Phase 3
N=662
Endometrial Safety Study
Postmenopause
Bottom Line
View on ClinicalTrials.gov: NCT00522873 ↗Enrolled (actual)
662
Serious AEs
3.3%
Results posted
Jun 2012
Primary outcome: 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) — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 0.25mg DRSP / 0.5mg E2 (BAY86-4891) (Drug); 0.5mg NETA / 1.0mg E2 (Activella) (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Bayer
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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) |
— | — |
| SECONDARY Number of Participants With Amenorrhea During Month 1 to 3 of Treatment |
255; 67 | — |
| SECONDARY Number of Participants With Amenorrhea During Month 10 to 12 of Treatment |
280; 89 | — |
Summary
The study is designed to investigate the safety of the investigational product for the lining of the uterus (endometrium).
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00522873). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.