Abstract
Objectives
Traditional progestogen-only pills (POPs) have stringent daily timing and missed pill
rules that might affect contraceptive reliability. A new-generation oestrogen-free
pill has been developed, containing 4-mg drospirenone with a unique regimen of 24
active treatment days followed by four placebo tablets. A previous study showed that
this new drospirenone-only pill effectively inhibited ovulation. Clinical efficacy,
however, can be affected by compliance, and delayed or forgotten pill intake often
occurs in daily life. The aim of this study was to investigate if inhibition of ovulation
was maintained after four scheduled 24-h delays in tablet intake.
Study design
One hundred thirty healthy women with proven ovulatory cycles were randomized, and
127 were treated with the drospirenone-only pill during two cycles. In treatment Group
A (n=62), 24-h delays in tablet intake were scheduled on days 3, 6, 11 and 22 during Cycle
2 and, in treatment Group B (n=65) during Cycle 1, respectively. Ovulation was defined as disappearance or persistence of a large follicle and progesterone
levels higher than 5 ng/mL for at least 5 consecutive days.
Results
The overall ovulation rate was 0.8%; only one subject in Group A fulfilled the ovulation
criteria in Cycle 2. Follicular diameters in the regular-intake and the delayed-intake
cycles were similar.
Conclusion
Despite the 4-day hormone-free period and multiple intentional 24-h delays in tablet
intake, ovulation inhibition was maintained. This property distinguishes this new-generation
oestrogen-free pill from traditional POPs by allowing the same “safety window” or
flexibility in intake as combined oral contraceptives without compromising contraceptive
reliability.
Implications
Delayed or forgotten pill intake is very common. Ovulation inhibition by the new-generation
oestrogen-free pill, containing 4-mg drospirenone for 24 days followed by a 4-day treatment-free period, was maintained despite four 24-h delays
in tablet intake, so the impact of delayed intake on contraceptive reliability will
be low.
Keywords
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Article info
Publication history
Published online: December 17, 2015
Accepted:
December 11,
2015
Received in revised form:
December 10,
2015
Received:
July 8,
2015
Footnotes
☆Funding: The study was funded by Exeltis.
☆☆Conflict of interest: D. Drouin is employee of Exeltis France. E.Colli is employee of Exeltis Spain. D. Heger-Mahn and I. Duijkers are directors of Dinox, a contract research organization that received funding from Exeltis to perform the study. S. Skouby is consultant for manufacturers of hormonal products including contraceptives and postmenopausal therapy.
☆☆☆Clinical trial registration number: EudraCT 2013–001,513-33.
Identification
Copyright
© 2016 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
