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A historical cycle control comparison of two drospirenone-containing combined oral contraceptives: ethinylestradiol 30 μg/drospirenone 3 mg administered in a 21/7 regimen versus ethinylestradiol 20 μg/drospirenone 3 mg administered in a 24/4 regimen.

Abstract

OBJECTIVES

To compare the bleeding patterns and cycle control of an oral contraceptive (OC) containing ethinylestradiol (EE) 30 μg/drospirenone (drsp) 3mg administered in a 21/7 regimen versus a lower-dose OC containing EE 20 μg/drsp 3mg administered in a 24/4 regimen, using data from two identically designed studies.

MATERIALS AND METHODS

In the first study, 326 healthy women (18-35 years) received EE 30 μg/drsp 3mg in a 21/7 regimen. In the second study, 1027 healthy women (17-36 years) received EE 20 μg/drsp 3mg in a 24/4 regimen. Participants recorded bleeding using daily completed diaries over 13 treatment cycles.

RESULTS

During cycles 1-12, the prevalence of scheduled withdrawal bleeding was lower with EE 20 μg/drsp 3mg 24/4 than with EE 30 μg/drsp 3mg 21/7 (82.0-91.7% versus 94.8-100.0% of women, respectively); moreover, a higher proportion of women reported a maximum intensity of light scheduled withdrawal bleeding with EE 20 μg/drsp 3mg 24/4 than with EE 30 μg/drsp 3mg 21/7 (30.9-39.0% versus 13.8-20.5% of women, respectively). In cycles 2-13, unscheduled intracyclic bleeding was reported by 7.7-13.8% of EE 20 μg/drsp 3mg 24/4 recipients and 3.8-7.9% of EE 30 μg/drsp 3mg 21/7 recipients; these were mainly single bleeding days. During reference periods 1-4, the mean number of bleeding episodes was similar between groups (3.1-3.3 episodes with EE 20 μg/drsp 3mg 24/4 versus 3.2 episodes with EE 30 μg/drsp 3mg 21/7).

CONCLUSIONS

A low-dose 24/4 regimen OC containing EE 20 μg/drsp 3mg is generally comparable in terms of bleeding to a higher-dose 21/7 regimen OC containing EE30 μg/drsp 3mg. Between-treatment differences in bleeding intensity and unscheduled intracyclic bleeding rates were observed.

Authors+Show Affiliations

Global Clinical Development, Women's Healthcare, Bayer HealthCare Pharmaceuticals, Berlin, Germany. joachim.marr@bayer.comNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22391750

Citation

Marr, Joachim, et al. "A Historical Cycle Control Comparison of Two Drospirenone-containing Combined Oral Contraceptives: Ethinylestradiol 30 Μg/drospirenone 3 Mg Administered in a 21/7 Regimen Versus Ethinylestradiol 20 Μg/drospirenone 3 Mg Administered in a 24/4 Regimen." European Journal of Obstetrics, Gynecology, and Reproductive Biology, vol. 162, no. 1, 2012, pp. 91-5.
Marr J, Gerlinger C, Kunz M. A historical cycle control comparison of two drospirenone-containing combined oral contraceptives: ethinylestradiol 30 μg/drospirenone 3 mg administered in a 21/7 regimen versus ethinylestradiol 20 μg/drospirenone 3 mg administered in a 24/4 regimen. Eur J Obstet Gynecol Reprod Biol. 2012;162(1):91-5.
Marr, J., Gerlinger, C., & Kunz, M. (2012). A historical cycle control comparison of two drospirenone-containing combined oral contraceptives: ethinylestradiol 30 μg/drospirenone 3 mg administered in a 21/7 regimen versus ethinylestradiol 20 μg/drospirenone 3 mg administered in a 24/4 regimen. European Journal of Obstetrics, Gynecology, and Reproductive Biology, 162(1), pp. 91-5. doi:10.1016/j.ejogrb.2012.01.021.
Marr J, Gerlinger C, Kunz M. A Historical Cycle Control Comparison of Two Drospirenone-containing Combined Oral Contraceptives: Ethinylestradiol 30 Μg/drospirenone 3 Mg Administered in a 21/7 Regimen Versus Ethinylestradiol 20 Μg/drospirenone 3 Mg Administered in a 24/4 Regimen. Eur J Obstet Gynecol Reprod Biol. 2012;162(1):91-5. PubMed PMID: 22391750.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A historical cycle control comparison of two drospirenone-containing combined oral contraceptives: ethinylestradiol 30 μg/drospirenone 3 mg administered in a 21/7 regimen versus ethinylestradiol 20 μg/drospirenone 3 mg administered in a 24/4 regimen. AU - Marr,Joachim, AU - Gerlinger,Christoph, AU - Kunz,Michael, Y1 - 2012/03/04/ PY - 2011/03/01/received PY - 2012/01/03/revised PY - 2012/01/30/accepted PY - 2012/3/7/entrez PY - 2012/3/7/pubmed PY - 2012/8/21/medline SP - 91 EP - 5 JF - European journal of obstetrics, gynecology, and reproductive biology JO - Eur. J. Obstet. Gynecol. Reprod. Biol. VL - 162 IS - 1 N2 - OBJECTIVES: To compare the bleeding patterns and cycle control of an oral contraceptive (OC) containing ethinylestradiol (EE) 30 μg/drospirenone (drsp) 3mg administered in a 21/7 regimen versus a lower-dose OC containing EE 20 μg/drsp 3mg administered in a 24/4 regimen, using data from two identically designed studies. MATERIALS AND METHODS: In the first study, 326 healthy women (18-35 years) received EE 30 μg/drsp 3mg in a 21/7 regimen. In the second study, 1027 healthy women (17-36 years) received EE 20 μg/drsp 3mg in a 24/4 regimen. Participants recorded bleeding using daily completed diaries over 13 treatment cycles. RESULTS: During cycles 1-12, the prevalence of scheduled withdrawal bleeding was lower with EE 20 μg/drsp 3mg 24/4 than with EE 30 μg/drsp 3mg 21/7 (82.0-91.7% versus 94.8-100.0% of women, respectively); moreover, a higher proportion of women reported a maximum intensity of light scheduled withdrawal bleeding with EE 20 μg/drsp 3mg 24/4 than with EE 30 μg/drsp 3mg 21/7 (30.9-39.0% versus 13.8-20.5% of women, respectively). In cycles 2-13, unscheduled intracyclic bleeding was reported by 7.7-13.8% of EE 20 μg/drsp 3mg 24/4 recipients and 3.8-7.9% of EE 30 μg/drsp 3mg 21/7 recipients; these were mainly single bleeding days. During reference periods 1-4, the mean number of bleeding episodes was similar between groups (3.1-3.3 episodes with EE 20 μg/drsp 3mg 24/4 versus 3.2 episodes with EE 30 μg/drsp 3mg 21/7). CONCLUSIONS: A low-dose 24/4 regimen OC containing EE 20 μg/drsp 3mg is generally comparable in terms of bleeding to a higher-dose 21/7 regimen OC containing EE30 μg/drsp 3mg. Between-treatment differences in bleeding intensity and unscheduled intracyclic bleeding rates were observed. SN - 1872-7654 UR - https://www.unboundmedicine.com/medline/citation/22391750/A_historical_cycle_control_comparison_of_two_drospirenone_containing_combined_oral_contraceptives:_ethinylestradiol_30_μg/drospirenone_3_mg_administered_in_a_21/7_regimen_versus_ethinylestradiol_20_μg/drospirenone_3_mg_administered_in_a_24/4_regimen_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0301-2115(12)00064-4 DB - PRIME DP - Unbound Medicine ER -