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
40 Years
65 Years
Female
Postmenopause
Trial Information
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
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
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)
Outcome Description:
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.
Outcome Time Frame:
Up to one year
Safety Issue:
Yes
Principal Investigator
Bayer Study Director
Investigator Role:
Study Director
Investigator Affiliation:
Bayer
Authority:
United States: Food and Drug Administration
Study ID:
91508
NCT ID:
NCT00522873
Start Date:
August 2007
Completion Date:
August 2009
Related Keywords:
- Postmenopause
- Postmenopausal Symptoms e.g.
- Hot flushes
- Sweating episodes
- Vaginal dryness
- Adenoma
Name | Location |
|---|---|
| Phoenix, Arizona 85012 | |
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Cleveland, Ohio 44195 | |
| Philadelphia, Pennsylvania 19104 | |
| Austin, Texas 78705 | |
| Seattle, Washington 98195 | |
| McLean, Virginia 22101 | |
| Metairie, Louisiana 70006 | |
| Denver, Colorado | |
| Charleston, South Carolina | |
| Las Vegas, Nevada 89109 | |
| Coeur D'alene, Idaho 83814 |
