Open prospective multicenter trial with a new monophasic contraceptive combination containing gestodene.
Contraception
; 43(5): 413-21, 1991 May.
Article
em En
| MEDLINE
| ID: mdl-1914456
ABSTRACT
PIP: In a large and open prospective multicenter trial of 12,250 cycles from 2378 women, contraceptive efficacy, clinical tolerance, and acceptability of a new monophasic oral contraceptive (OC) containing 75 mcg gestodene (delta-5-levonorgestrel) and 30 mcg ethinyl estradiol (EE) were studied. The objective was to assess efficacy, safety, side effects, and cycle control for this OC on healthy women using no other additional birth control methods. 2 women became pregnant (0.016%) during the trial; both were patient failures. There were no side effects on systolic or diastolic pressure. An average weight increase of 0.3 kg was noted. Cycle control was excellent with 95% of the cycles free of spotting and 98% free of breakthrough bleeding after 6 cycles. no serious complications occurred. There was an overall incidence of 14% who reported side effects after 6 cycles, indicating that the hormonal combination is well-tolerated. It should be noted that 41.4% of the patients had some complaint prior to the start of treatment. For all complaints, a highly significant improvement was seen during treatment.
Palavras-chave
Acceptor Characteristics; Acceptors; Belgium; Biology; Bleeding; Blood Pressure--changes; Contraception; Contraception Termination; Contraceptive Agents, Estrogen--side effects; Contraceptive Agents, Female--side effects; Contraceptive Agents, Progestin--side effects; Contraceptive Agents--side effects; Contraceptive Effectiveness; Contraceptive Methods--side effects; Contraceptive Usage; Developed Countries; Diseases; Ethinyl Estradiol--side effects; Europe; Family Planning; Family Planning Programs; Gestodene--side effects; Hemic System; Menstrual Cycle--changes; Menstruation; Method Acceptability; Oral Contraceptives, Combined--side effects; Oral Contraceptives--side effects; Physiology; Prospective Studies; Reproduction; Research Methodology; Signs And Symptoms; Studies; Western Europe
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Anticoncepcionais Orais Combinados
/
Norpregnenos
Tipo de estudo:
Clinical_trials
/
Observational_studies
/
Risk_factors_studies
Limite:
Adolescent
/
Adult
/
Female
/
Humans
Idioma:
En
Ano de publicação:
1991
Tipo de documento:
Article