Hormone withdrawal-associated symptoms: comparison of oestradiol valerate/dienogest versus ethinylestradiol/norgestimate.
Eur J Contracept Reprod Health Care
; 18(4): 274-83, 2013 Aug.
Article
em En
| MEDLINE
| ID: mdl-23638631
ABSTRACT
OBJECTIVES:
To determine the effect of oestradiol valerate/dienogest (E2V/DNG) versus ethinylestradiol/norgestimate (EE/NGM) on hormone-withdrawal associated symptoms (HWAS) in otherwise healthy women who had experienced at least one of these symptoms when using 21/7-day combined oral contraceptives (COCs).METHODS:
This phase III, parallel-group study randomised 409 women aged 18 to 50 years to E2V/DNG or EE/NGM. The primary efficacy variable was the change from baseline to cycle 6 in the average of the three highest visual analogue scale values for headache and/or pelvic pain during cycle days 22 to 28.RESULTS:
In total, 395 were included in the full analysis set (E2V/DNG, n = 191; EE/NGM, n = 204). E2V/DNG reduced the symptoms of headache or pelvic pain during cycle days 22 to 28 from baseline to cycle 6 to a significantly greater extent than EE/NGM (mean decrease 43.6 vs. 35.5 mm; p = 0.0024). Both treatments were well tolerated with a similar proportion of women experiencing adverse events that were considered at least possibly related to treatment (35% E2V/DNG vs. 34% EE/NGM).CONCLUSIONS:
E2V/DNG reduces the frequency and intensity of headache and pelvic pain to a greater extent than EE/NGM, and may be a good option for women susceptible to HWAS with conventional 21/7-day COCs.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Contexto em Saúde:
2_ODS3
Problema de saúde:
2_sustancias_psicoativas
Assunto principal:
Síndrome de Abstinência a Substâncias
/
Dor Pélvica
/
Anticoncepcionais Orais
/
Estradiol
/
Etinilestradiol
/
Cefaleia
/
Nandrolona
/
Norgestrel
Tipo de estudo:
Clinical_trials
/
Diagnostic_studies
/
Risk_factors_studies
Limite:
Adult
/
Female
/
Humans
Idioma:
En
Revista:
Eur J Contracept Reprod Health Care
Assunto da revista:
MEDICINA REPRODUTIVA
/
SERVICOS DE PLANEJAMENTO FAMILIAR
Ano de publicação:
2013
Tipo de documento:
Article
País de afiliação:
Estados Unidos