Preliminary efficacy of OphenaTM (ospemifene) in the treatment of vasomotor symptoms associated with the menopause: a 6-week, randomized, double-blind, placebo-controlled, parallel-group study - Hotflash-study

• Conditions: Postmenopausal symptoms (hot flashes); MedDRA version: 8.1Level: LLTClassification code 10050903Term: Postmenopausal symptoms

• Registration Number: EUCTR2006-005071-17-FI
• Lead Sponsor: Hormos Medical Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-02
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

The subject is a woman 40 to 70 years old at the time of randomization.
The subject is postmenopausal. Postmenopausal is defined as
•at least 12 months since the last spontaneous menstrual bleeding and
serum FSH levels > 40 IU/L and estradiol = 0.20 nmol/mL or
•hysterectomy with intact ovaries and serum FSH levels > 40 IU/L and
estradiol = 0.20 nmol/L or
•at least 6 weeks post- surgical bilateral oophorectomy.
The subject has at least 7 moderate, severe, or very severe hot flashes per day or 50 per week recorded for seven consecutive days. This information will be confirmed on the screening diary.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subject has taken certain hormonal medications (listed in protocol).
Subject has clinically significant abnormal gynecological findings other than vaginal atrophy at screening.
Subject has taken a selective estrogen receptor modulator (SERM) within 60 days prior to screening
Subject has clinically relevant abnormal findings in any safety laboratory tests.
Subject has current or history of thromboembolic or blood coagulation disorder.
Subject has current or history of cerebrovascular incident

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the preliminary efficacy of the OphenaTM 60 mg in the treatment of vasomotor symptoms associated with the menopause. ;Secondary Objective: Safety and tolerability.;Primary end point(s): Change in Frequency of Vasomotor Symptoms -- The total number of hot flashes per week will be determined from the HFD for the screening week (baseline measurement) and for each of the six weeks of treatment. The % change from baseline to Week 6 (End-of-Therapy) in total number of hot flashes per week will be a primary efficacy parameter.<br><br>Change in Severity of Vasomotor Symptoms -- A hot flash severity score will be calculated from each HFD for the screening week (baseline measurement) and for each of the six weeks of treatment by multiplying the number of hot flashes in each severity category (mild, moderate, severe, very severe) by the category code (1, 2, 3, 4, respectively) and summing the results.