Bleeding profile of a flexible extended regimen of ethinylestradiol/ drospirenone in US women: An open-label, three-arm, active-controlled, multicenter study

Jeffrey Jensen, Sona Grossova Garie, Dietmar Trummer, Jörg Elliesen

Research output: Contribution to journalArticle

33 Citations (Scopus)

Abstract

Background: Unscheduled bleeding may affect satisfaction and compliance with extended oral contraceptive (OC) regimens. The bleeding patterns of two variants of a flexible dosing regimen designed to manage intracyclic bleeding problems during extended cycles were compared with that of a conventional OC regimen. Study Design: This was a 1-year, open-label, active-controlled, Phase 3 study conducted in the USA. Healthy women (18-45 years) received an ethinylestradiol (EE) 20 mcg/drospirenone 3 mg OC in two flexible extended regimens or in a conventional 24/4 (i.e., 28-day) regimen. The primary regimen [management of intracyclic bleeding (flexibleMIB) regimen] was an extended dosing regimen that required subjects to initiate 4-day tablet-free intervals after 3 days of breakthrough bleeding/spotting. An alternative extended regimen [active period control (flexibleAPC) regimen] allowed subjects to initiate a 4-day tablet-free interval irrespective of the occurrence of bleeding. Bleeding profiles were compared between treatments. Efficacy and safety outcomes were also assessed. Results: The full analysis set comprised 1864 women (flexibleMIB, N=1406; flexibleAPC, N=232; conventional 24/4, N=226). Over 1 year, subjects in the flexible MIB group experienced significantly fewer (mean±SD, 40±30) bleeding/spotting days than those in the conventional 24/4 group (52±35). The corresponding value in the flexibleAPC group was 47±33 days. The pregnancy rate in the flexibleMIB group was 1.65 per 100 woman-years (95% confidence interval, 0.96-2.65). All three regimens were well tolerated. Conclusion: A flexibleMIB dosing regimen of EE 20 mcg/drospirenone 3 mg is associated with good contraceptive efficacy and fewer bleeding/spotting days than the conventional 24/4 regimen.

Original languageEnglish (US)
Pages (from-to)110-118
Number of pages9
JournalContraception
Volume86
Issue number2
DOIs
StatePublished - Aug 2012

Fingerprint

Ethinyl Estradiol
Multicenter Studies
Hemorrhage
Metrorrhagia
Oral Contraceptives
Tablets
drospirenone
Pregnancy Rate
Contraceptive Agents
Confidence Intervals
Safety

Keywords

  • Bleeding profile
  • Drospirenone
  • Efficacy
  • Ethinylestradiol
  • Flexible extended regimen
  • Safety

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology

Cite this

Bleeding profile of a flexible extended regimen of ethinylestradiol/ drospirenone in US women : An open-label, three-arm, active-controlled, multicenter study. / Jensen, Jeffrey; Garie, Sona Grossova; Trummer, Dietmar; Elliesen, Jörg.

In: Contraception, Vol. 86, No. 2, 08.2012, p. 110-118.

Research output: Contribution to journalArticle

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abstract = "Background: Unscheduled bleeding may affect satisfaction and compliance with extended oral contraceptive (OC) regimens. The bleeding patterns of two variants of a flexible dosing regimen designed to manage intracyclic bleeding problems during extended cycles were compared with that of a conventional OC regimen. Study Design: This was a 1-year, open-label, active-controlled, Phase 3 study conducted in the USA. Healthy women (18-45 years) received an ethinylestradiol (EE) 20 mcg/drospirenone 3 mg OC in two flexible extended regimens or in a conventional 24/4 (i.e., 28-day) regimen. The primary regimen [management of intracyclic bleeding (flexibleMIB) regimen] was an extended dosing regimen that required subjects to initiate 4-day tablet-free intervals after 3 days of breakthrough bleeding/spotting. An alternative extended regimen [active period control (flexibleAPC) regimen] allowed subjects to initiate a 4-day tablet-free interval irrespective of the occurrence of bleeding. Bleeding profiles were compared between treatments. Efficacy and safety outcomes were also assessed. Results: The full analysis set comprised 1864 women (flexibleMIB, N=1406; flexibleAPC, N=232; conventional 24/4, N=226). Over 1 year, subjects in the flexible MIB group experienced significantly fewer (mean±SD, 40±30) bleeding/spotting days than those in the conventional 24/4 group (52±35). The corresponding value in the flexibleAPC group was 47±33 days. The pregnancy rate in the flexibleMIB group was 1.65 per 100 woman-years (95{\%} confidence interval, 0.96-2.65). All three regimens were well tolerated. Conclusion: A flexibleMIB dosing regimen of EE 20 mcg/drospirenone 3 mg is associated with good contraceptive efficacy and fewer bleeding/spotting days than the conventional 24/4 regimen.",
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