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Completed

NCT Number: NCT00522873

Endometrial Safety Study

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

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Key information

Conditions

Postmenopause Hot Flashes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Lanús Oeste, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

0.25mg DRSP / 0.5mg E2 (BAY86-4891)

Drug

One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).

0.5mg NETA / 1.0mg E2 (Activella)

Drug

One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle).

Primary outcomes

  1. 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

    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 outcomes

  1. Number of Participants With Amenorrhea During Month 1 to 3 of Treatment

    Time frame: Month 1 to Month 3

    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.

  2. Number of Participants With Amenorrhea During Month 10 to 12 of Treatment

    Time frame: Month 10 to Month 12

    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.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Diagnostic Cytology Laboratory
  • Laboratorium für Klinische Forschung
  • University of California, San Francisco

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Aug 30, 2007
Registry last updated
Dec 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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