Constant estrogen, intermittent progestogen vs. continuous combined hormone replacement therapy: tolerability and effect on vasomotor symptoms.
OBJECTIVE
To compare the efficacy and tolerability of a novel oral constant estrogen plus intermittent progestogen hormone replacement therapy (HRT) regimen to a continuous combined HRT regimen in postmenopausal women.


METHODS
Subjects were randomly assigned to receive treatment with either constant 17beta-estradiol (E2), 1 mg, plus intermittent norgestimate (NGM) 90 microg (3 days off, 3 days on) (n=221) or E2 2 mg/norethisterone acetate (NETA) 1 mg (n=217) for 1 year. Treatments were evaluated based on the incidence of hot flushes and uterine bleeding.


RESULTS
Both regimens had similar bleeding profiles and provided comparable vasomotor symptom relief. However, breast discomfort and edema were experienced by twice as many subjects who received E2/NETA.


CONCLUSIONS
The constant E2/intermittent NGM regimen was well tolerated and possesses similar efficacy compared with a continuous combined E2/NETA regimen and may be considered whenever HRT without withdrawal bleeding is deemed appropriate.
Rozenberg
S
S
St Pierre Hospital, Brussels, Belgium. serge.rozenberg@skynet.be
Caubel
P
P
Lim
P C
PC
D000328:Adult; D000368:Aged; D004334:Drug Administration Schedule; D004958:Estradiol / Q000008:administration & dosage; D015914:Estrogen Replacement Therapy / Q000379:methods; D004967:Estrogens / Q000008:administration & dosage* / Q000494:pharmacology; D005260:Female; D006801:Humans; D008875:Middle Aged; D009640:Norethindrone / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077563:Norethindrone Acetate; D009644:Norgestrel / Q000008:administration & dosage / Q000031:analogs & derivatives*; D017698:Postmenopause; D011372:Progestins / Q000008:administration & dosage* / Q000494:pharmacology; D014592:Uterine Hemorrhage / Q000139:chemically induced; D014666:Vasomotor System / Q000187:drug effects
D004967:Estrogens; D011372:Progestins; D009644:Norgestrel; D004958:Estradiol; D000077563:Norethindrone Acetate; C017576:norgestimate; D009640:Norethindrone