Status: Ongoing First registered on: 11/02/2015
Last updated on: 12/10/2018
1. Study identification
EU PAS Register NumberEUPAS8585
Official titleSafety 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 title acronym
Study typeObservational study
Brief description of the studyOestrogen 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.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 1 (imposed as condition of marketing authorisation)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsEvidera
Department/Research group
Organisation/affiliationEvidera
Website/Homepagewww.evidera.com
Details of (Primary) lead investigator
Title Dr
Last name Nordstrom
First name Beth
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
International study

Italy
Spain
United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed27/02/201531/07/2015
Start date of data collection03/06/201301/05/2013
Start date of data analysis01/04/2016
Date of interim report, if expected31/05/201605/10/2016
Date of final study report31/03/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesShionogi Limited100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Gibbs
First name Trevor
Address line 1Shionogi Limited, 33 Kingsway
Address line 2 
Address line 3 
CityLondon 
PostcodeWC2B 6UF 
CountryUnited Kingdom
Phone number (incl. country code)44-2030-534137 
Alternative phone number 
Fax number (incl. country code) 
Email address trevor.gibbs@shionogi.eu
Public Enquiries
Title Dr 
Last name Gibbs 
First name Trevor 
Address line 1Shionogi Limited, 33 Kingsway 
Address line 2 
Address line 3 
CityLondon 
PostcodeWC2B 6UF 
CountryUnited Kingdom 
Phone number (incl. country code)44-2030-534137 
Alternative phone number 
Fax number (incl. country code) 
Email address trevor.gibbs@shionogi.eu 
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