Effects of oral contraceptives containing ethinylestradiol with either drospirenone or levonorgestrel on various parameters associated with well-being in healthy women: a randomized, single-blind, parallel-group, multicentre study.
BACKGROUND
The combined oral contraceptive Yasmin (drospirenone 3 mg plus ethinylestradiol 30 microg [DRSP 3 mg/EE 30 microg]) has been shown to be a well tolerated and effective combination that provides high contraceptive reliability and good cycle control. Furthermore, DRSP 3 mg/EE 30 microg has been shown to have a positive effect on premenstrual symptoms and well-being/health-related quality of life, and to improve the skin condition of women with acne. To date, however, there have been relatively few studies that have compared the effects of DRSP 3 mg/EE 30 microg on the general well-being of women with those of other oral contraceptives.


OBJECTIVE
To compare the impact of DRSP 3 mg/EE 30 microg with that of levonorgestrel 150 microg/EE 30 microg (LNG 150 microg/EE 30 microg; Microgynon 30) on various parameters associated with well-being in healthy female subjects.


METHODS
This was a randomized, single-blind, parallel-group, multicentre study conducted using 21/7-day regimens of DRSP 3 mg/EE 30 microg and LNG 150 microg/EE 30 microg over seven cycles. Efficacy parameters included: changes in Menstrual Distress Questionnaire (MDQ) normative T scores; the proportion of subjects with acne; and menstrual symptoms. Cycle control and subjective well-being parameters were also assessed.


RESULTS
Treatment with DRSP 3 mg/EE 30 microg had similar beneficial effects on symptoms of water retention and impaired concentration to LNG 150 microg/EE 30 microg, but was significantly better in alleviating negative affect symptoms during the menstrual phase (median difference in MDQ T score -3; p = 0.027; Wilcoxon rank sum test). The proportion of subjects with acne decreased from approximately 55% to approximately 45% in the DRSP 3 mg/EE 30 microg group, but remained static at approximately 60% in the LNG 150 microg/EE 30 microg group. Somatic and psychological symptoms occurred at the greatest intensity and for most subjects during the menstrual phase of the cycle in both groups.


CONCLUSIONS
Both drugs had similar cycle control parameters with a tendency towards reduced bleeding with continued use. More subjects in the DRSP 3 mg/EE 30 microg group reported improved physical well-being (60% vs 46%; p = 0.035; chi-squared [chi2] test). Emotional well-being was reported improved in 61% and 51% of DRSP 3 mg/EE 30 microg and LNG 150 microg/EE 30 microg users, respectively (p = 0.1190; chi2 test). Adverse events were typical of oral contraceptive use and did not give rise to any safety concerns. Both products had similar beneficial effects on symptoms of water retention and impaired concentration, but DRSP 3 mg/EE 30 microg was significantly better in alleviating negative affect symptoms during the menstrual phase. The proportion of subjects with acne decreased in the DRSP 3 mg/EE 30 microg group but not in the LNG 150 microg/EE 30 microg group. More subjects in the DRSP 3 mg/EE 30 microg group reported improved physical well-being compared with the LNG 150 microg/EE 30 microg group.
Kelly
Sue
S
Connaught Clinical Consulting, Sydney, New South Wales, Australia.
Davies
Emyr
E
Fearns
Simon
S
McKinnon
Carol
C
Carter
Rick
R
Gerlinger
Christoph
C
Smithers
Andrew
A
D000293:Adolescent; D000328:Adult; D000736:Androstenes / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D001834:Body Water / Q000187:drug effects; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D004338:Drug Combinations; D004997:Ethinyl Estradiol / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D005260:Female; D006801:Humans; D016912:Levonorgestrel / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D008597:Menstrual Cycle / Q000187:drug effects; D011788:Quality of Life; D016037:Single-Blind Method; D018709:Statistics, Nonparametric; D055815:Young Adult
D000736:Androstenes; D003277:Contraceptives, Oral, Combined; D004338:Drug Combinations; C534342:drospirenone and ethinyl estradiol combination; C072593:ethinyl estradiol, levonorgestrel drug combination; D004997:Ethinyl Estradiol; D016912:Levonorgestrel
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