PMID- 18555813 OWN - NLM STAT- MEDLINE DCOM- 20080922 LR - 20131121 IS - 0010-7824 (Print) IS - 0010-7824 (Linking) VI - 78 IP - 1 DP - 2008 Jul TI - Suppression of ovarian activity with a drospirenone-containing oral contraceptive in a 24/4 regimen. PG - 16-25 LID - 10.1016/j.contraception.2008.02.019 [doi] AB - BACKGROUND: This study was conducted to compare ovarian activity of an oral contraceptive containing drospirenone (drsp) 3 mg plus ethinylestradiol (EE) 20 mcg administered in 24/4 regimen compared with the conventional 21/7 regimen, during intended use and following predefined dosing errors. STUDY DESIGN: Women aged 18-35 years who ovulated or had a follicular diameter of >or=15 mm on or before Day 23 during a pretreatment cycle were admitted into this double-blind, randomized study. Participants underwent 3 treatment cycles with drsp 3 mg/EE 20 mcg in a 24/4 (n=52) or a 21/7 (n=52) regimen. In the third treatment cycle, the initial three pills in both groups were replaced with placebos. Ovarian activity was classified using the Hoogland scale during pretreatment and during Cycles 2 and 3. RESULTS: Suppression of ovarian activity was more pronounced with the 24/4 regimen--the odds ratio for a lower Hoogland score (i.e., greater ovarian suppression) with the 24/4 regimen compared with the conventional 21/7 regimen were 6.01 (95% CI: 2.29-17.94) and 3.06 (95% CI: 1.44-6.65) for Cycles 2 and 3, respectively. More women in the 24/4 regimen group had no ovarian activity 87.8% vs. 56.0% during Cycle 2 and 55.1% vs. 30.0% during Cycle 3. The 24/4 regimen was associated with a more consistent suppression (less fluctuation) of endogenous estradiol. CONCLUSION: The drsp 3 mg/EE 20 mcg oral contraceptive in a 24/4 regimen was associated with greater ovarian suppression (despite intentional dosing error), which results in decreased hormonal fluctuations, and may increase contraceptive efficacy with the low-dose formulation. FAU - Klipping, Christine AU - Klipping C AD - Dinox BV, 9713 GZ Groningen, The Netherlands. FAU - Duijkers, Ingrid AU - Duijkers I FAU - Trummer, Dietmar AU - Trummer D FAU - Marr, Joachim AU - Marr J LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20080527 PL - United States TA - Contraception JT - Contraception JID - 0234361 RN - 0 (Androstenes) RN - 0 (Contraceptives, Oral, Combined) RN - 423D2T571U (Ethinyl Estradiol) RN - 4TI98Z838E (Estradiol) RN - N295J34A25 (drospirenone) SB - IM EIN - Contraception. 2008 Oct;78(4):350 MH - Adolescent MH - Adult MH - Androstenes/*pharmacology MH - Confidence Intervals MH - *Contraceptives, Oral, Combined MH - Dose-Response Relationship, Drug MH - Double-Blind Method MH - Drug Administration Schedule MH - Estradiol/*blood/metabolism MH - Ethinyl Estradiol/*pharmacology MH - Female MH - Humans MH - Odds Ratio MH - Ovary/*drug effects/physiology MH - Treatment Outcome EDAT- 2008/06/17 09:00 MHDA- 2008/09/23 09:00 CRDT- 2008/06/17 09:00 PHST- 2007/04/27 00:00 [received] PHST- 2008/02/21 00:00 [revised] PHST- 2008/02/22 00:00 [accepted] PHST- 2008/06/17 09:00 [pubmed] PHST- 2008/09/23 09:00 [medline] PHST- 2008/06/17 09:00 [entrez] AID - S0010-7824(08)00110-8 [pii] AID - 10.1016/j.contraception.2008.02.019 [doi] PST - ppublish SO - Contraception. 2008 Jul;78(1):16-25. doi: 10.1016/j.contraception.2008.02.019. Epub 2008 May 27.