Phase 3 N=1,083 Randomized Double-blind Prevention

Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal Women

Endometrial Hyperplasia · Osteoporosis

Bottom Line

View on ClinicalTrials.gov: NCT00242710 ↗

Enrolled (actual)

1,083

Serious AEs

5.2%

Results posted

Dec 2013

Primary outcome: Primary: Percentage of Participants With Hyperplasia at Screening

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Bazedoxifene/Conjugated Estrogen (Drug); CE 0.45 mg/MPA 1.5mg (Drug); Placebo (Other)
Age: Adult, Older Adult · 40+ yrs
Sex: Female
Sponsor: Pfizer
Primary completion: Sep 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Hyperplasia at Screening	—	—
PRIMARY Percentage of Participants With Hyperplasia at Month 12	0.00; 1.10; 0.00; 0.00	—
PRIMARY Bone Mineral Density (BMD) of Lumbar Spine at Screening	1.00; 1.01; 1.02; 1.01	—
PRIMARY Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12	0.80; 0.80; 2.22; -1.56	<0.001 sig
PRIMARY Bone Mineral Density (BMD) of Total Hip at Screening	0.90; 0.89; 0.90; 0.89	—
PRIMARY Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 12	0.62; 0.84; 1.47; -0.99	<0.001 sig
SECONDARY Percentage of Days With Breast Pain	1.55; 1.22; 3.49; 0.89; 1.71; 1.58	0.373
SECONDARY Percentage of Participants With Uterine Bleeding or Spotting	5.45; 4.15; 19.50; 4.52; 2.19; 2.86	0.826
SECONDARY Percentage of Participants With Hyperplasia at Month 24	0.00; 4.93; 0.00; 0.00	—
SECONDARY Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 24	0.96; 0.86; 2.39; -2.29	<0.001 sig
SECONDARY Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 24	0.30; 0.41; 0.85; -1.53	<0.001 sig

Summary

The purpose of this study is to determine whether bazedoxifene/conjugated estrogens combinations are effective for the prevention of endometrial hyperplasia and for the prevention of osteoporosis in postmenopausal women.

Eligibility Criteria

Inclusion Criteria

Generally healthy, postmenopausal women, aged 40 to less than 65 years
Intact uterus
At least 12 months of spontaneous amenorrhea, OR 6 months spontaneous amenorrhea with follicle-stimulating hormone (FSH) levels > 40 mIU/mL.

Exclusion Criteria

Use of oral estrogen-, progestin-, androgen-, or SERM-containing drug products within 8 weeks before screening (12 weeks for the osteoporosis substudy)
A history or active presence of clinically important medical disease
Malabsorption disorders

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00242710). 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.