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Weight change and adverse event incidence with a low-dose oral contraceptive: two randomized, placebo-controlled trials.

Abstract：

:Changes in body weight and the incidence of estrogen-related side effects with low-dose oral contraceptives (OCs) containing 20 microg ethinyl estradiol (EE) have not been demonstrated in placebo-controlled trials. Two placebo-controlled, randomized trials demonstrated the efficacy of a low-dose OC for the treatment of acne in healthy females (n = 704; >or=14 years old) with regular menstrual cycles and moderate facial acne. Patients were randomized to receive 20 microg EE/100 microg levonorgestrel (LNG) or placebo for six cycles. Body weight was measured at baseline and during Cycles 1, 3, and 6. The occurrence of adverse events was recorded at each visit. Mean changes in weight from baseline were similar with 20 microg EE/100 microg LNG [0.72 kg +/- 2.64 (SD; n = 349)] and placebo [0.56 kg +/- 2.64 (SD; n = 355; p > 0.05)] for the last measured weight of each patient. Rates of headache, nausea, weight gain, and breast pain, side effects commonly attributed to OCs, were also similar between groups (p > 0.05). No serious, unexpected, drug-related adverse events occurred during the study. The low-dose OC containing 20 microg EE/100 microg LNG is safe, well tolerated, and does not cause weight gain.

journal_name

Contraception

journal_title

Contraception

authors

Coney P,Washenik K,Langley RG,DiGiovanna JJ,Harrison DD

doi

10.1016/s0010-7824(01)00208-6

subject

Has Abstract

pub_date

2001-06-01 00:00:00

pages

297-302

issue

6

eissn

0010-7824

issn

1879-0518

pii

S0010782401002086

journal_volume

63

pub_type

临床试验,杂志文章,多中心研究,随机对照试验

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