Efficacy and safety of a levonorgestrel enteric-coated tablet as an over-the-counter drug for emergency contraception: a Phase IV clinical trial

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 emergen...

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Bibliographic Details
Published in:Human reproduction (Oxford) 2011-09, Vol.26 (9), p.2316-2321
Main Authors: Chen, Q.-J., Xiang, W.-P., Zhang, D.-K., Wang, R.-P., Luo, Y.-F., Kang, J.-Z., Cheng, L.-N.
Format: Article
Language:English
Subjects:
Adolescent
Adult
Biological and medical sciences
China
Contraception, Postcoital - adverse effects
Contraception, Postcoital - methods
Female
Gynecology. Andrology. Obstetrics
Humans
Levonorgestrel - administration & dosage
Levonorgestrel - adverse effects
Levonorgestrel - therapeutic use
Medical sciences
Middle Aged
Nonprescription Drugs - administration & dosage
Nonprescription Drugs - adverse effects
Nonprescription Drugs - therapeutic use
Original
Pregnancy
Pregnancy Rate
Tablets, Enteric-Coated
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Summary: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
ISSN:0268-1161
1460-2350
DOI:10.1093/humrep/der181