OBJECTIVE(S): To study the prevalence of persisting ovarian follicles and to assess the endometrial changes and patterns of vaginal bleeding over 1 year of use of a 20 micrograms/24 h levonorgestrel-releasing intracervical contraceptive device. DESIGN: Prospective, randomized study. SETTING:Two family planning clinics in Helsinki, Finland. PATIENT(S): Women requesting intrauterine hormonal contraception. INTERVENTION(S): Insertion of a levonorgestrel-releasing intracervical contraceptive device into the cervical canal (group 1, n = 151) or fundally into the uterine cavity (group 2, n = 147) for contraception. MAIN OUTCOME MEASURE(S): Transvaginal ultrasonography of the ovaries and endometrium at insertion and 3, 6, and 12 months after insertion. Data on bleeding were collected using menstrual diary cards. RESULTS:Persisting ovarian follicles were found in < 8% of women. In both groups, the amount of endometrial tissue decreased significantly in 3 months. The incidence of amenorrhea during the 1st year was higher in the fundal insertion group. CONCLUSION(S): The number of persisting follicles was low. Follicles resolved within 6 to 8 weeks. No association was found between persisting follicles and problems of bleeding. Compared with intracervical insertion, fundal insertion resulted in more uniform endometrial suppression and fewer days of bleeding and spotting.
RCT Entities:
OBJECTIVE(S): To study the prevalence of persisting ovarian follicles and to assess the endometrial changes and patterns of vaginal bleeding over 1 year of use of a 20 micrograms/24 h levonorgestrel-releasing intracervical contraceptive device. DESIGN: Prospective, randomized study. SETTING: Two family planning clinics in Helsinki, Finland. PATIENT(S): Women requesting intrauterine hormonal contraception. INTERVENTION(S): Insertion of a levonorgestrel-releasing intracervical contraceptive device into the cervical canal (group 1, n = 151) or fundally into the uterine cavity (group 2, n = 147) for contraception. MAIN OUTCOME MEASURE(S): Transvaginal ultrasonography of the ovaries and endometrium at insertion and 3, 6, and 12 months after insertion. Data on bleeding were collected using menstrual diary cards. RESULTS: Persisting ovarian follicles were found in < 8% of women. In both groups, the amount of endometrial tissue decreased significantly in 3 months. The incidence of amenorrhea during the 1st year was higher in the fundal insertion group. CONCLUSION(S): The number of persisting follicles was low. Follicles resolved within 6 to 8 weeks. No association was found between persisting follicles and problems of bleeding. Compared with intracervical insertion, fundal insertion resulted in more uniform endometrial suppression and fewer days of bleeding and spotting.