A double-blind, randomized, multi-center study to investigate the endometrial safety of a continuous, combined, oral estrogen/progestin preparation (0.5 mg 17b-estradiol [E2] / 0.25 mg drospirenone [DRSP]) and to compare the bleeding pattern of subjects treated with 0.5 mg E2 / 0.25 mg DRSP with the bleeding pattern of subjects treated with 1.0 mg E2 / 0.5 mg norethisterone acetate (NETA) when used for hormone therapy (HT) for 1 year in post-menopausal women - Angeliq low/low endometrial safety study

• Conditions: Women suffering from postmenopausal symptoms; MedDRA version: 9.1Level: LLTClassification code 10050903Term: Postmenopausal symptoms

• Registration Number: EUCTR2006-006199-39-AT
• Lead Sponsor: Bayer Schering Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

- postmenopausal women
- non-hysterectomized women
- symptoms requiring HT in the opinion of the investigator
- endometrial biopsy at screening without evidence of endometrial hyperplasia or cancer. Women who have insufficient endometrial tissue for diagnosis may be included if a transvaginal ultrasound (TVUS) shows a double-walled endometrial thickness of <5 mm
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

- no endometrial biopsy available
- usual HT exclusion criteria apply

Study & Design

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