OBJECTIVE: Two studies (Studies A and B) were conducted to measure efficacy and safety of constant @entity53 (E2), pulsed norgestimate (NGM) hormone replacement therapy on @entity548 and vasomotor symptoms in postmenopausal @entity1 . NGM was pulsed in a 3-days-off/3-days-on fashion. Study A also assessed effects of treatment on vaginal cytology. STUDY DESIGN: In two 360-day, multicenter, double-blind, parallel-group studies, 1,253 subjects were randomized to receive daily, unopposed @entity10819 mg or one of three constant @entity172 , pulsed progestin regimens: @entity10819 mg/NGM 30 microg, @entity10819 mg/NGM 90 microg, or @entity10819 mg/NGM 180 microg. RESULTS: Bleeding control improved over time in @entity1 treated with @entity10819 mg/NGM 90 microg: 69% of @entity1 were free of @entity548 (irrespective of spotting) during month 1, 71% during month 6, and 80% during month 12. @entity10819 mg/NGM 30 microg had a lower incidence of @entity548 but provided inadequate endometrial protection. Among subjects with vasomotor symptoms at baseline, the percentage of asymptomatic subjects at the end of 3 months was 70% in the @entity10819 -mg group and 76% in the @entity10819 -mg/NGM 90-microg group. @entity10819 mg/NGM 90 microg was at least as effective as @entity10819 mg alone in causing maturation of vaginal epithelial cells. All regimens were well tolerated. CONCLUSION: Pulsed dosing of NGM 90 microg for 3 days off and 3 days on along with continuous administration of E2 is effective in treating vasomotor symptoms and @entity194 , provides endometrial protection (i.e., no cases of @entity1204 ), and has a @entity548 profile acceptable to the majority of @entity1 studied.

Efficacy and safety of a constant- XXXX , pulsed-progestin regimen in hormone replacement therapy.

@entity1 :: ('9606', 'Species') :: ['women'] @entity172 :: ('MESH:D004967', 'Chemical') :: ['estrogen'] @entity1204 :: ('MESH:D016889', 'Disease') :: ['endometrial hyperplasia or cancer'] @entity548 :: ('MESH:D006470', 'Disease') :: ['bleeding'] @entity53 :: ('MESH:D004958', 'Chemical') :: ['17beta-estradiol'] @entity194 :: ('MESH:D001284', 'Disease') :: ['vulvovaginal atrophy'] @entity10819 :: ('6044', 'Gene') :: ['E2 1']
@entity172 :: (MESH:D004967,Chemical) :: ['estrogen']
