Endometrial Safety Study

This study has been completed.
Sponsor:
Collaborators:
Laboratorium für Klinische Forschung
Diagnostic Cytology Laboratory
University of California, San Francisco
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00522873
First received: August 29, 2007
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention Phase
Postmenopause
Drug: 0.25mg DRSP / 0.5mg E2 (BAY86-4891)
Drug: 0.5mg NETA / 1.0mg E2 (Activella)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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) [ Time Frame: Up to one year ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Number of Participants With Amenorrhea During Month 1 to 3 of Treatment [ Time Frame: Month 1 to Month 3 ] [ Designated as safety issue: Yes ]
    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.

  • Number of Participants With Amenorrhea During Month 10 to 12 of Treatment [ Time Frame: Month 10 to Month 12 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 662
Study Start Date: August 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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: 0.25mg 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).
Active Comparator: 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).
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).

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00522873

  Show 59 Study Locations
Sponsors and Collaborators
Bayer
Laboratorium für Klinische Forschung
Diagnostic Cytology Laboratory
University of California, San Francisco
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications:
Responsible Party: Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00522873     History of Changes
Other Study ID Numbers: 91508, 2006-006199-39, 310523
Study First Received: August 29, 2007
Results First Received: March 23, 2012
Last Updated: May 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Postmenopausal Symptoms e.g.
Hot flushes
Sweating episodes
Vaginal dryness

Additional relevant MeSH terms:
Estradiol
Drospirenone
Norethindrone
Norethindrone acetate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Aldosterone Antagonists
Hormone Antagonists

ClinicalTrials.gov processed this record on April 22, 2014