Intrauterine administration of levonorgestrel in two low doses in HRT. A randomized clinical trial during one year: effects on lipid and lipoprotein metabolism.
OBJECTIVE
To investigate the effects on lipid and lipoprotein metabolism of two doses (5- or 10 micrograms/24 h) of levonorgestrel released from an intrauterine device (IUD) in combination with orally administered estradiol (2 mg estradiol valerate) in perimenopausal women.


METHODS
A 1-year prospective randomized single blind clinical trial.


METHODS
Department of Obstetrics and Gynaecology, Ostra Hospital, Göteborg, Sweden.


METHODS
Fifty-one perimenopausal women with climacteric symptoms.


METHODS
Cholesterol in serum and in lipoprotein fractions; high-density lipoprotein (HDL), low-density lipoprotein (LDL). Triglycerides in serum and in very low-density lipoprotein.


RESULTS
In both treatment groups significant elevations in HDL-cholesterol of similar magnitude were observed after 1 month and these changes were maintained during the 12 month observation period. In both treatment groups an initial significant decrease of LDL-cholesterol was observed and the decrement was maintained after 12 months. Serum levels of cholesterol decreased significantly in both groups after 1 month and were maintained after 12 months in the levonorgestrel-IUD (LNG-IUD) 5 micrograms group. However, the initial reduction of serum cholesterol in the LNG-IUD 10 micrograms group did not differ from baseline after 12 months. Serum triglyceride levels fluctuated during the observation period. No significant changes occurred.


CONCLUSIONS
Continuous combined HRT with intrauterine administration of levonorgestrel, 5- or 10 micrograms/24 h, in perimenopausal women was observed to increase HDL-cholesterol and to decrease LDL-cholesterol compared with pretreatment values. The low doses of levonorgestrel did not reverse the beneficial effects on lipid metabolism usually seen after estradiol administration.
Wollter-Svensson
L O
LO
Department of Obstetrics and Gynaecology, University Hospital of Uppsala, Sweden.
Stadberg
E
E
Andersson
K
K
Mattsson
L A
LA
Odlind
V
V
Persson
I
I
D000284:Administration, Oral; D002784:Cholesterol / Q000097:blood; D002979:Climacteric / Q000097:blood / Q000187:drug effects*; D004359:Drug Therapy, Combination; D004958:Estradiol / Q000008:administration & dosage / Q000031:analogs & derivatives; D015914:Estrogen Replacement Therapy; D004966:Estrogens, Conjugated (USP) / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007436:Intrauterine Devices, Medicated; D016912:Levonorgestrel / Q000008:administration & dosage* / Q000009:adverse effects; D008055:Lipids / Q000097:blood*; D008074:Lipoproteins / Q000097:blood*; D008875:Middle Aged; D011446:Prospective Studies; D014280:Triglycerides / Q000097:blood
D004966:Estrogens, Conjugated (USP); D008055:Lipids; D008074:Lipoproteins; D014280:Triglycerides; D004958:Estradiol; D016912:Levonorgestrel; D002784:Cholesterol