Multicenter clinical trial on the efficacy and acceptability of a single contraceptive implant of nomegestrol acetate, Uniplant

被引:33
作者
Coutinho, EM
deSouza, JC
Athayde, C
Barbosa, IC
Alvarez, F
Brache, V
Gu, ZP
Emuveyan, EE
Adekunle, AO
Devoto, L
Shaaban, MM
Salem, HT
Affandi, B
deAcosta, OM
Mati, J
Ladipo, OA
机构
[1] PROFAMILIA,SANTO DOMINGO,DOMINICAN REP
[2] SHANGHAI INST MAT MED,SHANGHAI,PEOPLES R CHINA
[3] UNIV LAGOS,COLL MED,DEPT OBSTET & GYNECOL,LAGOS,NIGERIA
[4] UNIV IBADAN,UNIV COLL HOSP,DEPT OBSTET & GYNECOL,IBADAN,NIGERIA
[5] UNIV CHILE,FAC MED,DEPT OBSTET & GYNECOL,SANTIAGO 7,CHILE
[6] UNIV ASSIUT,SCH MED,DEPT OBSTET & GYNECOL,ASSIUT,EGYPT
[7] UNIV INDONESIA,FAC MED,DEPT OBSTET & GYNECOL,JAKARTA,INDONESIA
[8] INST NACL ENDOCRINOL,HAVANA,CUBA
[9] KENYA GOVT MED RES CTR,REPROD HLTH RES UNIT,NAIROBI,KENYA
[10] SOUTH SOUTH COOPERAT REPROD HLTH,SALVADOR,BA,BRAZIL
关键词
single contraceptive implant Uniplant;
D O I
10.1016/0010-7824(95)00263-4
中图分类号
R71 [妇产科学];
学科分类号
100211 ;
摘要
Uniplant, a single Silastic implant containing nomegestrol acetate, provides contraceptive efficacy for one year. Uniplant use for one year was studied in 1,803 healthy women of reproductive age, enrolled from 10 centers in 9 countries, after informed consent. Implants were placed subdermally either in the upper arm or in the gluteal region. Two-hundred-seventy-six subjects discontinued prior to completing one year of study. Cumulative discontinuation rate at 12 months was 15.72%. Medical reasons for discontinuation were principally menstrual-related. Fifteen pregnancies occurred during the one year study period, resulting in a 12-month net cumulative pregnancy rate of 0.94%. Approximately 56% of subjects using Uniplant had bleeding patterns similar to normal menstruation. Results from this study confirm that Uniplant is an efficient, well tolerated, 12-month contraceptive implant, with the advantage of easier insertion and removal of the single implant compared to other multiple implant methods.
引用
收藏
页码:121 / 125
页数:5
相关论文
共 7 条
  • [1] EFFECT OF NOMEGESTROL ACETATE, A NEW 19-NOR-PROGESTERONE DERIVATIVE, ON PITUITARY-OVARIAN FUNCTION IN WOMEN
    BAZIN, B
    THEVENOT, R
    BURSAUX, C
    PARIS, J
    [J]. BRITISH JOURNAL OF OBSTETRICS AND GYNAECOLOGY, 1987, 94 (12): : 1199 - 1204
  • [3] ONE-YEAR EXPERIENCE WITH SUBDERMAL CONTRACEPTIVE IMPLANTS IN THE UNITED-STATES
    FRANK, ML
    POINDEXTER, AN
    CORNIN, LM
    COX, CA
    BATEMAN, L
    [J]. CONTRACEPTION, 1993, 48 (03) : 229 - 243
  • [4] BLOOD-PRESSURE AND CONTRACEPTIVE USE
    KHAW, KT
    PEART, WS
    [J]. BRITISH MEDICAL JOURNAL, 1982, 285 (6339) : 403 - 407
  • [5] THE USE OF LEVONORGESTREL IMPLANTS (NORPLANT) FOR CONTRACEPTION IN ADOLESCENT MOTHERS
    POLANECZKY, M
    SLAP, G
    FORKE, C
    RAPPAPORT, A
    SONDHEIMER, S
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 1994, 331 (18) : 1201 - 1206
  • [6] 1990, MANAGERIAL TECHNICAL
  • [7] MENSTRUAL DIARY ANAL