Transdermal oestradiol gel in the treatment of the climacterium: a comparison with oral therapy.
OBJECTIVE
To compare two doses of a transdermal oestradiol gel (Divigel/Sandrena) plus oral sequential medroxyprogesterone acetate (MPA) with oral oestradiol valerate plus oral sequential MPA (Divina/Dilena).


METHODS
Two year, randomised, open-label, comparative study.


METHODS
Menopausal outpatient clinic in Helsinki.


METHODS
Postmenopausal women with climacteric complaints or already using HRT.


METHODS
(1) One gram gel containing 1 mg oestradiol for 3 months plus 20 mg oral MPA during the last 14 days; (2) 2 g gel containing 2 mg oestradiol for 21 days plus 10 mg oral MPA during the last 14 days; (3) 2 mg oestradiol valerate tablets for 3 weeks plus 10 mg oral MPA during the last 10 days. In all groups, each treatment period was followed by a 7-day medication-free interval.


METHODS
Climacteric complaints, bleeding control, bone mineral density, biomarkers of bone metabolism, lipid profile, tolerability and safety.


RESULTS
With each preparation, climacteric complaints were significantly reduced and good bleeding control was obtained. In addition, maintenance of bone mineral density as well as a reduction of bone turnover was achieved in all groups. Lipid parameters showed no unfavourable changes. Continuation rates were similar in all groups with overall 74% of patients completing the first year, whereas 94% of patients who elected to continue completed the second year. Tolerability of the gel was good: only 1.7% of patients discontinued treatment due to skin irritation.


CONCLUSIONS
Transdermal oestradiol gel and oral oestradiol valerate tablets, used in combination with oral sequential MPA, are effective regimens of HRT in postmenopausal women. Transdermal oestradiol gel is an efficient, well-tolerated form of HRT.
Hirvonen
E
E
Department of Obstetrics and Gynecology, Helsinki University Central Hospital, Finland.
Lamberg-Allardt
C
C
Lankinen
K S
KS
Geurts
P
P
Wilén-Rosenqvist
G
G
D000279:Administration, Cutaneous; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D015519:Bone Density / Q000187:drug effects; D002784:Cholesterol / Q000097:blood; D002979:Climacteric; D004958:Estradiol / Q000008:administration & dosage* / Q000009:adverse effects; D015914:Estrogen Replacement Therapy / Q000009:adverse effects / Q000379:methods*; D005260:Female; D005782:Gels; D019584:Hot Flashes; D006801:Humans; D017258:Medroxyprogesterone Acetate / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D045167:Progesterone Congeners / Q000008:administration & dosage* / Q000009:adverse effects; D013546:Sweating; D016312:Treatment Refusal; D014592:Uterine Hemorrhage / Q000517:prevention & control
D005782:Gels; D045167:Progesterone Congeners; D004958:Estradiol; D002784:Cholesterol; D017258:Medroxyprogesterone Acetate