Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,886 participants across five groups. Each group received a different treatment: two groups received a combination of bazedoxifene (20 mg) with conjugated estrogens at either a lower (0.45 mg) or higher (0.625 mg) dose; one group received bazedoxifene (20 mg) alone; one group received a different hormone combination (conjugated estrogens 0.45 mg with medroxyprogesterone acetate 1.5 mg); and one group received a placebo (an inactive dummy treatment). The trial was measuring two main things: whether the uterine lining showed abnormal thickening (called endometrial hyperplasia) after 12 months, and whether bone density in the spine changed over the same period in a smaller sub-group of participants. The reported data shows that, for the uterine lining outcome, the percentage of participants found to have abnormal thickening ranged from 0.00% (bazedoxifene alone and the hormone combination groups) to 0.85% (placebo), with the two bazedoxifene-plus-estrogen combination groups sitting at 0.30% and 0.54% respectively, under the first of two measurement definitions used. For the spine bone density sub-study, the reported average percentage change from the starting point at 12 months ranged from a decrease of 1.28% in the placebo group to increases of 0.07%, 0.24%, 0.60%, and 1.30% across the four active treatment groups. Secondary measurements included changes in hip bone density, breast density, and the proportion of participants who had no bleeding or spotting over the year — that figure (called cumulative amenorrhea) ranged from around 54% in the hormone combination group up to roughly 88% in one of the bazedoxifene-plus-estrogen groups. The reported data also shows that breast density (measured in a separate sub-group) changed by between −0.45% and −0.25% in the bazedoxifene-containing groups and the placebo group, while the conjugated estrogens/medroxyprogesterone group showed an average increase of 1.60%. These are numbers reported from the trial measurements and do not on their own tell us what those changes mean for any individual person's health. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 24438370) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Osteoporosis Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- Women aged 40 to 64 who are generally healthy, have gone through menopause, and are looking for treatment to help with menopause symptoms
- Women who have not had a period for at least 12 months on their own, OR have not had a period for at least 6 months and have hormone test results showing FSH levels above 40 mIU/mL (confirm with trial site)
- Women who still have their uterus (have not had a hysterectomy)
Who may not be able to join:
- Women who have used certain hormone-based medications — including estrogen, progestin, androgen, or SERMs (a type of hormone-related drug) — in the 8 weeks before the screening appointment
- Women who have a history of, or are currently dealing with, serious medical conditions such as heart disease, stroke, heart attack, long-term kidney or liver disease, breast cancer, or similar significant illnesses
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Pfizer CT.gov Call Center, Pfizer
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
3 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants With Endometrial Hyperplasia at Month 12: Main Study; Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12: Osteoporosis Sub-Study
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.