MedTrace Logo

Endometrial Safety Study

NCT00522873 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 662

Last updated 2014-12-31

Study results available
· View outcomes & findings →

Summary

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

Conditions

  • Postmenopause

Interventions

DRUG

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).

DRUG

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).

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • United States
  • Argentina
  • Austria
  • Brazil
  • Denmark
  • Italy
  • Mexico
  • Russia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00522873 on ClinicalTrials.gov