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Completed Phase 3 Interventional Results available

Endometrial Safety Study

ClinicalTrials.gov ID: NCT00522873

Public ClinicalTrials.gov record NCT00522873. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 21, 2026, 4:42 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Double-blind, Randomized, Multi-center Study to Investigate the Endometrial Safety of a Continuous, Combined, Oral Estrogen/Progestin Preparation (17b-estradiol [E2] / Drospirenone [DRSP]) and to Compare the Bleeding Pattern of Subjects Treated With E2 / DRSP With the Bleeding Pattern of Subjects Treated With E2 / Norethisterone Acetate (NETA) When Used for Hormone Therapy (HT) for 1 Year in Post-menopausal Women

Study identification

NCT ID
NCT00522873
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Bayer
Industry
Enrollment
662 participants

Conditions and interventions

Conditions

Interventions

  • 0.25mg DRSP / 0.5mg E2 (BAY86-4891) Drug
  • 0.5mg NETA / 1.0mg E2 (Activella) Drug

Drug

Eligibility (public fields only)

Age range
40 Years to 65 Years
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 31, 2007
Primary completion
Jul 31, 2009
Completion
Jul 31, 2009
Last update posted
Dec 30, 2014

2007 – 2009

United States locations

U.S. sites
17
U.S. states
13
U.S. cities
16
Facility City State ZIP Site status
Not listed Chandler Arizona 85224
Not listed San Diego California 92103
Not listed San Diego California 92108
Not listed Denver Colorado 80218
Not listed Greenwood Village Colorado 80111
Not listed Boynton Beach Florida 33437
Not listed Clearwater Florida 33759
Not listed Boise Idaho 83704
Not listed Amite Louisiana 70422
Not listed Marrero Louisiana 70072
Not listed Las Vegas Nevada 89122
Not listed Cleveland Ohio 44122
Not listed Philadelphia Pennsylvania 19114
Not listed Columbia South Carolina 29201
Not listed Corpus Christi Texas 78414
Not listed Richmond Virginia 23294
Not listed Seattle Washington 98105

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 42 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00522873, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 30, 2014 · Synced Jul 21, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00522873 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →