Endometrial effects of a 91-day extended-regimen oral contraceptive with low-dose estrogen in place of placebo.

BACKGROUND: The study was conducted to evaluate the effects of a 91-day extended-regimen oral contraceptive (OC) containing levonorgestrel (LNG) with low-dose ethinyl estradiol (EE) in place of placebo on endometrial histology. STUDY DESIGN: Endometrial biopsies were obtained prior to initiation and posttreatment, between cycle Days 60 and 84 (during combination EE/LNG tablets), between cycle Days 85 and 91 (during low-dose EE tablets) or after completion of therapy. RESULTS: Paired endometrial biopsy samples obtained before and after treatment were available for 63 subjects. Biopsy results demonstrated that this OC regimen did not promote unexpected changes in the endometrium, either during the course of active treatment with EE/LNG or during the 7-day low-dose EE interval. Endometrial hyperplasia or malignancy was not observed in any endometrial biopsy sample. CONCLUSION: Use of a 91-day extended-regimen OC with low-dose EE in place of placebo was not associated with any untoward effects on the endometrium.

Safety and efficacy of an extended-regimen oral contraceptive utilizing continuous low-dose ethinyl estradiol.

OBJECTIVE: To assess the efficacy and safety of Seasonique, a 91-day extended-regimen oral contraceptive (OC) utilizing continuous low-dose ethinyl estradiol (EE) during the typical hormone-free interval. METHODS: A multicenter, open-label, 1-year study of Seasonique [30 microg EE/150 microg levonorgestrel (LNG)] for 84 days followed by EE 10 microg for 7 days was conducted in sexually active, adult women of childbearing potential. All patients completed daily electronic diaries to monitor compliance and bleeding. RESULTS: Method failure rate was 0.78 (Pearl index) and 0.64% (life table analysis). Cycle control and safety of the regimen were similar to that reported for other OCs. CONCLUSION: This study demonstrates that Seasonique is effective, safe and well tolerated for the prevention of pregnancy.

Endometrial microstructure after long-term use of a 91-day extended-cycle oral contraceptive regimen.

OBJECTIVE: To assess the effect on the endometrial microstructure of an extended-cycle oral contraceptive (OC) regimen containing ethinyl estradiol (EE) and levonorgestrel (LNG). METHODOLOGY: Subjects received up to four cycles of a 91-day extended-cycle OC regimen (84 consecutive days of monophasic 30 microg EE/150 microg LNG followed by 7 days of placebo). Endometrial biopsies were performed prior to the initiation and at the completion of therapy. All endometrial samples were processed centrally and reviewed by three independent pathologists blinded to treatment groups. RESULTS: Endometrial biopsies were performed in 50 women. In general, samples taken after completion of therapy with no further hormonal exposure demonstrated rapid return to normal endometrial cycling. In contrast, the majority of subjects still on active extended hormonal OC therapy at the time of biopsy had inactive or atrophic endometrium. No intravascular blood clots were observed in any of the specimens. CONCLUSION: The endometrial findings observed in this cohort of women treated with a 91-day extended-cycle OC regimen for up to 1 year showed no significant pathology. Additionally, the endometrium reverted quickly to normal cyclic changes in those subjects who, after completing therapy, elected not to continue with hormonal contraception.