Browsing by Author "A. Kazi"

Filter results by typing the first few letters
Now showing 1 - 3 of 3
  • No Thumbnail Available
    PublicationMetadata only
    A multicentred phase III comparative clinical trial of depot-medroxyprogesterone acetate given three-monthly at doses of 100mg or 150 mg: II. The comparison of bleeding patterns. World health organization task force on long-acting systemic agents for fertility regulation special programme of research, development and research training in human reproduction
    (1987-01-01) S. Said; K. Omar; Suporn Koetsawang; Orawan Kiriwat; Yuwadee Srisatayapan; A. Kazi; F. Ajmal; H. H. Wynter; A. Pretnar-Darovec; I. B. Benitez; J. de la Cruz; R. Apelo; L. Kovacs; S. Koloszar; C. d'Arcangues; B. Busca; P. E. Hall; D. Machin; El-Shatby University Hospital; Mahidol University; National Research Institute of Fertility Control; University of the West Indies; Hospital for Gynaecology and Obstetrics; University of the Philippines System; University of Szeged Faculty of Medicine; Organisation Mondiale de la Sante
    A multicentered phase III clinical trial was conducted in seven countries to compare two dosages of depot-medroxy progesterone acetate (DHPA), 100mg and 150mg, given every 90 days. Contraceptive efficacy and side-effects of both regimens were reported previously. Their effect on vaginal bleeding patterns is the object of this paper. A total of 1216 women were randomly assigned to a dose group and 1156 of them provided a menstrual diary. The comparison of the bleeding patterns is made using a 90-day reference period approach and following the guidelines published by WHO. In addition, the longest bleeding/spotting episode and the longest bleeding/spotting-free interval are calculated over the entire diary lengtn. The only dirterence found between the two dose groups is a higher incidence of amenorrhea with the 150mg regimen. Overall, there is a high degree of consistency between the reasons given by individual women for discontinuing the contraceptive method and their vaginal bleeding pattern during the 90 days preceding discontinuations. However the data revealed large between-centre differences, both in the incidence of specific patterns, and in the identification by women of bleeding problems as reasons for discontinuation. This last point suggests that the life-table analysis underestimates the true incidence of menstrual irregularities. Comments on the reference period analysis method are made. © 1987 Geron-X, Inc.
  • No Thumbnail Available
    PublicationMetadata only
    A multicentred phase III comparative clinical trial of depot-medroxyprogesterone acetate given three-monthly at doses of 100mg or 150mg: 1. Contraceptive efficacy and side effects
    (1986-01-01) S. Said; K. Omar; Suporn Koetsawang; Orawan Kiriwat; Yuwadee Srisatayapan; A. Kazi; F. Ajmal; H. H. Wynter; A. Pretnar-Darovec; I. B. Benitez; J. de la Cruz; R. Apelo; L. Kovacs; S. Koloszar; B. Busca; P. E. Hall; D. Machin; El-Shatby University Hospital; Mahidol University; National Research Institute of Fertility Control; University of the West Indies; Hospital for Gynaecology and Obstetrics; University of the Philippines System; University of Szeged Faculty of Medicine; Organisation Mondiale de la Sante; University of Southampton
    Two dosages of depot-medroxyprogesterone acetate (DMPA), 100mg and 150mg given every 90 days, were compared in two groups of women with regard to effectiveness, reported complaints and reasons for discontinuation. A total of 1216 women were recruited into a seven-centre, multinational, randomized clinical trial. Follow-up was for a period of one year and resulted in a total of 5507 woman-months of experience of 100mg DMPA and 5429 woman-months of experience of the 150mg dose. The study showed little difference in efficacy and side effects between the two treatment groups. Two pregnancies occurred in women receiving 100mg DMPA giving a Pearl Index of 0.44 per 100 woman-years. None occurred in the 150mg group. There was no difference in the overall continuation rates between the two groups at one year, being 59.3% in the 100mg group and 58.8% in the 150mg group. Except for discontinuation of method use for amenorrhea, the rates of all medical and non-medical reasons given for discontinuation were comparable between the two treatment groups. Women's perception of lack of bleeding was reported as amenorrhea and resulted in discontinuation rates at 12 months for amenorrhea of 7.2% for women receiving 100mg of DMPA and 12.5% for those receiving the 150mg dose. Three centres, Alexandria, Karachi and Szeged, made the major contributions to this difference. © 1986.
  • No Thumbnail Available
    PublicationMetadata only
    A multicentred phase III comparative study of two hormonal contraceptive preparations given once-a-month by intramuscular injection. II. The comparison of bleeding patterns
    (1989-01-01) World Health Organization; Task Force On Long-Acting Systemic Agents for Fertility Regulation; S. Said; W. Sadek; A. Kholeif; Suporn Koetsawang; Orawan Kiriwat; Surat Piboonmanee; R. Rivera; G. Alvarado; M. A. Juarez; S. Aquilar; R. Santiso; C. F. Contreras; L. F. Galichl; M. Guirola; M. G. Alzugaray; M. L. Hernandez; J. R. Gallarco; B. Affandi; S. S.I. Santoso; R. S. Samil; A. Kazi; E. S. Kononova; V. I. Alipov; R. Apelo; E. S. Bernardo; I. Benitez; T. Canto-de-Cetina; S. Cardenas; L. Polanco; L. Vera; M. C. Cravioto; L. Hernandez; J. L. Fuziwara; J. Garza-Flores; G. Perez-Palacios; G. Oropeza; E. Mota; E. Zavaleta; G. Benagiano; C. Bastianelli; A. Diaz Infante-Ibarra (deceased); C. J. Castelo; R. Jiminez; N. Perez-Arocha; J. Lang-Prieto; J. A. Casas-Fernandez; H. M. Perez-Paz (deceased); M. Perez; A. R. Hernandez; C. Bustillo Tur; L. Kovacs; S. Koloszar; S. Bassol; A. M. Trujillo; R. Guzman-Serani; E. Israel; C. d'Arcangues; B. Busca; P. E. Hall; D. Machin; A. Pinol; F. Schlagenhaft; Development and Research Training in Human Reproduction; El-Shatby University Hospital; Mahidol University; Universidad Juarez del Estado de Durango; Asociacion Pro-Bienestar de la Familia de Guatemala (APROFAM); Instituto Nacional de Endocrinologia y Enfermedades Metabolicas; Universitas Indonesia; National Research Institute of Fertility Control; Russian Academy of Medical Sciences; Dr. Jose Fabella Memorial Hospital; Universidad Autonoma de Yucatan, Facultad de Medicina; Instituto Nacional de Nutricion; Hospital General de Mexico; Universita degli Studi di Roma La Sapienza; Universidad Autonoma de San Luis Potosi; Hospital Provincial Docente 'Saturnino Lora'; University of Szeged Faculty of Medicine; Universidad Autonoma de Coahuila; Universidad Austral de Chile; Organisation Mondiale de la Sante; University of Southampton
    A multicentred Phase III clinical trial was conducted in 12 countries to compare HRP112 (depot-medroxyprogesterone acetate, 25 mg and estradiol cypionate, 5 mg) and HRP102 (norethisterone enantate, 50 mg and estradiol valerate, 5 mg) given every 28 days. Contraceptive efficacy and side-effects of both regimens were reported previously. Their effect on vaginal bleeding patterns is the object of this paper. A total of 2320 women were randomly assigned to each drug and 2000 of them provided a menstrual diary. The comparison of the bleeding patterns is made using a 90-day reference period approach and following the guidelines published by WHO. The analysis failed to identify any major difference in the vaginal bleeding patterns induced by both contraceptive preparations. For both drugs, the first bleeding episode following the first injection occurs early. For 70% of users, this is followed by a regular vaginal bleeding pattern similar to an untreated pattern. Others experience irregular bleeding and a few have either infrequent or frequent bleeding. The extremes of amenorrhea and prolonged bleeding are rare. There are no major trends in vaginal bleeding patterns with prolonged use of either preparation. Women with the worst vaginal bleeding patterns discontinue early in the clinical trial and the last three months of experience have the most influence in their decision to stop using the contraceptive method. The analysis suggests how the life-table analysis of discontinuation reasons underestimates the true incidence of vaginal bleeding irregularities in a clinical trial. © 1989.