Efficacy and safety of a 28-day oral contraceptive with 7 days of low-dose estrogen in place of placebo.
Contraception
; 78(2): 113-9, 2008 Aug.
Article
em En
| MEDLINE
| ID: mdl-18672111
ABSTRACT
BACKGROUND:
The study was conducted to evaluate the efficacy and safety for the prevention of pregnancy of a 28-day oral contraceptive (OC) containing 150 mcg desogestrel (DSG)/20 mcg ethinyl estradiol (EE) for 21 days followed by 7 days of 10 mcg EE (Cette-28). STUDYDESIGN:
A 6-month, prospective, multicenter, single-arm study was conducted in 1302 women aged 18-45 years.RESULTS:
Over six cycles of treatment, the cumulative risk of pregnancy among all treated subjects (n=1262) was 0.9%. The Pearl Index for women 18-35 years of age (n=1042) was 2.20, including 9 pregnancies with estimated conception dates during active drug ingestion or up to 7 days after the last combination tablet. The rate of unscheduled bleeding was low and the duration of scheduled bleeding was approximately 2 days during each of the six treatment cycles. The safety profile was similar to what has been reported for other OCs.CONCLUSION:
This low-dose, 28-day OC incorporating 7 days of 10 mcg EE during the hormone free interval is effective and safe for the prevention of pregnancy and is well-tolerated by women.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Desogestrel
/
Anticoncepcionais Orais Sequenciais
/
Etinilestradiol
Tipo de estudo:
Clinical_trials
/
Etiology_studies
Limite:
Adult
/
Female
/
Humans
/
Pregnancy
Idioma:
En
Revista:
Contraception
Ano de publicação:
2008
Tipo de documento:
Article
País de afiliação:
Estados Unidos