Occurrence of menses or pregnancy after cessation of a continuous oral contraceptive.
OBJECTIVE
To evaluate the time to return to spontaneous menses in women after 1 year of daily continuous levonorgestrel (LNG) 90 microg/ethinyl E(2) (EE) 20 microg.


METHODS
Observational study.


METHODS
Gynecologic and primary care practices.


METHODS
Women aged 18-49 years with a history of regular menstrual cycles. After participation in an open-label, continuous oral contraceptive (OC) trial for at least 6 months, participants agreed to enroll in a separate study of the return to menses or pregnancy.


METHODS
None.


METHODS
Time to return to spontaneous menses or pregnancy.


RESULTS
The 198 subjects had a mean age of 30.4 +/- 6.6 years with 72% white, 13% Hispanic, and 7% African American. The mean duration of continuous LNG/EE treatment before enrollment was 349 +/- 41 days. Of the 187 (94%) subjects who completed this study, 181 returned to spontaneous menses and 4 became pregnant within 90 days after the last dose of LNG 90 microg/EE 20 microg. The median time to return to menses in the completer population was 32 days, and the incidence of spontaneous menses or pregnancy at day < or = 90 was 98.9%. The duration of amenorrhea during continuous LNG/EE use before stopping treatment was unrelated to the time to the return to menses.


CONCLUSIONS
Spontaneous menses or pregnancy occurred in 98.9% of women after cessation of continuous LNG/EE.
Davis
Anne R
AR
College of Physicians & Surgeons, Department OB/GYN, Columbia University, New York, New York. Electronic address: ard4@columbia.edu.
Kroll
Robin
R
Women's Clinical Research Center, Seattle, Washington.
Soltes
Barbara
B
Center for Women's Research, Chicago, Illinois.
Zhang
Nan
N
Wyeth Research, Collegeville, Pennsylvania.
Grubb
Gary S
GS
Wyeth Research, Collegeville, Pennsylvania.
Constantine
Ginger D
GD
Wyeth Research, Collegeville, Pennsylvania.
D000293:Adolescent; D000328:Adult; D003280:Contraceptives, Oral, Synthetic / Q000009:adverse effects / Q000494:pharmacology*; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D004967:Estrogens / Q000009:adverse effects / Q000494:pharmacology*; D004997:Ethinyl Estradiol / Q000009:adverse effects / Q000494:pharmacology*; D005260:Female; D005298:Fertility / Q000187:drug effects* / Q000502:physiology; D005500:Follow-Up Studies; D006801:Humans; D007030:Hypothalamo-Hypophyseal System / Q000187:drug effects / Q000502:physiology; D016912:Levonorgestrel / Q000009:adverse effects / Q000494:pharmacology*; D008598:Menstruation / Q000187:drug effects* / Q000502:physiology; D008875:Middle Aged; D010053:Ovary / Q000187:drug effects / Q000502:physiology; D011247:Pregnancy; D012044:Regression Analysis; D013997:Time Factors
D003280:Contraceptives, Oral, Synthetic; D004967:Estrogens; D004997:Ethinyl Estradiol; D016912:Levonorgestrel