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Efficacy and safety of a levonorgestrel enteric-coated tablet as an over-the-counter drug for emergency contraception: a Phase IV clinical trial
Oleh:
Chen, Q.-J.
;
Xiang, W.-P.
;
Zhang, D.-K.
Jenis:
Article from Journal - ilmiah internasional
Dalam koleksi:
Human Reproduction vol. 26 no. 09 (Sep. 2011)
,
page 2316-2321..
Topik:
FERTILITY
;
Emergency Contraception
;
Levonorgestrel Enteric-Coated Tablet
;
Over-The-Counter Drug
;
Clinical Trial
Fulltext:
Hum. Reprod.-2011-Chen-2316-21.pdf
(152.27KB)
Ketersediaan
Perpustakaan FK
Nomor Panggil:
H07.K.2011.02
Non-tandon:
1 (dapat dipinjam: 0)
Tandon:
tidak ada
Lihat Detail Induk
Isi artikel
BACKGROUND An enteric-coated levonorgestrel emergency contraceptive pill (E-LNG-ECP) is an improved formulation, in terms of side effects, which both dissolves and is absorbed in the intestine. Our aim was to evaluate the efficacy and safety of E-LNG-ECP as an over-the-counter (OTC) drug for emergency contraception (EC) in Chinese women. METHODS A Phase IV clinical trial was conducted in five family planning clinics in China. Women seeking EC within 72 h after unprotected sexual intercourse or contraceptive failure who met the inclusion criteria were recruited. The efficacy of contraception (primary end-point was pregnancy rate), side effects (i.e. safety) and the value of E-LNG-ECP for EC were investigated. RESULTS Of 2445 women (aged 15–48 years) who took E-LNG-ECP with follow-up to determine pregnancy, only five pregnancies (0.2%) occurred. The efficacy of contraception was 95.3%. In total, 6.5% of women reported at least one adverse event after taking E-LNG-ECP, and no serious adverse events were reported. Only four subjects (0.16%) reported vomiting. The incidence of menstrual cycle disturbance was 20.1% after taking E-LNG-ECP. Subjects who had previously taken ECPs (54.4% of these women) rated the acceptability of E-LNG-ECP at 9.36 (on a 10-point scale) higher (P<0.05) than the rating of other LNG-EC pills taken previously. CONCLUSIONS The study found that E-LNG-ECP was effective, safe and well tolerated as an OTC drug. However, an randomized controlled trial should be performed to compare standard LNG tablets with E-LNG-ECP.
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