Comparative study on the efficacy and acceptability of two contraceptive pills administered by the vaginal route: an international multicenter clinical trial.
The efficacy and acceptability of two widely used oral contraceptive tablets, one containing 250 mg levonorgestrel and 50 micrograms ethinyl estradiol and the other containing 150 micrograms desogestrel and 30 micrograms ethinyl estradiol, administered by the vaginal route were compared in 1055 women studied over 12,630 woman-months of vaginal contraceptive pill use. This multicenter clinical trial was performed in nine countries of the developing world by the "South to South Cooperation in Reproductive Health," an organization founded by scientists from the Third World working in the area of reproductive health, and the study was developed and coordinated by one of these centers. The findings of this study confirm the efficacy of both these tablets when administered by the vaginal route. Involuntary pregnancy rates at 1 year of 2.78 for subjects in the levonorgestrel group and 4.54 for subjects the desogestrel group showed no statistically significant difference between the two groups. However, total discontinuation rates of 47.01 for subjects in the levonorgestrel group and 56.33 for subjects in the desogestrel group showed a statistically significant difference between the two groups, and discontinuation rates attributable to prolonged bleeding of 0.6 for subjects in the levonorgestrel group and 3.2 for subjects in the desogestrel group were also significantly higher in the group of subjects using the desogestrel vaginal contraceptive pill. Blood pressure remained at admission values throughout treatment. A statistically significant weight increase from admission values occurred in both groups of subjects.
Coutinho
E M
EM
Maternidade Climério de Oliveira, Federal University of Bahia, Salvador, Brazil.
de Souza
J C
JC
da Silva
A R
AR
de Acosta
O M
OM
Alvarez
F
F
Brache
V
V
Garza Flores
J
J
Vasquez-Estrada
L
L
Santo
R
R
Bassol
S
S
D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D017135:Desogestrel / Q000008:administration & dosage* / Q000009:adverse effects; D003906:Developing Countries; D004338:Drug Combinations; D004997:Ethinyl Estradiol / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D016912:Levonorgestrel / Q000008:administration & dosage* / Q000009:adverse effects; D015337:Multicenter Studies as Topic; D010342:Patient Acceptance of Health Care; D011247:Pregnancy; D011897:Random Allocation; D014621:Vagina
D004338:Drug Combinations; D004997:Ethinyl Estradiol; D016912:Levonorgestrel; D017135:Desogestrel