Phase 3
Completed N=662
Endometrial Safety Study
Postmenopause
Source: ClinicalTrials.gov NCT00522873 ↗
Enrolled (actual)
662
Serious AEs
3.3%
Results posted
Jun 2012
Primary outcomePrimary: 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
Summary
The study is designed to investigate the safety of the investigational product for the lining of the uterus (endometrium).
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 | — |
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. Informational only — not medical advice.