Internationellt pressmeddelande:
Ongoing trials will reveal that Livial® further improves quality of life without risk to postmenopausal women’s health - restoring confidence in postmenopausal women’s health

(Amsterdam, The Netherlands): Ongoing clinical studies discussed today will conclusively show whether Livial® (tibolone) further improves women’s quality of life without posing long-term health risks, particularly in relation to the breast, said Prof. Peter Kenemans, President of the Amsterdam Menopause Society (AMS).

Speaking at the 4th AMS, Prof. Kenemans (MD, PhD, VU University Medical Center, Amsterdam, The Netherlands) identified two critical priorities in the field of menopausal health. [1] He said: “First and foremost, we have to start rebuilding women’s confidence in menopausal therapies by presenting those risks that are known sensibly and appropriately; and secondly, we need to answer the questions that remain of critical importance to women through well-conducted, prospective randomized placebo-controlled studies.”

Organon’s ongoing ambitious clinical research program into Livial aims to identify the full extent of the benefits arising from this unique product. In total, these trials will collectively involve more than 10,000 women. Two major trials (LIBERATE and LISA) were discussed today more in detail.

Prof. Kenemans added: “The need for well conducted prospective randomized placebo controlled trials is more obvious than ever. This and other carefully designed ongoing trials will provide us with the conclusive data on the question of whether Livial can be the drug to provide quality over and above the relief of climacteric symptoms without adding risk to a postmenopausal woman’s life. Available evidence suggests that it has a very important role to play in the lives of postmenopausal women.”

The LIBERATE study

LIBERATE is a randomized placebo-controlled study in at least 2600 women with a history of breast cancer and serious climacteric complaints. [3] Its primary purpose is to demonstrate that Livial does not increase women’s chance of breast cancer recurrence. First results are expected in 2007.

Prof. Kenemans said: “Strong clinical data indicates that Livial does not stimulate breast tissue. On the basis of this evidence, it is clear that Livial has a very different profile in relation to the breast than menopausal therapies containing estrogen and progestogen. LIBERATE will provide the evidence needed to prove this, and extend further our knowledge about this product in relation to breast safety.”

The LISA trial

Also today, dr. Rik van Lunsen (Academic Medical Centre, University of Amsterdam, The Netherlands) explained the rationale for - LISA - a recently started study designed to identify whether Livial has a role in the management of sexual dysfunction in postmenopausal women. [4] Recent studies indicate that sexual problems are common throughout the life span of women with prevalence estimates between 25 % and 63 %.
Dr. Van Lunsen said: “The importance of sexual well being to women of all ages cannot be overstated. Sexual dysfunction is a very real problem with an enormous impact on women’s lives. Sufferers deserve medical care and attention..”

Organon - headquartered in Roseland, NJ, USA - creates and markets prescription medicines that improve the health and quality of human life. Through a combination of independent growth and business partnerships, Organon strives to become or remain one of the leading pharmaceutical companies in each of its core therapeutic fields: reproductive medicine, psychiatry and anesthesia. Organon products are sold in over 100 countries, of which more than 60 have an Organon subsidiary. Organon is the human health care business unit of Akzo Nobel.

För ytterligare information

Mats Jonsson

NOTES TO EDITORS

  1. The 4th Amsterdam Menopause Symposium is taking place in Amsterdam from 2 – 4 October.
  2. STEAR - Selective Tissue Estrogenic Activity Regulator. For more information see: Endocrine Reviews volume 25(1): 45–71 entitled Coregulator Function: A Key to Understanding Tissue Specificity of Selective Receptor Modulators by CAROLYN L. SMITH AND BERT W. O’MALLEY from the Department of Molecular and Cellular Biology, Baylor College of Medicine, Houston, Texas 2004.
  3. LIBERATE: Livial Intervention following Breast cancer: Efficacy, Recurrence And Tolerability Endpoints
  4. LISA: Livial International Study in sexual Arousal disorders

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