Postmenopause Clinical Trial
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
| Verified date | December 2014 |
| Source | Bayer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The study is designed to investigate the safety of the investigational product for the lining of the uterus (endometrium).
| Status | Completed |
| Enrollment | 662 |
| Est. completion date | August 2009 |
| Est. primary completion date | August 2009 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 40 Years to 65 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Bayer | Diagnostic Cytology Laboratory, Laboratorium für Klinische Forschung, University of California, San Francisco |
United States, Argentina, Austria, Brazil, Denmark, Italy, Mexico, Russian Federation,
Genazzani AR, Schmelter T, Schaefers M, Gerlinger C, Gude K. One-year randomized study of the endometrial safety and bleeding pattern of 0.25 mg drospirenone/0.5 mg 17ß-estradiol in postmenopausal women. Climacteric. 2013 Aug;16(4):490-8. doi: 10.3109/136 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | 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. | Up to one year | Yes |
| Secondary | Number of Participants With Amenorrhea During Month 1 to 3 of Treatment | 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. | Month 1 to Month 3 | Yes |
| Secondary | Number of Participants With Amenorrhea During Month 10 to 12 of Treatment | 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. | Month 10 to Month 12 | Yes |
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