Tags

Type your tag names separated by a space and hit enter

Cycle control with a 21-day compared with a 24-day oral contraceptive pill: a randomized controlled trial.
Obstet Gynecol. 2009 Dec; 114(6):1205-12.OG

Abstract

OBJECTIVE

To compare bleeding patterns between a 21/7-day triphasic norgestimate/ethinyl estradiol (E2) 25-microgram oral contraceptive pill (OCP) and a 24/4-day drospirenone/ethinyl E2 20-microgram OCP.

METHODS

In a three-cycle, open-label, multicenter study, healthy, sexually active women were assigned randomly to a 21/7-day (norgestimate/ethinyl E2) or 24/4-day (drospirenone/ethinyl E2) OCP regimen. Randomization was stratified to assure a balanced distribution between regimens for "fresh starts" and "switchers." Bleeding data were collected daily using an interactive voice-response system. Bleeding was defined according to the 2007 U.S. Food and Drug Administration's Reproductive Health Drug Advisory Committee-endorsed criteria.

RESULTS

Across the three cycles, the 21/7-day OCP group (n=165) reported fewer unscheduled bleeding days than did the 24/4-day OCP group (n=167) (mean 4.6 compared with 6.1 days, P=.003). Women using the 21/7-day OCP had significantly fewer episodes of unscheduled bleeding than did those using the 24/4-day OCP (mean 1.47 compared with 2.01, P=.001). Moreover, women using the 21/7-day OCP had a significantly lower absence of scheduled bleeding at each cycle (P<.001). Both regimens were well-tolerated.

CONCLUSION

A 21-day norgestimate/ethinyl E2 25-microgram regimen results in less unscheduled bleeding and more scheduled bleeding than does a 24-day drospirenone/ethinyl E2 20-microgram regimen.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov, www.ClinicalTrials.gov, NCT00745901.

LEVEL OF EVIDENCE

I.

Authors+Show Affiliations

Department of Obstetrics and Gynecology, University of Florida College of Medicine, Jacksonville, Florida, USA. andrew.kaunitz@jax.ufl.eduNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

19935020

Citation

Kaunitz, Andrew M., et al. "Cycle Control With a 21-day Compared With a 24-day Oral Contraceptive Pill: a Randomized Controlled Trial." Obstetrics and Gynecology, vol. 114, no. 6, 2009, pp. 1205-12.
Kaunitz AM, Burkman RT, Fisher AC, et al. Cycle control with a 21-day compared with a 24-day oral contraceptive pill: a randomized controlled trial. Obstet Gynecol. 2009;114(6):1205-12.
Kaunitz, A. M., Burkman, R. T., Fisher, A. C., & Laguardia, K. D. (2009). Cycle control with a 21-day compared with a 24-day oral contraceptive pill: a randomized controlled trial. Obstetrics and Gynecology, 114(6), 1205-12. https://doi.org/10.1097/AOG.0b013e3181beab47
Kaunitz AM, et al. Cycle Control With a 21-day Compared With a 24-day Oral Contraceptive Pill: a Randomized Controlled Trial. Obstet Gynecol. 2009;114(6):1205-12. PubMed PMID: 19935020.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Cycle control with a 21-day compared with a 24-day oral contraceptive pill: a randomized controlled trial. AU - Kaunitz,Andrew M, AU - Burkman,Ronald T, AU - Fisher,Alan C, AU - Laguardia,Katherine D, PY - 2009/11/26/entrez PY - 2009/11/26/pubmed PY - 2009/12/22/medline SP - 1205 EP - 12 JF - Obstetrics and gynecology JO - Obstet Gynecol VL - 114 IS - 6 N2 - OBJECTIVE: To compare bleeding patterns between a 21/7-day triphasic norgestimate/ethinyl estradiol (E2) 25-microgram oral contraceptive pill (OCP) and a 24/4-day drospirenone/ethinyl E2 20-microgram OCP. METHODS: In a three-cycle, open-label, multicenter study, healthy, sexually active women were assigned randomly to a 21/7-day (norgestimate/ethinyl E2) or 24/4-day (drospirenone/ethinyl E2) OCP regimen. Randomization was stratified to assure a balanced distribution between regimens for "fresh starts" and "switchers." Bleeding data were collected daily using an interactive voice-response system. Bleeding was defined according to the 2007 U.S. Food and Drug Administration's Reproductive Health Drug Advisory Committee-endorsed criteria. RESULTS: Across the three cycles, the 21/7-day OCP group (n=165) reported fewer unscheduled bleeding days than did the 24/4-day OCP group (n=167) (mean 4.6 compared with 6.1 days, P=.003). Women using the 21/7-day OCP had significantly fewer episodes of unscheduled bleeding than did those using the 24/4-day OCP (mean 1.47 compared with 2.01, P=.001). Moreover, women using the 21/7-day OCP had a significantly lower absence of scheduled bleeding at each cycle (P<.001). Both regimens were well-tolerated. CONCLUSION: A 21-day norgestimate/ethinyl E2 25-microgram regimen results in less unscheduled bleeding and more scheduled bleeding than does a 24-day drospirenone/ethinyl E2 20-microgram regimen. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.ClinicalTrials.gov, NCT00745901. LEVEL OF EVIDENCE: I. SN - 1873-233X UR - https://www.unboundmedicine.com/medline/citation/19935020/Cycle_control_with_a_21_day_compared_with_a_24_day_oral_contraceptive_pill:_a_randomized_controlled_trial_ L2 - http://dx.doi.org/10.1097/AOG.0b013e3181beab47 DB - PRIME DP - Unbound Medicine ER -