Effects of Fulvestrant on the Endometrium in Postmenopausal Women
Author Information
Author(s): Addo S, Yates R A, Laight A
Primary Institution: AstraZeneca Pharmaceuticals
Hypothesis
Does fulvestrant, an oestrogen receptor antagonist, affect the endometrium in healthy postmenopausal women?
Conclusion
Fulvestrant significantly inhibits oestrogen-stimulated thickening of the endometrium without showing agonist activity.
Supporting Evidence
- Fulvestrant at a dose of 250 mg significantly inhibited the oestrogen-stimulated thickening of the endometrium compared with placebo.
- Neither the 125 mg nor 250 mg doses of fulvestrant demonstrated oestrogenic effects on the endometrium over the initial 14-day assessment period.
- Fulvestrant was well tolerated and reduced the incidence of ethinyloestradiol-related side effects.
Takeaway
This study tested a new drug called fulvestrant to see if it helps prevent thickening of the uterus in women who have gone through menopause, and it worked well without causing side effects.
Methodology
This was a double-blind, randomised, parallel-group trial where 30 postmenopausal women received either fulvestrant or placebo, and their endometrial thickness was measured at various intervals.
Potential Biases
There may be potential bias due to the single-centre design and the nature of the randomisation.
Limitations
The study was limited to a small sample size and short duration.
Participant Demographics
All participants were healthy postmenopausal women aged between 45 and 60 years.
Statistical Information
P-Value
0.0001
Statistical Significance
p=0.0001
Digital Object Identifier (DOI)
Want to read the original?
Access the complete publication on the publisher's website