Endometrial Safety Study

Phase 3

Completed

• Conditions: Postmenopause
• Interventions: Drug: 0.25mg DRSP / 0.5mg E2 (BAY86-4891); Drug: 0.5mg NETA / 1.0mg E2 (Activella)

• Registration Number: NCT00522873
• Lead Sponsor: Bayer

Brief Summary

The study is designed to investigate the safety of the investigational product for the lining of the uterus (endometrium).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-29
• Study First Submitted QC: 2007-08-29
• Study First Posted: 2007-08-30
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Disposition First Submitted: 2010-09-21
• Disposition First Submitted QC: 2010-09-21
• Disposition First Posted: 2010-09-24
• Results First Submitted: 2012-03-23
• Results First Submitted QC: 2012-05-24
• Results First Posted: 2012-06-28
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-10
• Last Update Posted: 2014-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 662

Inclusion Criteria

• Postmenopausal women between 40 and 65 years of age with hormone therapy indication (symptoms and need for treatment)
• Non-hysterectomized women.

Exclusion Criteria

• Usual exclusion criteria for hormone therapy apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.25mg DRSP / 0.5mg E2 (BAY86-4891)	0.25mg DRSP / 0.5mg E2 (BAY86-4891)	One capsule \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 13 cycles (28 days per cycle).
0.5mg NETA / 1.0mg E2 (Activella)	0.5mg NETA / 1.0mg E2 (Activella)	One capsule \[0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)\] per day taken orally for 13 cycles (28 days per cycle).

Primary Outcome Measures

Name	Time	Method
Number of Participants in the DRSP/E2 Group With an Assessment of Endometrial Hyperplasia or Worse at End of Study (EoS) (1 Year of Treatment)	Up to one year	The number of women who had a biopsy classified as 'hyperplasia or worse' at any time during the study. According to the protocol this endpoint was defined as primary for the DRSP/E2 group only.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Amenorrhea During Month 1 to 3 of Treatment	Month 1 to Month 3	The women were to record daily in a diary, indicating 'no bleeding', 'spotting', 'light bleeding', 'normal bleeding' or 'heavy bleeding'. Women were considered to have amenorrhea if they had no bleeding and no spotting day within the given time interval.
Number of Participants With Amenorrhea During Month 10 to 12 of Treatment	Month 10 to Month 12	The women were to record any bleeding daily in a diary, indicating 'no bleeding', 'spotting', 'light bleeding', 'normal bleeding' or 'heavy bleeding'. Women were considered to have amenorrhea if they had no bleeding and no spotting day within the given time interval.