Safety and Incidence of Side Effects in a Cohort of Postmenopausal Women Prescribed Ospemifene Relative to Patients Diagnosed with but not Treated for Vulvar and Vaginal Atrophy (VVA) and Patients on Selective Oestrogen Receptor Modulators (SERMs) for Oestrogen-deficiency Conditions or Breast Cancer Prevention – A Post-Authorisation Safety Study

Study identification

• EU PAS number:
  EUPAS8585
• Study ID:
  41123
• Official title and acronym:
  Safety and Incidence of Side Effects in a Cohort of Postmenopausal Women Prescribed Ospemifene Relative to Patients Diagnosed with but not Treated for Vulvar and Vaginal Atrophy (VVA) and Patients on Selective Oestrogen Receptor Modulators (SERMs) for Oestrogen-deficiency Conditions or Breast Cancer Prevention – A Post-Authorisation Safety Study
• DARWIN EU® study:
  No
• Study countries:
  Italy

  Spain

  United States
• Study description:
  Oestrogen deficiency leads to a decrease in vaginal lubrication, which is an early hallmark of vulvar and vaginal atrophy (VVA). Ospemifene is a non-steroidal selective oestrogen receptor modulator (SERM) approved in the United States for treatment of moderate to severe dyspareunia, a symptom of VVA due to menopause. The SERM class of drugs has been associated with an increased risk of venous thromboembolism (VTE) and cerebrovascular events (CVE). This post-authorisation safety study (PASS) is being undertaken to assess the safety of ospemifene in real life over a period of five years.The primary objectives are to:a) Compare the incidence of VTE, among postmenopausal women who are newly prescribed ospemifene (ospemifene cohort) to that among patients diagnosed with but not treated for VVA (untreated VVA comparison cohort).b) Compare the incidence of VTE, among postmenopausal women who are newly prescribed ospemifene (ospemifene cohort) to that among postmenopausal women newly prescribed other SERM therapies (SERM comparison cohort) being utilised for oestrogen-deficiency conditions (i.e., non-cancer and non-infertility indications) or breast cancer prevention.This is an observational, retrospective database cohort study using electronic medical records (EMR) and claims databases that will be conducted in 3-EU countries (Italy, Spain and Germany,) and in the United States. All patients with at least one ospemifene prescription or a new diagnosis of VVA with no prescription for VVA (local or systemic oestrogens) or at least one SERM prescription for an oestrogen-deficiency condition or breast cancer prevention are eligible for the study.The study duration will be up to 5 years, and annual data updates will be obtained from each data source. Annual data updates will continue until the earliest of (1) the target sample size being reached, or (2) 5 years elapsing since first EU launch.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Evidera

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 27/02/2015

Actual: 31/07/2015

Study start date

Planned: 03/06/2013

Actual: 01/05/2013

Data analysis start date

Planned: 01/04/2016

Date of interim report, if expected

Planned: 31/05/2016

Actual: 05/10/2016

Date of final study report

Planned: 31/03/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Shionogi Limited

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)