The effects of nomegestrol acetate subdermal implant (Uniplant) on carbohydrate metabolism, serum lipoproteins and on hepatic function in women.
This study was undertaken to assess possible variations in body weight, blood pressure, fasting glucose, HbA1C, insulin, total cholesterol, HDL-C, LDL-C, triglycerides, SGPT, SGOT, GGT and bilirubin in women bearing a single subdermal Silastic implant containing 55 mg (10%) of nomegestrol acetate during two years. A total of eighteen volunteers of reproductive age who desired to avoid conception were enrolled in this study. Subjects were healthy women with no contraindications to hormonal contraception. All women were investigated before starting treatment and were followed up for one year. At the end of one year the capsules were removed and a new capsule was inserted. Fasting blood samples were drawn at 8:00 to 8:30 am twice prior to implant insertion and then at the first, third, sixth and twelfth months and every six months thereafter. Body weight increased from 54.9 +/- 1.5 kg at admission to 55.3 +/- 2.0 kg at 12 months of use (p < 0.05) and to 56.0 +/- 2.7 kg at 24 months of use. A slight increase in both systolic and diastolic blood pressure was recorded at month 12 (p < 0.01). At month 24, blood pressure was not significantly different from admission values. All levels were within the normal range. Insulin, HbA1C, LDL-C and GGT remained unchanged during twenty-four months of Uniplant use. A significant decrease in total cholesterol (p < 0.05) was observed in the third month while a significant decrease in HDL-C (p < 0.01) was observed only in the sixth month of Uniplant use.(ABSTRACT TRUNCATED AT 250 WORDS)
Barbosa
I
I
Federal University of Bahia, Maternidade Climerio de Oliveira, Salvador, Brazil.
Coutinho
E
E
Athayde
C
C
Ladipo
O
O
Olsson
S E
SE
Ulmsten
U
U
D000293:Adolescent; D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D001219:Aspartate Aminotransferases / Q000097:blood; D001663:Bilirubin / Q000097:blood; D001786:Blood Glucose / Q000032:analysis; D001794:Blood Pressure / Q000187:drug effects / Q000502:physiology; D050260:Carbohydrate Metabolism; D002784:Cholesterol / Q000097:blood; D004343:Drug Implants; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007328:Insulin / Q000097:blood; D008074:Lipoproteins / Q000097:blood*; D008099:Liver / Q000187:drug effects / Q000502:physiology*; D008535:Megestrol / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000494:pharmacology; D045167:Progesterone Congeners / Q000008:administration & dosage / Q000494:pharmacology*; D014280:Triglycerides / Q000097:blood; D005723:gamma-Glutamyltransferase / Q000097:blood
D000410:Alanine Transaminase; D001219:Aspartate Aminotransferases; D001663:Bilirubin; D001786:Blood Glucose; D002784:Cholesterol; D004343:Drug Implants; D006442:Glycated Hemoglobin; D007328:Insulin; D008074:Lipoproteins; D008535:Megestrol; D045167:Progesterone Congeners; D014280:Triglycerides; D005723:gamma-Glutamyltransferase; C047637:nomegestrol