Effect of sexual intercourse on the absorption of levonorgestrel after vaginal administration of 0.75 mg in Carraguard gel: a randomized, cross-over, pharmacokinetic study.

BACKGROUND: The Population Council studied a pre-coital contraceptive microbicide vaginal product containing levonorgestrel (LNG) as active component and Carraguard gel as a vehicle (Carra/LNG gel) for couples who engage in occasional unplanned intercourse. The objective of this study was to evaluate the effect of sexual intercourse after vaginal application of Carra/LNG gel on serum levels of LNG in women and to assess LNG absorption by the male partner. STUDY DESIGN: This was a randomized, cross-over, pharmacokinetic study including an abstinence arm and an arm in which couples engaged in sexual intercourse between 2 and 4 h after gel application. In each study arm, each woman received a single application of Carra/LNG gel (0.75 mg in 4 mL gel) followed by serial blood samples taken at 0, 1, 2, 4, 8, 24 and 48 h after gel application for LNG measurements. In the intercourse arm, LNG was measured in blood samples taken from the male partner before intercourse and at 4, 8 and 24 h after gel application in the female partner. RESULTS: Time concentration curves for serum LNG levels showed a mean C(max) of 7.8+/-5.5 and 8.3+/-5.7 nmol/L, a mean T(max) of 6.2+/-5.9 and 7.5+/-5.7, and comparable area under the curve for the intercourse and abstinence arm, respectively. Pharmacokinetic parameters presented large variability between subjects, but excellent reproducibility within each subject. LNG was undetectable in 10 out of 12 male partners. CONCLUSION: Sexual intercourse does not appear to interfere with vaginal absorption of LNG after application of a Carra/LNG gel. A vaginal pre-coital contraceptive gel is feasible.

Health and growth of infants breastfed by Norplant contraceptive implants users: a six-year follow-up study.

The objective of the study was to evaluate safety to infants whose mothers used Norplant levonorgestrel implants during breastfeeding. A nonrandomized clinical trial design was used. Participants were 220 and 222 healthy breastfed infants of mothers initiating use of Norplant or T-Cu IUD, respectively, at 55 days to 60 days postpartum. Infants were followed from birth through age 6 years. Breastfeeding pattern, infant growth, and disease events were recorded monthly in the first year, three-monthly in the second, and annually thereafter. Most mothers continued use of Norplant (96.4%) and T-Cu (94.1%) during lactation, and 2140 months of infant exposure to levonorgestrel were accumulated. Breastfeeding pattern and infants growth, from admission through age 6 years, were similar in both groups. In the first year, breastfed infants in the Norplant group had higher incidence rates (p < 0.05) of mild episodes of respiratory infections (adjusted RR 1.17, CI 1.08-1.27), skin conditions (adjusted RR 1.46, CI 1.20-1.79), and eye infections (unadjusted RR 1.49, CI 1.03-2.18) than the control group. Later on, a higher proportion of infants in the T-Cu group showed neurological conditions. Although breastfeeding patterns and infant growth is not affected by Norplant use during lactation, the effect on infants' health of steroidal contraception should be further evaluated.

Amenorrea, anovulación e infertilidad asociadas a la lactancia en un grupo seleccionado de mujeres urbanas / Amenorrhea, anovulation and infertility associated with breast feeding in a selected group of urban women

Se midió la influencia del amamantamiento sobre la duración de la amenorrea en un grupo de mujeres altamente motivadas para amamantar en libre demanda por un tiempo prolongado. Se calculó la probabilidad de presentar el primer sangrado en 676 mujeres en lactancia exclusiva al segundo mes postparto. El 52% presentó el primer sangrado estando en lactancia exclusiva, antes del término del sexto mes postparto. El tiempo transcurrido desde el parto y la suplementación influyeron negativamente en la duración de la amenorrea. Frecuencias de ocho o más mamadas en 24 hooras no lograron prolongar la amenorrea en todos los casos. El reinicio de los ciclos ovulatorios se estudió en 48 mujeres en amenorrea y lactancia exclusiva al tercer mes postparto. El 28% de las mujeres presentó el primer sangrado, y el 26% de los casos ovuló antes del término del sexto mes postparto. La probabilidad acumulada de embarazo fue de 9,4% al sexto mes postparto en las mujeres en lactancia exclusiva que no usaron métodos anticonceptivos. El riesgo fue menor del 2% en aquellos casos que permanecieron en amenorrea durante este período. En la población estudiada la lactancia no resultó un método eficaz para espaciar los nacimientos, con excepción de los casos que se mantuvieron con lactancia exclusiva y amenorrea