Summary
Objective
The effects of estetrol (E4), a natural fetal estrogen, combined with drospirenone
(DRSP) were evaluated on plasma levels of sex hormone-binding globulin (SHBG), angiotensinogen
and 12 hemostasis markers.
Study design
Combinations of 3 mg DRSP with 5 or 10 mg E4 were compared with YAZ® (20 mcg ethinyl
estradiol and 3 mg DRSP; EE/DRSP) in parallel groups of 15–18 healthy young women.
Main outcome was the relative change from pretreatment to the end (day 24±1) of the
third treatment cycle.
Results
All E4 combinations showed low estrogen impact compared to EE/DRSP. Effects on SHBG
and angiotensinogen of 10 mg E4 combined with DRSP were 15%–20% that of EE/DRSP.
Both E4/DRSP combinations reduced D-dimer level and the 5 mg E4/DRSP combination also
decreased fragment 1+2.
Conclusions
The reduction in coagulation markers suggests an anticoagulant effect from DRSP.
The indications of a low thrombosis risk for E4 preparations should be validated in
larger studies.
Implication statement
- •The oral estrogens, 17-β-estradiol and ethinyl estradiol, are known for significant effects on estrogenic and hemostatic variables.
- •Effects of oral estetrol (E4) combined with drospirenone (DRSP) are significantly less for these variables.
- •This suggests a low procoagulant effect of E4/DRSP that should be clinically verified for low antithrombotic consequences.
Keywords
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Article info
Publication history
Published online: September 01, 2016
Accepted:
August 29,
2016
Received in revised form:
August 28,
2016
Received:
April 4,
2016
Footnotes
☆Conflict of interest: CKT and JN are employees of Good Biomarker Sciences and received financial support from Estetra for laboratory analysis and interpretation of data and drafting the manuscript; YZ and HCB are employees of Pantarhei Bioscience; MM and JMF are employees of Estetra; CKG and ID are employees of Dinox and received financial support from Estetra for the clinical part of the study. JMF is also a paid consultant for Mithra.
☆☆Clinical trial registration number: TC2102.
★This study was sponsored by Estetra SPRL, Rue Saint Georges 5, 4000 Liège, Belgium.
Identification
Copyright
© 2016 Elsevier Inc. All rights reserved.
