CompletedPhase 3

Endometrial Safety Study

United States662 participantsStarted 2007-08

Plain-language summary

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

Who can participate

Age range40 Years – 65 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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)

Timeframe: Up to one year

Trial details

NCT IDNCT00522873

SponsorBayer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-08

Results submitted2012-03-23

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