healthy females aged 45 years or over who have been through the menopause. The study will be conducted at Contract Research Organisation (CRO) sites. Participation will last approximately 49 to 86 days.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  10/IEC04/18

• Date of REC Opinion

  26 Oct 2010

• REC opinion

  Further Information Favourable Opinion