Comparison of continuous combined estrogen-progestin regimen in alleviation of estrogen deficiency symptoms of postmenopausal women. A randomized, double-blind, fixed dose, multicentre phase IIIb study of 12 month

• Conditions: Postmenopausal estrogen replacement regimen is the therapy of choice for the alleviation of climacteric symptoms. During the past few years, continuous-combined hormone replacement therapy (HRT) have become increasingly popular. Lower dose estrogen-progestogen combinations are likely to induce less bleeding disturbances and other adverse effects (AEs) and may therefore improve compliance and allow long-term treatment, necessary, e.g. for the prevention of postmenopausal bone loss.; MedDRA version: 7.0Level: LLTClassification code 10027304

• Registration Number: EUCTR2004-000053-34-CZ
• Lead Sponsor: Orion Corporation, Orion Pharma, Orionintie,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 675

Inclusion Criteria

•signed and dated IC
•Postmenopausal women: = 12 months of spontaneous amenorrhoea or = 6 weeks post-surgical bilateral oophorectomy without hysterectomy at screening
•= 30 moderate to severe hot flushes per week at baseline and/or vasomotor symptoms requiring treatment according to clinical judgement of the investigator
•Wash-out period
-is not needed or
-of 1 wk or longer for prior vaginal hormonal products (rings, creams, gels)
-of 4 wks or longer for prior transdermal estrogen alone or estrogen/progestin products
-of 4 wks or longer for prior oral estrogen and/or estrogen/progestin therapy
-of 8 wks or longer for prior intrauterine progestin therapy
-of 3 months or longer for prior progestin implants and estrogen alone injectable drug therapy
-of 6 months or longer for prior estrogen pellet therapy or progestin injectable drug therapy
•no pathological findings in mammogram obtained within 6 months of screening visit

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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•36 months of spontaneous amenorrhea at screening
•pregnancy or breastfeeding
•known or past endometrial hyperplasia or cancer
•known, past, or suspected estrogen-dependent malignant tumours (e.g. breast cancer)
•cervical smear class III-IV according to the Bethesda classification
•undiagnosed uterine bleedings
•previous idiopathic or current venous thromboembolism (deep venous thrombosis, pulmonary embolism)
•active or recent arterial thromboembolic disease (e.g. angina pectoris, myocardial infarction)
•personal or strong family history of thromboembolism or recurrent (= 3) spontaneous abortions
•heart failure (NYHA class III-IV)
•cerebrovascular accidents, stroke or transient ischemic attacks in the subject history
•serious disorders of blood coagulation system
•acute liver disease or a history of liver disease (including cholelithiasis) with clinically significant abnormalities in liver function tests at baseline
•porphyria
•uterine fibroids
•endometriosis
•known hypersensitivity to any component of the preparations
•uncontrolled or poorly controlled hypertension (diastolic BP > 95 mmHg and/or systolic BP > 160 mmHg) despite of antihypertensive treatment
•severe or uncontrolled thyroid disease, e.g. thyreotoxicosis
•impaired renal function with clinically significant elevated serum creatinine concentration
•insulin-dependent diabetes mellitus
•diagnosed psychiatric disorders (e.g. schizophrenia, depression)
•systemic lupus erythematosus (SLE)
•any other treatment for climacteric symptoms
•any treatment for hyperlipidemias
•any treatment affecting sex hormone system (e.g. phytoestrogens like soya)
•suspected alcohol or drug abuse
•suspected poor compliance
•participation in another clinical study within the previous 60 days or during the study
•clinically significant abnormalities in the laboratory assessments at baseline

Study & Design

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