A clinical study of transdermal contraceptive patch in Thai adolescence women.

OBJECTIVE: To study cycle control, compliance and safety of a transdermal contraceptive patch in adolescent Thai women. MATERIAL AND METHOD: Fifty-eight healthy women were assigned to receive 3 cycles of contraceptive patch (ethinyl estradiol 20 microg and norelgestromin 150 microg/day). All participants aged 16-20 years were invited to participate from the family planning clinic at King Chulalongkorn Memorial Hospital. Data were collected on adverse effects, perceived advantages and disadvantages, body weight, blood pressure, patch detachments and compliance. Data were analyzed using mean, percentage and student's t-test. RESULTS: The participants' average age was 19.4 years, height 158.8 cm, weight 51.8 kg, BMI 20.8 Kg/m2. The most location of patch application was the abdomen and the most adverse event was breast tenderness (31.0%) followed by application site reaction, nausea vomiting and headache respectively. The breast symptom was mild in severity. The participants reported decrease in dysmenorrhea and shorter duration of bleeding. There were no significant changes in body weight and blood pressure. The improvement of their facial acne was reported. There were no pregnancies during use and the adhesion of the contraceptive patch is excellent. Partial patch detachment was reported in only 6.9%. No completed patch detachment was found. CONCLUSION: The present study found an overall positive impression of a new transdermal contraceptive patch. The good compliance and few side effects were demonstrated. The adhesive patch contraceptive was excellent.

A clinical study of transdermal contraceptive patch in Thai women.

OBJECTIVE: To study cycle control, compliance and safety of a transdermal contraceptive patch in Thai women. MATERIAL AND METHOD: Sixty-nine healthy women were assigned to receive 3 cycles of contraceptive patch (ethinyl estradiol 20 microg and norelgestromin 150 miccrog/day). All participants aged 18-45 years were invited to participate at the family planning clinic at King Chulalongkorn Memorial Hospital. Adverse effects, perceived advantages, and disadvantages were collected. RESULTS: The participants averaged 22.4 years old, height 158.9 cm, weight 52.5 kg, BMI 20.7. The most common location of patch application was abdomen and the most adverse event was application site reaction (29%) followed by breast tenderness, nausea vomiting, and headache. The breast symptom was mild in severity. The participants reported decrease in dysmenorrhea and shorter duration of bleeding. Only 1.1% had breakthrough bleeding. There were no significant changes in body weight and blood pressure. Improvement of their facial acne was reported. There were no pregnancies during the use and the adhesion of contraceptive patch was excellent, partial patch detachment was reported at only 14.4%. No complete patch detachment was found. CONCLUSION: The study found an overall positive impression of new transdermal contraceptive patch. Good compliance and few side effects were demonstrated. The adhesive of the contraceptive patch was excellent.

Norelgestromin/ethinyl estradiol transdermal system.

The transdermal contraceptive patch is an innovative contraceptive technology. The failure rate is quite low and has high continuation rate. The side effects and complications are not different from other hormonal contraceptives. This contraceptive method should be an alternative birth control technique for women.

Current status of fertility control methods in India.

Approximately 48.2% of couples of 15 to 49 years of age practice family planning methods in India. Female sterilization accounts for 34.2%, with male sterilization declining from 3.4% in 1992-93 to 1.9% in 1998-99. Use of the condom increased to 3.1% from 2.4%. There is an urgent need for research to develop new contraceptive modalities especially for men and also for women and to make existing methods more safe, affordable and acceptable. Current efforts in India to develop a male contraceptive are mainly directed towards (i) development of antispermatogenic agents to suppress sperm production, (ii) prevention of sperm maturation, (iii) prevention of sperm transport through vas deferens or rendering these sperm infertile and (iv) prevention of sperm deposition. Research work in the field of prevention of sperm transport through vas deferens has made significant advances. Styrene maleic anhydride (SMA) disturbed the electrical charge of spermatozoa leading to acrosome rupture and consequent loss in fertilizing ability of sperm. A multicentre phase-III clinical trial using SMA is continuing and it is hoped that the SMA approach would be available in the near future as an indigenously developed injectable intra-vasal male contraceptive. The safety and efficacy of available oral contraceptives were evaluated. An indigenously developed oral contraceptive 'Centchorman', which is a nonsteroidal, weakly estrogenic but potently antiestrogenic, was found to be safe and effective and is now being marketed in India since 1991 as a 'once a week' pill. Cyclofem and Mesigyna have been recommended as injectable contraceptives with proper counselling and service delivery by Indian studies. It has been recommended that these injectable contraceptives be added to the existing range of contraceptive methods available in the National Family Planning Programme. Based on the Indian studies CuT 200 was also recommended. Studies have indicated the advantage of intrauterine devices (IUD); they are long acting, relatively easily removed and fertility returns rapidly after their removal. Recent studies have recommended CuT 200 for use up to 5 years. The combination of some plant products i.e. Embelia ribes, Borax and Piper longum has been found to be safe and effective as a female contraceptive and the results of phase-I clinical trials are encouraging. Research work is going on in the country in various areas with special reference to hormonal contraceptive - a three monthly injectable contraceptive, immuno-contraceptives, antiprogestins, etc.

Seguimiento a largo plazo de mujeres tratadas con implantes anticonceptivos de Levonorgestrel Norplant / Long-term follow up of women treated with contraceptive implants of norplant levonorgestrel

Este trabajo describe el seguimiento a largo plazo de 376 mujeres que recibieron los implantes Norplant durante el período comprendido entre octubre de 1974 y mayo de 1979. En ciento diez de estos casos, se reemplazaron los implantes luego de diferentes plazos de uso del primer set. Los niveles promedios de levonorgestrel plasmático declinaron en forma paulatina a través de ocho años de uso continuo de las cápsulas Norplant (r=937). Los valores fueron 0,35 ng/ml, 0,29 ng/ml y 0,22 ng/ml durante el primer, quinto y octavo año de tratamiento, respectivamente. Luego de la extracción de Norplant y su reemplazo con un segundo set de implantes, los niveles de levonogestrel plasmático fueron similares a aquellos observados después de la primera inserción, tanto cuando se colocaron en el mismo lugar que el primer set como cuando se ubicaron en un área diferente. Se estableció que la vida media del levonorgestrel en plasma después del retiro de los implantes es de 42 ñ 16 h (x ñ D. S) y que sólo quedaban cantidades mínimas en circulación después de 96 h. Durante 18.530 meses-mujer de uso del primer set de implantes se produjeron diecinueve embarazos, once de ellos entre el sexto y octavo año de tratamiento. El índice de Pearl para los primeros cinco años de uso de implantes Norplant fue 0,63. En los 5.020 meses-mujer observadas durante el tratamiento con un segundo set de cápsulas no se ha producido ningún embarazo. Cincuenta y seis mujeres (14,9%) de las 376 usuarias del primer implante, y doce (10,9%) de las 110 mujeres que aceptaron el reemplazo de los implantes se retiraron del estudio por razones médicas, principalmente efectos secundarios asociados frecuentemente con la contracepción hormonal..