Comparative study on the efficacy and acceptability of two contraceptive pills administered by the vaginal route: an international multicenter clinical trial.
Clin Pharmacol Ther
; 53(1): 65-75, 1993 Jan.
Article
en En
| MEDLINE
| ID: mdl-8422744
ABSTRACT
PIP: Efficacy and acceptability of 2 combined oral contraceptive pills administered vaginally are summarized. This is the 1st collaborative trial published by the South to South Cooperation in Reproductive Health. 1055 women participated in 12,630 cycles, in 9 countries, from June 1988 to May 1991. The pills were commercially available tablets containing 50 mcg ethinyl estradiol and 250 mg levonorgestrel (Schering AG, Sao Paulo, Brazil), or 30 mcg ethinyl estradiol and 15 mcg desogestrel (Organon, Sao Paulo, Brazil). Subjects were aged 17-39 younger and of lower parity from Mexico and Dominican Republic and older from Egypt and China. All had at least 1 pregnancy. 675 participated for 6 months, 470 for 1 year, 364 for 18 months, and 210 for 2 years. The 1-year discontinuation rate averaged 47.01% for the levonorgestrel group and 56.33% for the desogestrel group (p = 0.0061); 2-year discontinuation rates were 48.01% and 69.36, respectively, explained in part by higher involuntary pregnancy rates and prolonged bleeding rates in the desogestrel group. The most common medical reasons for stopping contraception were unplanned pregnancy, vaginal or vulval irritation, nausea, vaginal discharge and headache. Vaginal irritation was reported by 1%, 9 in each group. There were 32 pregnancies, 14 in the levonorgestrel and 18 in the desogestrel group. 17 were in missed pill cycles and the rest were method failures, 6 in the levonorgestrel group and 9 in the desogestrel group. The Pearl index varied from 0 in Nigeria to 12.24 in Mexico, and was 2.45 for levonorgestrel vs. 3.74 for desogestrel. There was a wide variation in discontinuation rates by center: Brazil and China had few, while many women from Dominican Republic, Mexico and Zambia left the study. Bleeding problems were common complaints, more so in the desogestrel group. There were 363 women with intermenstrual bleeding (only once in 80%), 148 with spotting (only twice in 65%). Bleeding duration was significantly less in pill cycles than baseline, pressure. Women gained an average of 1 kg over 2 years, more in the desogestrel group. The pregnancy rate of 2.78 is within the range reported for levonorgestrel rings.
Palabras clave
Africa; Africa South Of The Sahara; Americas; Arab Countries; Asia; Brazil; Caribbean; China; Clinical Research; Clinical Trials; Contraception; Contraception Continuation; Contraception Failure; Contraception Research; Contraception Termination; Contraceptive Agents; Contraceptive Agents, Estrogen; Contraceptive Agents, Female; Contraceptive Agents, Progestin; Contraceptive Methods--administraction and dosage; Contraceptive Usage; Cuba; Desogestrel; Developing Countries; Dominican Republic; Eastern Africa; Eastern Asia; Egypt; English Speaking Africa; Ethinyl Estradiol; Family Planning; Kenya; Latin America; Levonorgestrel; Mediterranean Countries; Method Acceptability; Mexico; Nigeria; North America; Northern Africa; Oral Contraceptives, Combined--administraction and dosage; Oral Contraceptives, Low-dose--administraction and dosage; Oral Contraceptives--administraction and dosage; Research Methodology; Research Report; South America; Western Africa; Zambia
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Bases de datos:
MEDLINE
Medicinas Complementárias:
Homeopatia
Asunto principal:
Levonorgestrel
/
Desogestrel
/
Etinilestradiol
Tipo de estudio:
Clinical_trials
Idioma:
En
Revista:
Clin Pharmacol Ther
Año:
1993
Tipo del documento:
Article
País de afiliación:
Brasil