ClinicalTrials.gov record
Completed Phase 3 Interventional Results available

Low-dose Hormone Therapy for Relief of Vasomotor Symptoms

ClinicalTrials.gov ID: NCT00446199

Public ClinicalTrials.gov record NCT00446199. 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 May 19, 2026, 8:32 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 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Determine the Lowest Effective Dose of Combinations of Oral Drospirenone and 17 Beta-Estradiol for the Relief of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women Over a Treatment Period of 12 Weeks

Study identification

NCT ID
NCT00446199
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Bayer
Industry
Enrollment
735 participants

Conditions and interventions

Interventions

  • 0.25mg DRSP / 0.5mg E2 (BAY86-4891) Drug
  • 0.5mg DRSP / 0.5mg E2 (BAY86-4891) Drug
  • Estradiol (E2 0.3mg) Drug
  • Placebo Drug

Drug

Eligibility (public fields only)

Age range
40 Years and older
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
Feb 28, 2007
Primary completion
Sep 30, 2008
Completion
Oct 31, 2008
Last update posted
May 5, 2015

2007 – 2008

United States locations

U.S. sites
76
U.S. states
33
U.S. cities
67
Facility City State ZIP Site status
Not listed Mobile Alabama 36608
Not listed Chandler Arizona 85225
Not listed Phoenix Arizona 85031
Not listed Tucson Arizona 85712
Not listed Tucson Arizona 85741
Not listed Little Rock Arkansas 72205
Not listed Paramount California 90723
Not listed San Diego California 92103
Not listed San Diego California 92108
Not listed San Diego California 92121
Not listed San Diego California 92123
Not listed Valley Village California 91607
Not listed Vista California 92083
Not listed Colorado Springs Colorado 80910
Not listed Denver Colorado 80218
Not listed New Britain Connecticut 06050
Not listed Boynton Beach Florida 33437
Not listed Clearwater Florida 33761
Not listed Daytona Beach Florida 32114
Not listed Fort Myers Florida 33916
Not listed Jacksonville Florida 32216
Not listed Lake Worth Florida 33461
Not listed Leesburg Florida 34748
Not listed Miami Florida 33169
Not listed Miami Florida 33186
Not listed New Port Richey Florida 34655
Not listed Tampa Florida 33607
Not listed West Palm Beach Florida 33409
Not listed Atlanta Georgia 30328
Not listed Atlanta Georgia 30342
Not listed Decatur Georgia 30034
Not listed Boise Idaho 83702
Not listed Idaho Falls Idaho 83404
Not listed Arlington Heights Illinois 60004
Not listed Champaign Illinois 61820
Not listed La Grange Park Illinois 60526
Not listed Newburgh Indiana 47630
Not listed Lexington Kentucky 40536
Not listed Amite Louisiana 70422
Not listed Marrero Louisiana 70072
Not listed Paw Paw Michigan 49079
Not listed Chaska Minnesota 55318
Not listed Springfield Missouri 65802
Not listed Billings Montana 59101
Not listed Billings Montana 59102
Not listed Lincoln Nebraska 68510
Not listed Las Vegas Nevada 89104
Not listed Reno Nevada 89502
Not listed Lawrenceville New Jersey 08648
Not listed New Brunswick New Jersey 08901
Not listed Princeton New Jersey 08540
Not listed Albuquerque New Mexico 87102
Not listed Raleigh North Carolina 27612
Not listed Winston-Salem North Carolina 27103
Not listed Fargo North Dakota 58105
Not listed Cleveland Ohio 44122
Not listed Columbus Ohio 43213
Not listed Oklahoma City Oklahoma 73103
Not listed Tulsa Oklahoma 74105
Not listed Erie Pennsylvania 16502
Not listed Philadelphia Pennsylvania 19114
Not listed Pittsburgh Pennsylvania 15206
Not listed Wexford Pennsylvania 15090
Not listed Columbia South Carolina 29201
Not listed Sioux Falls South Dakota 57105
Not listed Chattanooga Tennessee 37403
Not listed Chattanooga Tennessee 37404
Not listed Memphis Tennessee 38120
Not listed Dallas Texas 75234
Not listed Houston Texas 77004
Not listed Houston Texas 77030
Not listed Burlington Vermont 05401
Not listed Norfolk Virginia 23507
Not listed Richmond Virginia 23294
Not listed Renton Washington 98055
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.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00446199, 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 May 5, 2015 · Synced May 19, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00446199 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →