An open-label study of subdermal implants of estradiol-only versus subdermal implants of estradiol plus nomegestrol acetate: effects on symptom control, lipid profile and tolerability.
OBJECTIVE
To compare the effects of continuous 17-beta estradiol-only silastic implants with those of continuous 17-beta estradiol plus continuous nomegestrol acetate silastic implants on symptom control, lipid profile and tolerability in postmenopausal women.


METHODS
This was an open-label, parallel-group study. Women with and without uterus and no contraindications to hormone therapy (HT) in this study, we consider as HT the replacement of Estrogens-only and Estrogens + Progestogens Therapy, were enrolled. Each subject was assigned to receive four 17-beta estradiol-only silastic implants (women without uterus), or four 17-beta estradiol plus one nomegestrol acetate silastic implant (women with intact uterus), for 1 year.


RESULTS
A total of 40 subjects were enrolled and received, the silastic implants of which 40 (100.0%) subjects completed the study (n = 20, estradiol only; n = 20, estradiol plus nomegestrol acetate). The incidence of postmenopausal symptoms decreased significantly. No significant decreases in total cholesterol (1.3%), low-density lipoprotein cholesterol (1.1%), triglycerides (1.2%) and fasting glucose ((1.3%) serum levels were observed in both groups, whereas high-density lipoprotein (HDL) cholesterol increased significantly (2.8%), during the study in both groups. The incidences of adverse events were similar in both treatment groups.


CONCLUSIONS
Women treated with 17-beta estradiol-only silastic implants or 17-beta estradiol plus nomegestrol acetate silastic implants showed significant improvement of postmenopausal symptoms, including urogenital and sexual health symptoms and a significant increase in HDL cholesterol and no significant differences in other lipid profiles and tolerability.
Barbosa
Ione Cristina
IC
Maternidade Climério de Oliveira, Teaching Hospital, Federal University of Bahia, Bahia, Brazil. barbosaic@terra.com.br
Coutinho
Elsimar Metzker
EM
Oladapo
Ladipo
L
Noronha
Cristina Fernandes
CF
Mota
Regina Lucia Santos
RL
Lopes
Antonio Carlos Vieira
AC
Lopes
Renata Cruz
RC
D020405:Dermis; D004129:Dimethylpolysiloxanes; D004343:Drug Implants; D004359:Drug Therapy, Combination; D004414:Dyspareunia / Q000188:drug therapy; D004958:Estradiol / Q000008:administration & dosage* / Q000009:adverse effects; D015914:Estrogen Replacement Therapy / Q000379:methods*; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy; D006801:Humans; D008055:Lipids / Q000097:blood*; D008535:Megestrol / Q000008:administration & dosage* / Q000009:adverse effects; D008598:Menstruation / Q000187:drug effects; D008875:Middle Aged; D009649:Norpregnadienes / Q000008:administration & dosage* / Q000009:adverse effects; D014623:Vaginal Diseases / Q000188:drug therapy; D015430:Weight Gain / Q000187:drug effects
D004129:Dimethylpolysiloxanes; D004343:Drug Implants; D008055:Lipids; D009649:Norpregnadienes; D004958:Estradiol; C013830:baysilon; C038501:nomegestrol acetate; D008535:Megestrol