Comparative phase III clinical trial of two injectable contraceptive preparations, depot-medroxyprogesterone acetate and Cyclofem, in Vietnamese women.
A multicenter clinical trial was conducted in Viet Nam, comparing two injectable contraceptive preparations: the three-monthly injectable depot-medroxyprogesterone acetate (DMPA) and the once-a-month injectable Cyclofem. A total of 600 volunteers were randomized to the two treatment groups and followed for one year. No pregnancy occurred during the trial. Approximately one quarter of the women in each group discontinued early from the trial. In the DMPA group, this was mostly because of amenorrhea and vaginal bleeding irregularities. In the Cyclofem group, an equal number discontinued because of menstrual problems and personal reasons. These personal reasons are probably related to the inconvenience of having to return to the clinic for injection on a monthly basis. Thus, Vietnamese women experience less side effects with Cyclofem than with DMPA, and once Cyclofem is made more widely available and is more accessible, it may better meet their needs than does DMPA.
Institute for the Protection of Mother and Newborn, Hanoi, Viet Nam.
D T
DT
Cuong
N T
NT
My Huong
D000328:Adult; D001794:Blood Pressure / Q000187:drug effects; D001835:Body Weight / Q000187:drug effects; D003271:Contraceptive Agents, Female / Q000008:administration & dosage / Q000009:adverse effects*; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage / Q000009:adverse effects; D004338:Drug Combinations; D004958:Estradiol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D015993:Life Tables; D008137:Longitudinal Studies; D017258:Medroxyprogesterone Acetate / Q000008:administration & dosage / Q000009:adverse effects*; D008599:Menstruation Disturbances / Q000139:chemically induced* / Q000188:drug therapy; D015337:Multicenter Studies as Topic; D010352:Patient Dropouts / Q000706:statistics & numerical data; D018579:Patient Selection; D016312:Treatment Refusal / Q000706:statistics & numerical data; D014592:Uterine Hemorrhage / Q000139:chemically induced* / Q000145:classification / Q000188:drug therapy; D014744:Vietnam
D003271:Contraceptive Agents, Female; D003277:Contraceptives, Oral, Combined; D004338:Drug Combinations; D004958:Estradiol; C034528:CycloProvera; D017258:Medroxyprogesterone Acetate